Dexmedetomidine Versus Propofol in Vitreoretinal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Retinal Detachment
• Intervention / Treatment: Drug: propofol; Drug: Dexmedetomidine infusion

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

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07102
      • UMDNJ-University Hospital
    • Newark, New Jersey, United States, 07102
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Propofol; propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min	Drug: propofol; propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min; Other Names: Diprivan
Experimental: 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.	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; Other Names: Precedex infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative up to 120 min
Intraoperative Hemodynamic Stability	systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm	Intraoperative up to 120 min
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	Intraoperative up to 120 min
Intraoperative Heart Rate Stability	Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm	Intraoperative up to 120 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	for 2 hours post-operatively in Post Anesthesia Care unit
Surgeon Satisfaction for Adequate Sedation	1=very poor, 2=poor,3=fair, 4=good, 5=excellent	at 10 minutes into the procedure
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	immediately following the completion of the procedure up to one hour
Patient Satisfaction	1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent	measured prior to discharge up to 2 hours
Post Operative Hemodynamic Stability	blood pressure documented at 30 minute intervals in PACU up to 120 min	2 hours in PACU
Hemodynamic Stability Post Operatively in PACU	heart rate recorded at 30 min intervals in PACU up to 120 min	PACU to 2 hours post op

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Anuradha Patel, MD, Rutgers /NJMS

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 22, 2009
• First Submitted That Met QC Criteria: October 23, 2009
• First Posted (Estimate): October 26, 2009

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: sedation for vitreoretinal surgery
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: 0120090202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO