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Sponsored by: |
Cooper University Hospital |
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Information provided by: | Cooper University Hospital |
ClinicalTrials.gov Identifier: | NCT00848991 |
Primary Hypothesis: The use of a Precedex infusion, in addition to propofol during surgery, will improve patient management through the anesthesia postoperative recovery period determined by improvement in patients? tolerance of the endotracheal tube. Secondary hypothesis: The use of a Precedex infusion, in addition to propofol during surgery will provide improved hemodynamic stability.
Condition | Intervention | Phase |
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Cranitomy Surgery |
Drug: Precedex Drug: Propofol |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Single Group Assignment |
Official Title: | Comparison of Propofol Standard Anesthetic to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery |
Estimated Enrollment: | 15 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Precedex: Active Comparator
In the operating room routine anesthesia monitors will be placed and vital signs will be recorded continuously using data collection software. A routine propofol anesthetic will be administered to subjects randomized to the control group or a Precedex infusion with propofol for subjects randomized to the treatment group. Precedex infusion will be started after induction of general anesthesia. Vital signs (SBP, DBP, MAP) will be recorded continuously throughout the surgery. At the end of the case subjects will be extubated and the blinded observer will assess emergence from anesthesia based on hemodynamic stability and tolerance of the endotracheal tube. Videotaping of emergence will be used to assist in the evaluation of emergence of anesthesia and extubation. |
Drug: Precedex
Subjects randomized to the comparison group will receive a standardized general anesthetic. Anesthesia will be induced with propofol 1.5 ? 2.5 mg/kg, rocuronium 0.6 mg/kg, and sufentanil 0.1 ? 1mcg/kg. Anesthesia will be maintained with an infusion with propofol 25 -200 mcg/kg/min, sufentanil 0.0025 - 0.03 mcg/kg/min, and zemuron as needed. For the Precedex group the drug will be infused at 0.3-0.7 mcg/kg/hr. Blood pressure will be maintained within 10% of baseline prior to opening of the dura, subsequently to be maintained between a systolic of 100 ? 130 mmHg. Hypertension will be managed with standardized amounts of labetalol and nicardipine. Morphine will be titrated as needed to a maximum of 0.05mcg/kg at the conclusion of case. Hemodynamic data and emergence evaluations will be collected in the operating room, pre-induction until the end of anesthesia and discharge from the operating room. There will be no further follow up. |
Propofol: Active Comparator
Propofol for emergence from anesthesia
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Drug: Propofol
evaulation of propofol for emergence from anesthesia
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The purpose of this study is to compare the addition of Precedex to a propofol intravenous anesthetic for emergence from anesthesia in patients having craniotomy surgery for brain tumors.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Misbin, MD | 856-968-8537 | Misbin-Michael@cooperhealth.edu |
Contact: Ashley Shapiro, BA | 856-968-7333 | Shapiro-ashley@cooperhealth.edu |
United States, New Jersey | |
Cooper University Hospital | |
Camden, New Jersey, United States, 08103 |
Principal Investigator: | Michael Misbin, MD | Cooper University Hospital |
Responsible Party: | Cooper University Hospital ( Dr. Michael Misbin ) |
Study ID Numbers: | 01 |
Study First Received: | December 17, 2008 |
Last Updated: | February 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00848991 History of Changes |
Health Authority: | United States: Institutional Review Board |
precedex propofol |
Anesthetics, Intravenous Morphine Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Rocuronium Anesthetics Central Nervous System Depressants Sufentanil Adrenergic Agonists |
Labetalol Analgesics, Non-Narcotic Anesthetics, General Hypnotics and Sedatives Peripheral Nervous System Agents Dexmedetomidine Analgesics Propofol Nicardipine |
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 |
Sensory System Agents Anesthetics, General Analgesics, Non-Narcotic Therapeutic Uses Hypnotics and Sedatives Peripheral Nervous System Agents Dexmedetomidine Analgesics Propofol Central Nervous System Agents |