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Dexmedetomidine vs. Propofol for Cataract Surgery

Primary Purpose

Cataract

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
dexmedetomidine
Propofol
Dexemedetomidine
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring propofol, dexmedetomidine, cataract, respiratory, blood pressure, Cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cooper University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Propofol

Dexmedetomidine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 5, 2008
Last Updated
February 9, 2012
Sponsor
The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT00786370
Brief Title
Dexmedetomidine vs. Propofol for Cataract Surgery
Official Title
Dexmedetomidine vs. Propofol for Monitored Anesthesia Care During Cataract
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Cooper Health System

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
propofol, dexmedetomidine, cataract, respiratory, blood pressure, Cataract surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Title
Dexmedetomidine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved
Intervention Type
Drug
Intervention Name(s)
Dexemedetomidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Littman, MD
Organizational Affiliation
The Cooper Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States

12. IPD Sharing Statement

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Dexmedetomidine vs. Propofol for Cataract Surgery

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