Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Apan (2009)

Type of study:

RCT

Setting and country:

Hospital; Turkey

Funding and conflicts of interest:

The authors had no conflicts of interest to declare in relation to this article

Patients undergoing  elective cataract surgery under

local anaesthesia

Inclusion criteria:

• Age >18
• ASA 1-3

Exclusion criteria:

pregnancy, excessive obesity (i.e., body weight

>50% above ideal body weight for height), uncontrolled systemic pathology, known central nervous system disorder, debility or disease affecting

cooperation, history of sleep apnea, significant

arrhythmia or high degree atrioventricular nodal

block, and current or recent (within 30 days) treatment with as well as contraindication for α-2 agonists or antagonists

N total at baseline:

Intervention: 30

Control: 30

Important prognostic factors²:

Age, y mean (SD):

I: 66 (11)

C: 66 (12)

Sex: M/F

I:  18/12

C: 17/13

Groups comparable at baseline

0.25 µg×kg-1×hr-1 Dexmedetomidine.

25 µg × kg-1.hr1 midazolam

Length of follow-up:

From start of procedure-24hrs after the procedure (when they were called by a nurse for a telephone interview)

Loss-to-follow-up:

I: Not reported

C: Not reported

Patient satisfaction

Not reported

Provider satisfaction

Not reported

Sedation level

Not r eported

Recovery time

Recovery was evaluated and graded according to a

4-point rating scale in the recovery unit (1=patient

fully awake; 2=patient somnolent, but responds

to verbal commands; 3=patient somnolent, but

responds to tactile stimuli; 4=patient asleep, but

responds to pain), reported from 1-4 hours after operation, median

I: 2, 1, 1, 1

C: 2, 1,1 ,1

Hypoxemia

Not reported

Hypotension

Categorical outcome, not further defined

I: 0/30

C: 0/30

Remarks:

• The study is underpowered
• No remarks on primary/ secondary endpoints and unclear if all a-priori defined endpoints were studied

Authors conclusion:

‘Dexmedetomidine should be an alternative for intraoperative sedation in outpatient

cataract surgery.’

Liao (2012)

Type of study:

RCT

Setting and country:

Hospital; China

Funding and conflicts of interest:

The authors had no conflicts of interest to declare in relation to this article

postoperative

patients undergoing flexible bronchoscopy

Inclusion criteria:

• Adult patients
• ASA: unreported

Exclusion criteria:

Inability or

refusal to give informed consent,

bronchoscopy through an artificial airway, intolerance or allergy to the study drugs,

psychological disorders, dialysis of any type, acute hepatitis or severe liver disease (Child–

Pugh class C), respiratory failure, unstable angina or acute myocardial infarction, left

ventricular ejection fraction < 50%, heart

rate < 60 beats/min, second or third degree heart block, and systolic blood pressure < 90

mmHg despite continuous infusion with two different vasopressors before the start of study drug infusion.

N total at baseline:

Intervention: 99

Control: 98

Important prognostic factors²:

Age, y mean (SD):

I: 59 (9)

C: 60 (8)

Sex: M/F

I:  61/38

C: 62/36

Groups comparable at baseline

loading dose infusion of up to 1 μg/kg over 10 min could be administered at

the bronchoscopist’s discretion. The starting

maintenance infusion dose of dexmedetomidine was 0.5 μg/kg per hour.

2 mg midazolam,

followed by further 1 mg intravenous midazolam boluses during the procedure at the bronchoscopist’s discretion

Length of follow-up:

From start of procedure-end of procedure.

Loss-to-follow-up:

I: Not reported

C: Not reported

Patient satisfaction

Defined with a numerical rating scale ( zero being most satisfied and 10 least satisfied). Results shown with a median  (IQR).

I: 0 (0-0)

C: 0 (0-0)

Provider satisfaction

Defined with a numerical rating scale ( zero being most satisfied and 10 least satisfied). Results shown with a median (IQR).

I: 3 (2-5)

C: 4 (2-5)

Sedation level

Not reported

Recovery time

Not reported

Hypoxemia

SpO2<90% for > 30 s

I: 14/99

C: 18/98

Hypotension

systolic arterial pressure < 90 mmHg or mean arterial pressure < 60

mmHg during the procedure

I: 6/99

C: 7/98

Remarks:

• The study is underpowered for adverse events, potential of type II findings.

