Dexmedetomidine vs. Propofol for Cataract Surgery - Full Text View

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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Dexmedetomidine vs. Propofol for Monitored Anesthesia Care During Cataract

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Propofol Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

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 ]

Enrollment:	24
Study Start Date:	April 2008
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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

Active Comparator: Propofol

Drug: Propofol

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

Experimental: Dexmedetomidine

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

Locations

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

Sponsors and Collaborators

Cooper University Hospital

Investigators

Principal Investigator:

Jeffrey Littman, MD

The Cooper Health System

More Information

No publications provided

Responsible Party:	Jeffrey Littman, MD, Cooper University Hospital
ClinicalTrials.gov Identifier:	NCT00786370 History of Changes
Other Study ID Numbers:	RP 08-045
Study First Received:	November 5, 2008
Last Updated:	February 9, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Cooper University Hospital:

propofol
dexmedetomidine
cataract

respiratory
blood pressure
Cataract surgery

Additional relevant MeSH terms:

Cataract
Lens Diseases
Eye Diseases
Propofol
Dexmedetomidine
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013