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

NCT00848991 | Completed Phase 3

• 1 other identifier: 01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cranitomy Surgery

Keywords

precedex; propofol

Outcome Measures

Primary Outcomes (1)

• 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.

  4 hours after awaking from surgery

Study Arms (2)

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

Propofol

ACTIVE COMPARATOR

Propofol for emergence from anesthesia

Drug: Propofol

Interventions

Precedex DRUG

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.

Precedex

Propofol DRUG

evaulation of propofol for emergence from anesthesia

Propofol

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA status 1, 2, and 3

You may not qualify if:

• ASA status 4 and 5 patients
• Patients with positive pregnancy tests

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Michael Misbin, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: February 23, 2009
• Study Start: February 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 10, 2012

Record last verified: 2009-02

Locations

US (1)