We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dexmedetomidine Versus Propofol in Vitreoretinal Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01001429
First Posted: October 26, 2009
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
October 22, 2009
October 26, 2009
February 11, 2016
August 21, 2017
August 21, 2017
October 2009
March 2013   (Final data collection date for primary outcome measure)
  • Adequate Sedation Via Bispectral Index Score (BIS)and University of Michigan Sedation Scale (UMSS) [ Time Frame: Intraoperative up to 120 min ]
    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 [ Time Frame: Intraoperative up to 120 min ]
    systolic and diastolic blood pressure was recorded at 5 minute intervals up to 120 min and were averaged per study arm
  • Intraoperative Respiratory Stability [ Time Frame: Intraoperative up to 120 min ]
    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 [ Time Frame: Intraoperative up to 120 min ]
    Heart rate recorded at 5 minute intervals during surgery up to 120 min and averaged per study arm
adequate sedation via Bispectral Index Score and University of Michigan Sedation Scale [ Time Frame: during operative procedure ]
Complete list of historical versions of study NCT01001429 on ClinicalTrials.gov Archive Site
  • Time to Achieve "Street Fitness" [ Time Frame: for 2 hours post-operatively in Post Anesthesia Care unit ]
    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 [ Time Frame: at 10 minutes into the procedure ]
    1=very poor, 2=poor,3=fair, 4=good, 5=excellent
  • Surgeon Satisfaction for Adequate Sedation at Completion of Procedure [ Time Frame: immediately following the completion of the procedure up to one hour ]
    surgeon satisfaction graded on numerical scale 1=very poor. 2=poor, 3=fair 4=good, 5=excellent
  • Patient Satisfaction [ Time Frame: measured prior to discharge up to 2 hours ]
    1=very poor, 2=poor, 3=fair, 4=very good, 5=excellent
  • Post Operative Hemodynamic Stability [ Time Frame: 2 hours in PACU ]
    blood pressure documented at 30 minute intervals in PACU up to 120 min
  • Hemodynamic Stability Post Operatively in PACU [ Time Frame: PACU to 2 hours post op ]
    heart rate recorded at 30 min intervals in PACU up to 120 min
post-operative pain score [ Time Frame: for 2 hours post-operatively in Post Anesthesia Care unit ]
Not Provided
Not Provided
 
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.

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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Retinal Detachment
  • 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 Name: Precedex infusion
  • Drug: propofol
    propofol 1mg/kg intravenously as a bolus followed by 25-100ug/kg/min
    Other Name: Diprivan
  • Active Comparator: Propofol
    propofol 1mg/kg as a bolus intravenously followed by an infusion of 25-100 ug/kg/min
    Intervention: Drug: propofol
  • 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.
    Intervention: Drug: Dexmedetomidine infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
November 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01001429
0120090202
No
Not Provided
Plan to Share IPD: No
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
Not Provided
Principal Investigator: Anuradha Patel, MD Rutgers /NJMS
Rutgers, The State University of New Jersey
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP