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Dexmedetomidine vs. Propofol for Cataract Surgery

Information source: The Cooper Health System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: dexmedetomidine (Drug); Propofol (Drug); Dexemedetomidine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: The Cooper Health System

Official(s) and/or principal investigator(s):
Jeffrey Littman, MD, Principal Investigator, Affiliation: The Cooper Health System

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.

Clinical Details

Official title: Dexmedetomidine vs. Propofol for Monitored Anesthesia Care During Cataract

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

Primary outcome: To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Cooper University Hospital, Camden, New Jersey 08103, United States
Additional Information

Starting date: April 2008
Last updated: February 9, 2012

Page last updated: August 23, 2015

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