Authors conclusion:

‘Compared with midazolam, dexmedetomidine […] was equally well tolerated for conscious sedation in

postoperative patients undergoing bronchoscopy.’

Samson (2014)

Type of study:

RCT

Setting and country:

Tertiary care hospital; India

Funding and conflicts of interest:

The authors had no conflicts of interest to declare in relation to this article

Patients undergoing

diagnostic elective upper gastrointestinal endosopy

Inclusion criteria:

• Adult patients aged 18-60 years
• ASA: 1-2

Exclusion criteria:

Systemic hypertension, bleeding diathesis, prior

gastric surgeries, psychiatric diseases or long‑term antipsychotic

drug therapy, chronic use or addiction to opiates or sedatives,

presence of neoplastic or other serious concomitant diseases,

previous adverse reactions to any medication used in the

present study, baseline systolic blood pressure <90 mmHg,

allergy to eggs, history of sleep apnea and anticipated difficult

intubation

N total at baseline:

Intervention: 30

Control MDZ: 30

Control PF: 30

Important prognostic factors²:

Age, y mean:

I: 37 (10)

CMDZ: 34 (11)

CPF: 35 (11)

Sex: M/F

I:19/11

CMDZ: 18/12

CPF: 17/13

Groups comparable at baseline

An infusion of

1 μg/kg loading dose of dexmedetomidine over 10 min, followed by 0.5 μg/kg/h as a continuous infusion.

Group midazolam received

an infusion of 0.03 mg/kg loading dose of Midazolam followed by

0.06 mg/kg/h as continuous infusion.

Group propofol received an

infusion of 1 mg/kg loading dose of Propofol, followed by 3 mg/kg/h as

a continuous infusion.

Length of follow-up:

From start of procedure-end of procedure.

Loss-to-follow-up:

I: 0/30

CMDZ: 0/30

CPF: 0

Patient satisfaction

Defined with a categorical scale from 1-10, where category 1 was highest satisfaction.

Highest satisfaction:

I: 12/30

CMDZ: 28/30

RR 0.43 (95% CI, 0.27-0.67)

CPF: unreported

Provider satisfaction

Defined with a categorical scale from 1-10, where category 1 was highest satisfaction.

Highest satisfaction:

I: 18/30

CMDZ: 4/30

RR 4.50 (95% 1.73-11.73)

I: 18/30

CPF: 17/30

RR 1.06 (95% CI, 0.69-1.62)

Sedation level

Sedation level was reported as dose of fentanyl used for breakthrough sedation (mcg), mean (SD)

I: 19.2 (10.8)

CMDZ: 20 (10.2)

Mean difference -0.80 (95% CI, -6.12 to 4.52)

I: 19.2 (10.8)

CPF: 21.7 (8.6)

Mean difference -2.50 (95% CI, -7.44 to 2.44)

Recovery time

Recovery from sedation

was assessed using modified Aldrete score at 5 min after

removal of the endoscope and every 5 min thereafter until a

discharge score of 10/10 was reached. Results shown as mean minutes  (SD).

I: 7.7 (3.9)

CMDZ: 18.3 (3.8)

Mean difference -10.60 (95% CI, -12.55 to -8.65)

I: 7.7 (3.9)

CPF: 12.7 (2.9)

Mean difference -5.00 (95% CI, -6.74 to -3.26)

Hypoxemia

Not reported

Hypotension

Categorical outcome, not further defined

I: 3/30

CMDZ: 3/30

CPF: 13/30

Remarks:

• Prespecified outcomes outcomes are sometimes reported as ‘non-significant’ thereby prohibiting a numerical evaluation.

Authors conclusion:

‘Use of dexmedetomidine was associated with greater hemodynamic stability

and faster recovery when compared to propofol and midazolam.’

Kaya (2010)

Type of study:

RCT

Setting and country:

Hospital; Turkey

Funding and conflicts of interest:

The authors had no conflicts of interest to declare in relation to this article

Patients undergoing

undergoing TURP under

spinal anesthesia were included

Inclusion criteria:

• Adult patients aged 18-60 years
• ASA: 1-2

Exclusion criteria:

Exclusion criteria included

use of any opioid or sedative medications in the week

prior to surgery, a history of alcohol or drug abuse, known

allergy to any of the test drugs or contraindication to spinal

anesthesia (e.g., coagulation defects, infection at puncture

site, pre-existing neurological deficits in the lower

extremities), and cardiovascular, respiratory, neurological,

psychological, hepatic, or renal disease.

