Dexmedetomidine Versus Propofol in Vitreoretinal Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01001429
First received: October 22, 2009
Last updated: April 3, 2014
Last verified: April 2014
  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
Ambulatory Surgery
Drug: Dexmedetomidine infusion
Drug: propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 and University of Michigan Sedation Scale [ Time Frame: during operative procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • time to achieve "street fitness" [ Time Frame: for 2 hours post-operatively in Post Anesthesia Care unit ] [ Designated as safety issue: No ]
    Subjects will be kept in the 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.


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 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

Secondary:

  1. surgeon and subject satisfaction
  2. Incidence of nausea and vomiting
  3. Time to achieved " street fitness " status
  4. Post op hemodynamic stability
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001429

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

No publications provided

Responsible Party: Anesthesia, Department of Anesthesia/Investigator initiated, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01001429     History of Changes
Other Study ID Numbers: 0120090202
Study First Received: October 22, 2009
Last Updated: April 3, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Propofol
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on August 20, 2014