Optimizing Propofol in Obese Patients
An accurate dosage of anesthetics during surgery is important. Usually this is achieved through close observation of the patient, but a new monitor (CSM-monitor) can measure the level of anesthesia more closely.
In obese patients dosage of drugs is difficult due to the change in body composition. The CSM-monitor may provide a more accurate dosage of propofol (an anesthetic agent) during surgery, and as a consequence of that, also reduce the postoperative need for analgesics.
Main objective: To optimise propofol dosing in obese patients undergoing hysterectomy.
Main hypothesis: Monitoring the depth of anesthesia using the CSM-monitor reduces time to opening eyes in obese patients after hysterectomy in propofol anesthesia.
Secondary hypotheses: CSM-monitoring reduce propofol dose in obese patients undergoing hysterectomy. Patients with a high CSM-level during hysterectomy have higher postoperative consumption of analgesics. Supplementary, an algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60 is calculated.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Optimizing Propofol in Obese Patients|
- Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia. [ Designated as safety issue: No ]
- Propofol dose in obese patients undergoing hysterectomy. [ Designated as safety issue: No ]
- Postoperative consumption of analgesics. [ Time Frame: 24 h after surgery ] [ Designated as safety issue: No ]
- The algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60. [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Active Comparator: A
General anesthesia titrated according to a cerebral state monitor
Active Comparator: B
General anesthesia titrated according to usual clinical criteria
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270335
|Department of Anaesthesia, Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet|
|Copenhagen, Denmark, DK-2100|
|Department of Anaesthesia, Copenhagen University Hospital Herlev|
|Herlev, Denmark, DK-2730|
|Study Chair:||Lars S. Rasmussen, MD, PhD||Department of anesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet|