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

Phase 3

Completed

• Conditions: Cranitomy Surgery
• Interventions: Drug: Propofol; Drug: Precedex

• Registration Number: NCT00848991
• Lead Sponsor: The Cooper Health System

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.

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.

Study Timeline

• Study First Submitted: 2008-12-17
• Status Verified: 2009-02
• Study Start: 2009-02
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2012-02-09
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• ASA status 1, 2, and 3

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Propofol for emergence from anesthesia
Precedex	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States