Comparison of Propofol Standard Anesthetic to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- The Cooper Health System
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •ASA status 1, 2, and 3
Exclusion Criteria
- •ASA status 4 and 5 patients
- •Patients with positive pregnancy tests
Arms & Interventions
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.
Intervention: Precedex (Drug)
Propofol
Propofol for emergence from anesthesia
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported