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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
  Purpose
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.

Condition Intervention Phase
Retinal Detachment Drug: Dexmedetomidine infusion Drug: propofol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Dexmedetomidine vs. Propofol in Vitreoretinal Surgery Under Sub-Tenon's Block

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 78
Study Start Date: October 2009
Study Completion Date: November 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Precedex 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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001429


Locations
United States, New Jersey
UMDNJ-University Hospital
Newark, New Jersey, United States, 07102
University Hospital
Newark, New Jersey, United States, 07102
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Anuradha Patel, MD Rutgers /NJMS
  More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01001429     History of Changes
Other Study ID Numbers: 0120090202
First Submitted: October 22, 2009
First Posted: October 26, 2009
Results First Submitted: February 11, 2016
Results First Posted: August 21, 2017
Last Update Posted: August 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rutgers, The State University of New Jersey:
sedation for vitreoretinal surgery

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases
Propofol
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action