N total at baseline:

Intervention: 25

Control: 25

Placebo: 25

Important prognostic factors²:

Age, y mean:

I: 57 (9)

Control: 55 (6)

Placebo: 57 (5)

Groups comparable at baseline

An infusion of

dexmedetomidine 0.5 μg/kg.

An infusion of midazolam of

0.05 mg/kg.

Length of follow-up:

From start of procedure- 24hrs after the end of procedure.

Loss-to-follow-up:

I: Not reported

C: Not reported

Patient satisfaction

Defined as postoperative pain assessed by the patient using the visual analogue scale

(VAS; 0 = no pain; 10 = worst possible pain) over 24 hrs.. Results shown as a mean (SD).

I: 2.1 (0.6)

C: 2.8 (0.5)

Mean difference: -0.7 (95% CI, -1.01 to -0.39)

Provider satisfaction

Defined with a categorical scale from 1-3, where category 3 was highest satisfaction. Results shown as a median (range)

Highest satisfaction:

I: 3 (2-3)

C: 3 (2-3)

Sedation level

The Ramsay sedation score was used for sedation

score (1 = anxious and agitated; 2 = cooperative and

tranquil; 3 = drowsy but responsive to command; 4 =

asleep but responsive to a glabellar tap; 5 = asleep with a sluggish response to tactile stimulation; and 6 = asleep

and no response). The score was re-evaluated every 10 min for up to 120 min. Excessive sedation was defined as a score greater than 4/6 (but in the outcomes as greater than 5/6).

I: 2/25

C: 5/25

RR 0.40 (95% CI, 0.09-1.87)

Recovery time

Recovery time for sensory blockade was defined as two-dermatome regression of anesthesia from the maximum level. Motor block was assessed immediately after sensory block assessment using a Modified

Bromage Scale10 (0 = no paralysis; 1 = unable to raise

extended leg; 2 = unable to flex knee; 3 = unable to flex

ankle). Motor block duration was the time for return to

Modified Bromage Scale 1. Results shown as mean minutes  (SD).

I: 193 (27)

C: 186 (38)

Mean difference 7 (95% CI, -11.27 to 25.27)

Hypoxemia

defined as an Et-CO2 >50 mmHg or RR<12 breaths/min.

I: 0/25

C: 0/25

RR Not estimatable

Hypotension

A decrease in MAP below

20% of baseline or systolic pressure <90 mmHg

I: 2/25

C: 0/25

Remarks:

• The study is underpowered
• Prespecified outcomes

are sometimes reported as ‘non-significant’ thereby prohibiting a numerical evaluation.

• Definitions in the results section are sometimes different than as reported in the methods for undefined reasons

Authors conclusion:

‘intravenous dexmedetomidine given as premedication […] provided sedation and

additional analgesia.’

Mishina (2018)

Type of study:

RCT (single blind)

Setting and country:

Hospital; Japan

Funding and conflicts of interest:

The authors had no conflicts of interest to declare in relation to this article

patients with single-sided primary inguinal hernia, and

undergoing elective surgical repair using the tension-free

technique with local anesthesia.

Inclusion criteria:

• Patients aged 20-85
• ASA: Not reported

Exclusion criteria:

Excluded were those with a serious systemic complication, a mental or neurologic

disorder affecting the mental state, or a femoral hernia.

N total at baseline:

Intervention: 100

Control: 100

Important prognostic factors²:

Age, y mean (SD):

I: 67  (12)

C: 65 (12)

Sex: M/F

I:  98/1

C: 91/6

Groups comparable at baseline

Group D at a dose of 3 μg/kg/h for 10 min. Five minutes after the start of drug injection, we perform local anesthesia with surgical site and

ilioinguinal nerve block using a mixture of 0.5% lidocaine and 0.75% bupivacaine.

Period 3: Ten minutes after the start of drug injection,

the flow rate of dexmedetomidine is changed to 0.4 μg/kg/h

in Group D.

Period 4: operation started

Period 5: Spermatic cord is separated from inguinal canal.

(We always follow this procedure to avoid damage to the

cord.)

Period 6: Separation of the hernia sac and insertion of a

Plug or UHS.

