Dexmedetomidine vs. Propofol for Cataract Surgery

Phase 4

Completed

• Conditions: Cataract
• Interventions: Drug: Propofol; Drug: dexmedetomidine; Drug: Dexemedetomidine

• Registration Number: NCT00786370
• Lead Sponsor: The Cooper Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Status Verified: 2008-11
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2012-02-09
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	-
Dexmedetomidine	Dexemedetomidine	-
Dexmedetomidine	dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery.	1 day

Trial Locations

Locations (1)

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States