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
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