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

October 22, 2009
April 3, 2014
October 2009
March 2013   (final data collection date for primary outcome measure)
adequate sedation via Bispectral Index Score and University of Michigan Sedation Scale [ Time Frame: during operative procedure ] [ Designated as safety issue: Yes ]
Same as current
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 ] [ 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.
post-operative pain score [ Time Frame: for 2 hours post-operatively in Post anesthesia Care unit ] [ Designated as safety issue: No ]
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 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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Ambulatory Surgery
  • 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:

  • 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01001429
0120090202
No
Anesthesia, 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 2014

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