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Comparison of Propofol to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery
This study is not yet open for participant recruitment.
Verified by Cooper University Hospital, February 2009
First Received: December 17, 2008   Last Updated: February 20, 2009   History of Changes
Sponsored by: Cooper University Hospital
Information provided by: Cooper University Hospital
ClinicalTrials.gov Identifier: NCT00848991
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Cooper University Hospital:

Primary Outcome Measures:
  • The use of Precedex for craniotomy surgery offers the potential for improved hemodynamic control and improved tolerance of the endotracheal tube, therefore potentially benefiting these patients. [ Time Frame: 4 hours after awaking from surgery ] [ Designated as safety issue: Yes ]

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
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
Drug: Propofol
evaulation of propofol for emergence from anesthesia

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA status 1, 2, and 3

Exclusion Criteria:

  • ASA status 4 and 5 patients
  • Patients with positive pregnancy tests
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848991

Contacts
Contact: Michael Misbin, MD 856-968-8537 Misbin-Michael@cooperhealth.edu
Contact: Ashley Shapiro, BA 856-968-7333 Shapiro-ashley@cooperhealth.edu

Locations
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
Cooper University Hospital
Investigators
Principal Investigator: Michael Misbin, MD Cooper University Hospital
  More Information

No publications provided

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

Keywords provided by Cooper University Hospital:
precedex
propofol

Study placed in the following topic categories:
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

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

ClinicalTrials.gov processed this record on August 30, 2009