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Dexmedetomidine Versus Propofol in Vitreoretinal Surgery

Primary Purpose

Retinal Detachment

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine infusion
propofol
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Detachment focused on measuring sedation for vitreoretinal surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMDNJ-University Hospital
  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Propofol

dexmedetomidine infusion

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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 Hemodynamic Stability
systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm
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 Heart Rate Stability
Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm

Secondary Outcome Measures

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.
Surgeon Satisfaction for Adequate Sedation
1=very poor, 2=poor,3=fair, 4=good, 5=excellent
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
Patient Satisfaction
1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent
Post Operative Hemodynamic Stability
blood pressure documented at 30 minute intervals in PACU up to 120 min
Hemodynamic Stability Post Operatively in PACU
heart rate recorded at 30 min intervals in PACU up to 120 min

Full Information

First Posted
October 22, 2009
Last Updated
July 18, 2017
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT01001429
Brief Title
Dexmedetomidine Versus Propofol in Vitreoretinal Surgery
Official Title
Comparison of Dexmedetomidine vs. Propofol in Vitreoretinal Surgery Under Sub-Tenon's Block
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Adequate sedation Hemodynamic and respiratory stability intraoperatively Secondary: surgeon satisfaction Time to achieved " street fitness " status subject satisfaction Hemodynamic stability in PACU

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
sedation for vitreoretinal surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min
Arm Title
dexmedetomidine infusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine infusion
Other Intervention Name(s)
Precedex infusion
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
Diprivan
Intervention Description
propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min
Primary Outcome Measure Information:
Title
Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS)
Description
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
Title
Intraoperative Hemodynamic Stability
Description
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
Title
Intraoperative Respiratory Stability
Description
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
Title
Intraoperative Heart Rate Stability
Description
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
Secondary Outcome Measure Information:
Title
Time to Achieve "Street Fitness"
Description
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
Title
Surgeon Satisfaction for Adequate Sedation
Description
1=very poor, 2=poor,3=fair, 4=good, 5=excellent
Time Frame
at 10 minutes into the procedure
Title
Surgeon Satisfaction for Adequate Sedation at Completion of Procedure
Description
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
Title
Patient Satisfaction
Description
1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent
Time Frame
measured prior to discharge up to 2 hours
Title
Post Operative Hemodynamic Stability
Description
blood pressure documented at 30 minute intervals in PACU up to 120 min
Time Frame
2 hours in PACU
Title
Hemodynamic Stability Post Operatively in PACU
Description
heart rate recorded at 30 min intervals in PACU up to 120 min
Time Frame
PACU to 2 hours post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anuradha Patel, MD
Organizational Affiliation
Rutgers /NJMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMDNJ-University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dexmedetomidine Versus Propofol in Vitreoretinal Surgery

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