Dexmedetomidine vs. Propofol for Cataract Surgery - Full Text View

Sponsored by:	Cooper University Hospital
Information provided by:	Cooper University Hospital
ClinicalTrials.gov Identifier:	NCT00786370

Purpose

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.

Condition	Intervention	Phase
Cataract	Drug: dexmedetomidine Drug: Propofol Drug: Dexemedetomidine	Phase IV

MedlinePlus related topics: Anesthesia Cataract

Drug Information available for: Fentanyl Citrate Fentanyl Midazolam Midazolam hydrochloride Midazolam maleate Propofol Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Dexmedetomidine vs. Propofol for Monitored Anesthesia Care During Cataract

Further study details as provided by Cooper University Hospital:

Primary Outcome Measures:

To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	April 2008
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Propofol: Active Comparator	Drug: Propofol continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved
Dexmedetomidine: Experimental	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. Drug: 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.

Arms

Assigned Interventions

Propofol: Active Comparator

Drug: Propofol

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

Dexmedetomidine: Experimental

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.

Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786370

Contacts

Contact: Jeffrey Littman, MD	856-968-7333	Littman-Jeffrey@cooperhealth.edu
Contact: Marc Torjman, PhD	856-757-7814	Torjmamc@umdnj.edu

Locations

United States, New Jersey
Cooper University Hospital	Recruiting
Camden, New Jersey, United States, 08103
Contact: Ashley Shapiro, BA 856-968-7333 Shapiro-Ashley@cooperhealth.edu
Contact: Marc Torjman, PhD 856-757-7814 Torjmamc@umdnj.edu
Sub-Investigator: Marc Torjman, PhD

Sponsors and Collaborators

Cooper University Hospital

Investigators

Principal Investigator:

Jeffrey Littman, MD

The Cooper Health System

More Information

Responsible Party:	Cooper University Hospital ( Jeffrey Littman, MD )
Study ID Numbers:	RP 08-045
Study First Received:	November 5, 2008
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00786370
Health Authority:	United States: Institutional Review Board

Keywords provided by Cooper University Hospital:

propofol
dexmedetomidine
cataract

respiratory
blood pressure
Cataract surgery

Study placed in the following topic categories:

Fentanyl
Eye Diseases
Cataract
Lens Diseases

Dexmedetomidine
Propofol
Midazolam

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Adrenergic Agonists

Pharmacologic Actions
Anesthetics, General
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009