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

Cooper University Health Care

Status and phase: Completed; Phase 3

Conditions: Cranitomy Surgery

Treatments: Drug: Precedex; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT00848991

01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA status 1, 2, and 3

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Precedex

Active Comparator group

Description:

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.

Treatment:

Drug: Precedex

Propofol

Active Comparator group

Description:

Propofol for emergence from anesthesia

Treatment:

Drug: Propofol