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Dexmedetomidine vs. Propofol for Cataract Surgery

This study has been completed.
Sponsor:
Information provided by:
Cooper University Hospital
ClinicalTrials.gov Identifier:
NCT00786370
First received: November 5, 2008
Last updated: February 9, 2012
Last verified: November 2008
History of Changes

November 5, 2008
February 9, 2012
April 2008
April 2010   (final data collection date for primary outcome measure)
To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00786370 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Dexmedetomidine vs. Propofol for Cataract Surgery
Dexmedetomidine vs. Propofol for Monitored Anesthesia Care During Cataract

The use of dexmedetomidine in cataract surgery is still limited and to date only one study has examined anesthetic technique in this patient population. This pilot study will therefore compare the use of dexmedetomidine and propofol in subjects undergoing cataract surgery. The primary endpoint will be based on simple cardiorespiratory measures often associated with complications from sedation as well as assessment of the achieved sedation by the attending anesthesiologist and surgeon.
 
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Cataract
  • Drug: dexmedetomidine
    Propofol or dexmedetomidine infusion will be started according to the randomized treatment allocation. The propofol group will receive a bolus of 2mg midazolam and 100mcg fentanyl and then continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved. The dexmedetomidine group will receive a bolus of dexmedetomidine 1mcg/kg for 10 minutes and then a continuous infusion of dexmedetomidine 0.2-0.7mcg/kg/hr until a Ramsay score of 3 or a Bis score of 60-80 are achieved.
  • Drug: Propofol
    continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved
  • Drug: Dexemedetomidine
    continuous infusion of dexmedetomidine 0.2-0.7mcg/kg/hr until a Ramsay score of 3 or a Bis score of 60-80 are achieved.
  • Active Comparator: Propofol
    Intervention: Drug: Propofol
  • Experimental: Dexmedetomidine
    Interventions:
    • Drug: dexmedetomidine
    • Drug: Dexemedetomidine
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Normal renal function
  2. No chronic use of narcotics
  3. ASA PS1-3
  4. Males or females age 18 or older

Exclusion Criteria:

  1. Liver disease (Child Pugh classification 1-3)
  2. History of chronic use of sedatives, narcotics, alcohol or illicit drugs or allergy to any the study medications
  3. History of 1st and 2nd degree heart block (not paced)
  4. Any patient with EF < 30%
  5. Patients with active seizure history
  6. Pregnant patients (women of child bearing potential will have a preoperative pregnancy test as is standard of practice)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00786370
RP 08-045
No
Jeffrey Littman, MD, Cooper University Hospital
Cooper University Hospital
 
Principal Investigator: Jeffrey Littman, MD The Cooper Health System
Cooper University Hospital
November 2008

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