Period 7: When suturing a Plug or fixing the UHS, we

request the patient to apply abdominal pressure.

Period 8: Suturing the fascia of external oblique. In

Group D, injection of dexmedetomidine is stopped. Surgery

is completed. During the operation, we could change

the flow rate of dexmedetomidine, using additional sedation

agent or injection of additional local anesthetic depending

on the needs of the patients.

Intravenous

midazolam 2 mg is administered in Group M slowly over

a period up to 1 min. Five minutes after the start of drug injection, we perform local anesthesia with surgical site and

ilioinguinal nerve block using a mixture of 0.5% lidocaine and 0.75% bupivacaine.

Period 3: Ten minutes after the start of drug injection,

the flow rate of dexmedetomidine is changed to 0.4 μg/kg/h

in Group D.

Period 4: operation started

Period 5: Spermatic cord is separated from inguinal canal.

(We always follow this procedure to avoid damage to the

cord.)

Period 6: Separation of the hernia sac and insertion of a

Plug or UHS.

Period 7: When suturing a Plug or fixing the UHS, we

request the patient to apply abdominal pressure.

Period 8: Suturing the fascia of external oblique. Surgery

is completed.

Length of follow-up:

From start of procedure-discharge.

Loss-to-follow-up:

I: 1/100

C: 3/100

Patient satisfaction

After the operation, we administered a questionnaire to the patients that elicited information about satisfaction.

I: Unclear

C:Unclear

Provider satisfaction

Operators completed

a questionnaire

I: Unclear

C: Unclear

Sedation level

Number of patients who were in a state of conscious sedation (OAA/S Scale: 3–4) during the procedure

I: 80/99

C: 72/97

RR 0.74 (95% CI, 0.44-1.26)

Recovery time

Not reported

Hypoxemia

Respiratory rate < 8 bpm, 25% decrease from before administration, SpO2

< 90%, decrease by 10% from before administration

or oxygen administration

I: 36/99

C: 50/97

Hypotension

systolic blood pressure < 80 mmHg, decrease by

30% from before administration or diastolic blood pressure

< 50 mmHg

I: 8/99

C: 2/97

Remarks:

• Patient and provider satisfaction are ill defined and could not be reported as an outcome here, as the numbers from the figures in the article were unreadable
• The study is single blind (blinded only to patients)
• No pre-published study protocol

Authors conclusion:

‘This study demonstrated that intravenous dexmedetomidine

during hernia repair with local anesthesia is safe.’

Darwish (2012)

Type of study:

Unclear (described as an RCT)

Setting and country:

Hospital; Egypt

Funding and conflicts of interest:

Unknown (The authors did not report if they had conflicts of interest to declare in relation to this article)

patients undergoing combined cataract and glaucoma surgery under peribulbar anesthesia

Inclusion criteria:

• Patients aged 40-60 years
• ASA: 1-3

Exclusion criteria:

Patients with high serum creatinine, advanced

liver disease, history of chronic use of sedatives,

narcotics or allergy to any of the study medications were excluded.

N total at baseline:

Intervention: 50

Control: 50

Important prognostic factors²:

Age, y mean (SD):

I: 50  (9)

C: 52 (10)

Sex: M/F

I:  30/20

C: 26/24

Groups comparable at baseline

i.v. dexmedetomidine infusion 0.2-0.5µg/kg/min without loading. The infusion rate was titrated every

3 min according to Richmond Agitation-Sedation Scale

(Table 1) (6) and a bispectral index between 80-70 %.

propofol 25-75µg/kg/min i.v. infusion. The infusion rate was titrated every

3 min according to Richmond Agitation-Sedation Scale

and a bispectral index between 80-70 %

Length of follow-up:

From start of procedure-discharge.

