Dexmedetomidine vs. Propofol for Cataract Surgery

Cataract Clinical Trial

Official title:

Dexmedetomidine vs. Propofol for Monitored Anesthesia Care During Cataract

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786370
• Other study ID #: RP 08-045
• Status: Completed
• Phase: Phase 4
• First received: November 5, 2008
• Last updated: February 9, 2012
• Start date: April 2008
• Est. completion date: April 2010

Study information

• Verified date: November 2008
• Source: The Cooper Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery.		1 day	Yes