Dexmedetomidine vs. Propofol for Cataract Surgery

Sponsor

The Cooper Health System (Other)

Overall Status

Completed

CT.gov ID

NCT00786370

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: dexmedetomidine Drug: Propofol Drug: Dexemedetomidine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Dexmedetomidine vs. Propofol for Monitored Anesthesia Care During Cataract

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Propofol	Drug: Propofol continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved
Experimental: Dexmedetomidine	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: 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.

Arm

Intervention/Treatment

Active Comparator: Propofol

Drug: Propofol

continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved

Experimental: Dexmedetomidine

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: 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.

Outcome Measures

Primary Outcome Measures

To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery. [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Liver disease (Child Pugh classification 1-3)
History of chronic use of sedatives, narcotics, alcohol or illicit drugs or allergy to any the study medications
History of 1st and 2nd degree heart block (not paced)
Any patient with EF < 30%
Patients with active seizure history
Pregnant patients (women of child bearing potential will have a preoperative pregnancy test as is standard of practice)