Loss-to-follow-up:

I: Unreported

C: Unreported

Patient satisfaction

Four hours after end of surgery, patients were asked to answer the question ‘How would you rate your experience with the

sedation you have received during surgery?’ using 7-

point like verbal rating scale (0 lowest satisfaction, 7, highest satisfaction). Results shown with mean (SD)

I: 6.53 (0.63)

C:5.39 (0.98)

Mean difference: -1.14 (95%, -1.46 to -1.92)

Provider satisfaction

Not reported

Sedation level

Sedation was titrated using

Richmond Agitation-Sedation Scale and bispectral index. The targeted level of adequate sedation level was provided as mean, minutes (SD), but was further undefined:

I: 15.36 (4.66)

C: 11.96 (3.27)

Mean difference 3.40 (95% CI, 1.82-4.98)

Recovery time

In the recovery room, Aldrete score  was determined every

5 min until. Patients were

deemed ready for discharge when they had achieved an

Aldrete score of 10. Reported as mean (SD)

I: 40.53 (6.51)

C: 37.60 (6.42)

Hypoxemia

Not reported

Hypotension

Not reported

Remarks:

• Definition of ‘adequate sedation level’ is undefined
• The study is described as an RCT, but how randomization was performed is not provided in the article
• No pre-published study protocol

Authors conclusion:

‘Compared with propofol, dexmedetomidine appears to be suitable for sedation in patients

undergoing cataract surgery.’

Dey (2009)

Type of study:

RCT

Setting and country:

Hospital; India

Funding and conflicts of interest:

The authors had no conflicts of interest to declare in relation to this article

Patients posted for elective surgery

under general anesthesia requiring intubation

Inclusion criteria:

• Patients aged 18-60 years
• ASA: 1-2

Exclusion criteria:

Patients with higher degree atrioventricular block, obstructive sleep apnea, and morbid obesity and those who are treated with angiotensin‑converting enzyme inhibitors, α2 antagonist, and long‑term use of benzodiazepines or tricyclic antidepressants

were excluded from the study.

N total at baseline:

Intervention: 45

Control: 45

Important prognostic factors²:

Age, y mean (SD):

I: 39  (9)

C: 37 (9)

Sex: M/F

I:  30/15

C: 35/10

Groups comparable at baseline

Patients were given dexmedetomidine

1 μg/kg bolus infusion over 15 min, followed by an infusion

of 0.2 μg/kg/h, which was then titrated up to 0.7 μg/kg/h until

they were adequately sedated as defined by BIS (60–70) and

Ramsay Sedation Scale(RSS ≥2).

Patients received

IV propofol, which was given 0.1 mg/kg/min bolus infusion,

followed by an infusion of propofol 0.025 mg/kg/min, which

was then titrated up to 0.075 mg/kg/min until they were

adequately sedated.

Length of follow-up:

From start of procedure-24 hrs postoperative.

Loss-to-follow-up:

I: Unreported

C: Unreported

Patient satisfaction

Defined by intubation comfort score in which no discomfort was shown at time of intubation

I: 24/45

C:20/45

RR 1.20 (95% CI, 0.78-1.84)

Provider satisfaction

Not reported

Sedation level

Sedation level was defined by

calculating rescue doses for maintaining the RSS ≥2

I:  Unreported

C: Unreported

Recovery time

Not reported

Hypoxemia

SpO2 of <90%

I: 3/45

C: 10/45

Hypotension

Not reported

Remarks:

• Sedation level is defined, but only reported as ‘not significant’, thereby making it not possible to perform a numerical analysis
• No pre-published study protocol

Authors conclusion:

‘IV dexmedetomidine can help in achieving better patient

tolerance and comfort for an anticipated difficult airway

where fiber‑optic intubation is indicated.’

Eberl (2016)

Type of study:

RCT

Setting and country:

Tertiary Care Hospital; The Netherlands

Funding and conflicts of interest:

The authors had no conflicts of interest to declare in relation to this article

Patients requiring endoscopic oesophageal

procedures for treatment of Barrett’s oesophagus under conscious sedation

Inclusion criteria:

• Adult patients
• ASA: 1-3

Exclusion criteria:

Exclusion criteria were known allergic

reaction to planned medication, SBP less than 80mmHg,

heart rate (HR) less than 50 bpm, ejection fraction less

than 30%, estimated glomerular filtration rate less than

15 ml/min or impaired liver function (Child–Pugh

Class A, B or C).

N total at baseline:

Intervention: 32

Control: 31

Important prognostic factors²:

Age, y, n:

I:

18-65:16

65:80:14

>80:1

C:

18-65: 12

65-80: 14

>80: 6

Sex: M/F

I:  28/3

C: 22/9

Groups comparable at baseline

dexmedetomidine

(Dexdor: Orion corporation, Finland). Owing to

the absence of precise pharmacokinetic/pharmacodynamic

models for a dexmedetomidine target controlled

infusion (TCI) system, we used the dosage recommended

by the American Food and Drug Administration

agency for bolus and continuous sedation with dexmedetomidine.

