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Dexmedetomidine Versus Propofol in Vitreoretinal Surgery

Comparison of Dexmedetomidine vs. Propofol in Vitreoretinal Surgery Under Sub-Tenon's Block

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01001429
Enrollment
78
Registered
2009-10-26
Start date
2009-10-31
Completion date
2013-11-30
Last updated
2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

Keywords

sedation for vitreoretinal surgery

Brief summary

The investigators would like to determine if using Dexmedetomidine alone or in a reduced dose can prevent or reduce the incidence of adverse effects, while providing adequate sedation, and respiratory stability as compared to propofol.

Detailed description

Alpha2 adrenergic receptor agonist have been used increasingly as a new armamentarium to provide sedative/hypnotic, analgesic, anxiolytic and sympatholytic effects in the perioperative settings. Dexmedetomidine, a selective and specific alpha2- adrenoceptor agonist has unique properties that makes it an almost ideal sedative drug for monitored anesthesia care in procedures under local or regional block. Unlike other drugs use for sedation, dexmedetomidine induces sedation that is similar to natural sleep (readily arousable) without causing respiratory depression. It attenuates the stress-induced sympathoadrenal response seen with laryngoscopy and intubation. It has anesthetic and opioid sparing effects, hence it may be a useful adjunct to general anesthesia and monitored anesthesia care in patients susceptible to narcotic induced respiratory depression. Another unique property of dexmedetomidine is that its sedative effect is reversible with Atipamezole. A previous study wherein dexmedetomidine has been used in procedures under local and regional block had shown that it provides effective sedation and better operating condition without significant respiratory depression. As a supplement to general anesthesia, it has been shown to provide stable hemodynamics. However, it is associated with some adverse events such as hypertension, hypotension and bradycardia, these commonly occur during bolus administration of the recommended dose of 1ug/kg. Post-operatively it can cause nausea and vomiting. Vitreoretinal surgery requires either an injection of local anesthetic within the muscle cone (retrobulbar block),or into the periorbital space (peribulbar block). This can be done individually or in combination. This surgery can also be done under a safer technique of retrobulbar block that is given using a sub-tenon's approach through a snip peritomy; a blunt cannula can be used with this technique mitigating the complications of retrobulbar hemorrhage or inadvertent injection into the optic nerve sheath or perforation of the globe using a sharp needle. The anesthetic goal is to provide an immobile and uncongested operative field. Hemodynamic stability of the patient is also important since some patients that require this procedure are elderly with co-morbid conditions such as hypertension, diabetes mellitus and Coronary Artery Disease (CAD). In our study we would like to investigate if Dexmedetomidine alone and in a reduced dose can prevent or reduce the incidence of adverse effects, provide hemodynamic and respiratory stability, provide adequate sedation with patient and surgeon satisfaction and compare it with Propofol. Objectives: Primary: 1. Adequate sedation 2. Hemodynamic and respiratory stability intraoperatively Secondary: 1. surgeon satisfaction 2. Time to achieved street fitness status 3. subject satisfaction 4. Hemodynamic stability in PACU

Interventions

DRUGDexmedetomidine infusion

bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug

DRUGpropofol

propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min

Sponsors

Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists rating of I-III * good renal and liver function

Exclusion criteria

* renal and hepatic insufficiency * uncontrolled diabetes * uncontrolled hypertension * severe cardiac disease Class III or IV * heart blocks * chronic use of sedatives, narcotics, alcohol or illicit drugs * allergy to either propofol or dexmedetomidine * pregnancy or inability to tolerate technique of the study drugs

Design outcomes

Primary

MeasureTime frameDescription
Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)Intraoperative up to 120 minBispectral Index Score measurement uses processed electroencephalogram signals to measure sedation depth of a scale from 0-100 (0=coma; 40-60=general anesthesia;60-90 sedated;100=awake) University of Michigan Sedation Scale (1-4) is an observational scale that quantifies sedation.1=normal response to verbal stimuli, 2=conscious sedation, responsive to tactile stimuli, 3= deeply sedated responsive to repeated or painful stimuli, 4=general anesthesia: not arousable.
Intraoperative Hemodynamic StabilityIntraoperative up to 120 minsystolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm
Intraoperative Respiratory StabilityIntraoperative up to 120 minrespiratory rate data were recorded at 5 minutes intervals throughout the surgical procedure up to 120 mins for both groups and averaged per study arm
Intraoperative Heart Rate StabilityIntraoperative up to 120 minHeart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm

