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Sponsored by: |
Cooper University Hospital |
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Information provided by: | Cooper University Hospital |
ClinicalTrials.gov Identifier: | NCT00786370 |
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 |
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Cataract |
Drug: dexmedetomidine Drug: Propofol Drug: Dexemedetomidine |
Phase IV |
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 |
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 |
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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
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey Littman, MD | 856-968-7333 | Littman-Jeffrey@cooperhealth.edu |
Contact: Marc Torjman, PhD | 856-757-7814 | Torjmamc@umdnj.edu |
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 |
Principal Investigator: | Jeffrey Littman, MD | The Cooper Health System |
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 |
propofol dexmedetomidine cataract |
respiratory blood pressure Cataract surgery |
Fentanyl Eye Diseases Cataract Lens Diseases |
Dexmedetomidine Propofol Midazolam |
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 |