We started with a loading dose of intravenous

dexmedetomidine, 1mgkg1 over 10 min followed

by a maintenance infusion rate of 0.7 to 1umg/k/h

continued throughout the procedure. In patients aged

more than 65 years, the loading dose was reduced to

0.5 umg/kg.

routine

AMC sedation regimen using a propofol TCI system

(Propofol 1% MCT Fresenius, Germany), starting with

a targeted plasma concentration of 2.0umg/ml.

Length of follow-up:

From start of procedure-24 hrs postoperative.

Loss-to-follow-up:

I: 1/32

C: 0/31

Patient satisfaction

Patients were asked to rate their satisfaction

or dissatisfaction with the procedure ranging from 1=very dissatisfied to 7=highly satisfied. Result for global satisfaction shown as median (IQR)

I: 5.0 (4.4-5.8)

C: 6.0 (5.4-6.0)

P<0.001 (in advantage for propofol)

Provider satisfaction

Endoscopists were asked to rate their satisfaction

or dissatisfaction with the procedure ranging from 1=very dissatisfied to 7=highly satisfied. Result for global satisfaction shown as median (IQR)

I: 5.0 (3.75-5.75)

C: 6.25 (5.3-6.5)

P<0.001 (in advantage for propofol)

Sedation level

Not reported

Recovery time

Reported as median Aldrete score 30-60 minutes after the end of sedation.

I: unreadable from figure

C: unreadable from figure

‘significantly lower in group dexmedetomidine’

Hypoxemia

Not reported

Hypotension

Not reported

Remarks:

• Study protocol was prepublished
• Most outcomes only provided with a p-value, making it impossible to perform a quantitative analysis

Authors conclusion:

‘Compared with propofol, sedation with

dexmedetomidine resulted in less satisfaction, and caused prolonged haemodynamic depression after endoscopic

oesophageal procedures.’

Alizadehasl (2019)

Type of study:

RCT

Setting and country:

Hospital; Iran

Funding and conflicts of interest:

The authors had no conflicts of interest to declare in relation to this article

Cardiac patients, who underwent TEE in a referral heart hospital

Inclusion criteria:

• Adult patients aged 18-70 yrs
• ASA: 2-4

Exclusion criteria:

exclusion

criteria comprised heart failure (left ventricular ejection

fraction ≤30), severe obstructive valvular lesions of heart,

allergy to Dex or propofol, contraindication to TEE, severe

neurological or mental disorder, heart rate ≤60 bpm, and

tracheal intubation

N total at baseline:

Intervention: 34

Control: 31

Important prognostic factors²:

Age, y, mean (SD):

I: 42 (16)

C: 45 (15)

Sex: M/F

I:  14/17

C: 14/20

Groups comparable at baseline

In the Dex group, the loading dose of Dex (1 μg/kg) was

infused over 10 min. After a Ramsay sedation score

of 3 was obtained, the TEE probe was inserted, and

the echocardiography examination was initiated. The

maintenance dose of Dex was 0.1–0.5 μg/kg/h and the

patients’ sedation level was evaluated at 5‑min intervals.

When the Ramsay score dropped below 3, 20% was

added to the maintenance dose of Dex.

In the propofol

group, an initial dose of 0.1 mg/kg was administered,

and when a Ramsay score of 3 was obtained, the TEE

examination was performed. The maintenance dose of

propofol was 25–75 μg/kg/min, and it was adjusted

according to the patients’ sedation level, as was the case

in the Dex group.

Length of follow-up:

From start of procedure-discharge.

Loss-to-follow-up:

I: 0/34

C: 3/34

Patient satisfaction

General satisfaction rate from bad (grade 0)

to perfect (grade 4). Perfect score reported

I: 26/34

C: 27/31

RR: 0.88 (95% CI, 0.70-1.11)

Provider satisfaction

General satisfaction rate from bad (grade 0)

to perfect (grade 4) in view of the anesthesiologist. Perfect score reported

I: 30/34

C: 26/31

RR 1.05 (95% CI, 0.86-1.28)

Sedation level

Time from start sedation to TEE, min, meqn (SD)

I: 12.6 (3.2)

C: 2.8 (0.8)

Mean difference 9.80 (95% CI, 8.69-10.91)

Recovery time

Defined as ‘full recovery from sedation’, mean (SD).