Secondary

MeasureTime frameDescription
Post Operative Hemodynamic Stability2 hours in PACUblood pressure documented at 30 minute intervals in PACU up to 120 min
Time to Achieve Street Fitnessfor 2 hours post-operatively in Post Anesthesia Care unitSubjects will be kept in the Post Anesthesia Care Unit (PACU) for a period of 2 hours. However it will be documented as to when, in the opinion of the PACU staff, the subject has met the criteria for discharge.
Hemodynamic Stability Post Operatively in PACUPACU to 2 hours post opheart rate recorded at 30 min intervals in PACU up to 120 min
Surgeon Satisfaction for Adequate Sedationat 10 minutes into the procedure1=very poor, 2=poor,3=fair, 4=good, 5=excellent
Surgeon Satisfaction for Adequate Sedation at Completion of Procedureimmediately following the completion of the procedure up to one hoursurgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent
Patient Satisfactionmeasured prior to discharge up to 2 hours1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent

Countries

United States

Participant flow

Recruitment details

Subjects were recruited the morning of surgery in the Same Day Surgery Suite

Pre-assignment details

One subject withdrew consent prior to group assignment. One subject surgery was cancelled

Participants by arm

ArmCount
Propofol
propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min propofol: propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min
39
Dexmedetomidine Infusion
Subject will receive a bolus of0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug. Dexmedetomidine infusion: bolus of 0.5ug/kg intravenously over a period of 10-15 minutes, followed by an infusion of 0.2-0.7ug/kg/hr of drug
37
Total76

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studysurgery cancelled01

Baseline characteristics

CharacteristicPropofolDexmedetomidine InfusionTotal
Age, Continuous40 years52 years46 years
Sex: Female, Male
Female
11 Participants12 Participants23 Participants
Sex: Female, Male
Male
28 Participants25 Participants53 Participants
total participants39 participants37 participants76 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 390 / 37
serious
Total, serious adverse events
0 / 391 / 37

Outcome results

Primary

Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)

Bispectral Index Score measurement uses processed electroencephalogram signals to measure sedation depth of a scale from 0-100 (0=coma; 40-60=general anesthesia;60-90 sedated;100=awake) University of Michigan Sedation Scale (1-4) is an observational scale that quantifies sedation.1=normal response to verbal stimuli, 2=conscious sedation, responsive to tactile stimuli, 3= deeply sedated responsive to repeated or painful stimuli, 4=general anesthesia: not arousable.

Time frame: Intraoperative up to 120 min

ArmMeasureValue (MEAN)
BIS Scores in Propofol Infusion GroupAdequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)84.8 units on a scale
BIS Scores in Dexmedetomidine Infusion GroupAdequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)88 units on a scale
UMSS Scores in Propofol Infusion GroupAdequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS).90 units on a scale
UMSS in Dexmedetomidine Infusion GroupAdequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS).94 units on a scale
p-value: 0.04Regression, Logistic
Comparison: UMSS scores with subjects propofol vs. Dexmetomidine groupp-value: 0.68Regression, Linear
Primary

Intraoperative Heart Rate Stability

Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm

Time frame: Intraoperative up to 120 min

ArmMeasureValue (MEAN)
BIS Scores in Propofol Infusion GroupIntraoperative Heart Rate Stability71 beats per minute
BIS Scores in Dexmedetomidine Infusion GroupIntraoperative Heart Rate Stability64 beats per minute
Primary

