Comparison of Propofol to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery

This study has been completed.
Sponsor:
Information provided by:
The Cooper Health System
ClinicalTrials.gov Identifier:
NCT00848991
First received: December 17, 2008
Last updated: February 9, 2012
Last verified: February 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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 The Cooper Health System:

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 ]

Enrollment: 15
Study Start Date: February 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Precedex
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.
Active Comparator: Propofol
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848991

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

No publications provided

Responsible Party: Dr. Michael Misbin, Cooper University Hospital
ClinicalTrials.gov Identifier: NCT00848991     History of Changes
Other Study ID Numbers: 01
Study First Received: December 17, 2008
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cooper Health System:
precedex
propofol

Additional relevant MeSH terms:
Anesthetics
Propofol
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
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 July 29, 2014