I: 3.0 (0.8)

C: 5.5 (3.1)

Mean difference -2.50 (95% CI, -3.62 to -1.38)

Hypoxemia

SpO2 <90%

I: 0/34

C: 2/31

Hypotension

systolic blood pressure <90 mm Hg

I: 1/34

C: 0/31

Remarks:

• Study protocol was pre-published
• Study was underpowered to assess safety between the 2 treatments
• Outcome ‘recovery time’ is ill defined

Authors conclusion:

‘Time from the beginning of

sedation with Dex was longer than that with propofol. However, Dex was able to provide satisfactory

sedation levels, hemodynamic stability, short recovery time, and acceptable patient and practitioner

satisfaction during TEE in our cardiac patients.’

Ter Bruggen (2019)

Type of study:

RCT

Setting and country:

Tertiary Care Center; The Netherlands

Funding and conflicts of interest:

The study was funded by

institutional sources and a grant (16‐1444) from the "Stichting Erasmus

Fonds Pijnbestrijding" based in Rotterdam,

the Netherlands.

The authors had no conflicts of interest to declare in relation to this article

consecutive patients

with an indication for implantation of a

neurostimulator.

Inclusion criteria:

• Adult aged 18-65 yrs
• ASA: Not provided

Exclusion criteria:

Exclusion criteria were hypersensitivity to either

of the drugs investigated, atrioventricular block (II‐III), acute cerebrovascular

disease, HR ≤ 60 bpm, pregnancy, recent acute epilepsy

or uncontrolled seizure, severe liver dysfunction, use of beta blocking

agents, psychopathology, or a communication problem.

N total at baseline:

Intervention: 35

Control: 34

Important prognostic factors²:

Age, y, median (IQR):

I: 47 (41-53)

C: 46  (37-56)

Sex: M/F

I:  12/23

C: 9/25

Groups comparable at baseline

dexmedetomidine

(1 μg/kg for 10 minutes, followed by 0.6 μg/kg/h)

propofol (0.5 mg/kg for 10 minutes, followed by 2.0 mg/kg/h)

Length of follow-up:

From start of procedure-post‐operatively on the ward.

Loss-to-follow-up:

I: 1/36

C: 2/36

Patient satisfaction

The primary outcome parameter was patient satisfaction with the

sedation, measured with the Patient Satisfaction with Sedation

Index (PSSI). The PSSI consists of 4

subscales, i.e. sedation delivery (2 items), procedural recall (4 items),

sedation side‐effects (10 items), and global satisfaction (4 items).

Subscale scores can range from 0 to 100, with higher scores indicating

higher patient satisfaction. Result for global satisfaction shown with median (IQR)

I: 94.4 [100.0‐88.9]

C: 88.9 [100.0‐83.3]

P=0.17

Of note, other patient satisfaction outcomes, including

Sedation delivery,

Procedural recall and

Sedation side‐effects were ‘significant’ (in favor for dexmetomidine)

Provider satisfaction

Defined as operator's

comfort throughout the procedure, measured as the response

to the question "What score would you give to the comfort during

the procedure?" — from 1 (bad) till 4 (excellent). Result shown as median

IQR

I: 3.00 [IQR 1.0]

C: 3.00 [IQR 0.63]

P=0.50

Sedation level

A rescue bolus of remifentanil 25 μg was given if a patient

reported a high level of pain. Total number of participants who received 1 or more rescue bolus shown

I: 19/35

C: 21/34

RR 0.88 (95% CI 0.59-1.32)

Recovery time

Not reported

Hypoxemia

SpO2 < 90% during the procedure

I: 2/35

C: 4/34

Hypotension

Mean arterial pressure < 60 mm Hg

I: 2/35

C: 1/34

Remarks:

• The trial is single blinded
• Protocol pre-published
•  Powered for primary outcome (patient satisfaction)
• No SD provided for continues outcomes, making it not possible to calculate 95% CI’s (results are shown with P-value)
• Some of the outcomes were not defined in the methods (only defined in the results)
• Trial not powered for other outcomes

Authors conclusion:

‘Dexmedetomidine sedation resulted in higher patient satisfaction and

allowed for better arousable sedation than sedation with propofol. Although differences

in hemodynamic parameters were found between the groups, these differences were not regarded as clinically relevant.’