Intraoperative Hemodynamic Stability

systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm

Time frame: Intraoperative up to 120 min

ArmMeasureValue (MEAN)
BIS Scores in Propofol Infusion GroupIntraoperative Hemodynamic Stability124.9 mm/Hg
BIS Scores in Dexmedetomidine Infusion GroupIntraoperative Hemodynamic Stability114.6 mm/Hg
UMSS Scores in Propofol Infusion GroupIntraoperative Hemodynamic Stability73.6 mm/Hg
UMSS in Dexmedetomidine Infusion GroupIntraoperative Hemodynamic Stability66.2 mm/Hg
Primary

Intraoperative Respiratory Stability

respiratory rate data were recorded at 5 minutes intervals throughout the surgical procedure up to 120 mins for both groups and averaged per study arm

Time frame: Intraoperative up to 120 min

ArmMeasureValue (MEAN)
BIS Scores in Propofol Infusion GroupIntraoperative Respiratory Stability17 breaths per minute
BIS Scores in Dexmedetomidine Infusion GroupIntraoperative Respiratory Stability12 breaths per minute
Secondary

Hemodynamic Stability Post Operatively in PACU

heart rate recorded at 30 min intervals in PACU up to 120 min

Time frame: PACU to 2 hours post op

ArmMeasureValue (MEAN)
BIS Scores in Propofol Infusion GroupHemodynamic Stability Post Operatively in PACU74.1 beats per minute
BIS Scores in Dexmedetomidine Infusion GroupHemodynamic Stability Post Operatively in PACU72 beats per minute
Secondary

Patient Satisfaction

1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent

Time frame: measured prior to discharge up to 2 hours

ArmMeasureValue (MEAN)
BIS Scores in Propofol Infusion GroupPatient Satisfaction4.61 units on a scale
BIS Scores in Dexmedetomidine Infusion GroupPatient Satisfaction4.43 units on a scale
Secondary

Post Operative Hemodynamic Stability

blood pressure documented at 30 minute intervals in PACU up to 120 min

Time frame: 2 hours in PACU

ArmMeasureValue (MEAN)
BIS Scores in Propofol Infusion GroupPost Operative Hemodynamic Stability124.9 mmHg
BIS Scores in Dexmedetomidine Infusion GroupPost Operative Hemodynamic Stability114.6 mmHg
UMSS Scores in Propofol Infusion GroupPost Operative Hemodynamic Stability73.6 mmHg
UMSS in Dexmedetomidine Infusion GroupPost Operative Hemodynamic Stability66.2 mmHg
Secondary

Surgeon Satisfaction for Adequate Sedation

1=very poor, 2=poor,3=fair, 4=good, 5=excellent

Time frame: at 10 minutes into the procedure

ArmMeasureValue (MEAN)
BIS Scores in Propofol Infusion GroupSurgeon Satisfaction for Adequate Sedation4.62 units on a scale
BIS Scores in Dexmedetomidine Infusion GroupSurgeon Satisfaction for Adequate Sedation4.97 units on a scale
Secondary

Surgeon Satisfaction for Adequate Sedation at Completion of Procedure

surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent

Time frame: immediately following the completion of the procedure up to one hour

ArmMeasureValue (MEAN)
BIS Scores in Propofol Infusion GroupSurgeon Satisfaction for Adequate Sedation at Completion of Procedure4.77 units on a scale
BIS Scores in Dexmedetomidine Infusion GroupSurgeon Satisfaction for Adequate Sedation at Completion of Procedure4.89 units on a scale
Secondary

Time to Achieve Street Fitness

Subjects will be kept in the Post Anesthesia Care Unit (PACU) for a period of 2 hours. However it will be documented as to when, in the opinion of the PACU staff, the subject has met the criteria for discharge.

Time frame: for 2 hours post-operatively in Post Anesthesia Care unit

Population: Subjects meet criteria for discharge based upon the assessment from a professional independent of the study

ArmMeasureValue (MEAN)
BIS Scores in Propofol Infusion GroupTime to Achieve Street Fitness81 minutes
BIS Scores in Dexmedetomidine Infusion GroupTime to Achieve Street Fitness85 minutes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026