Optimizing Propofol in Obese Patients
|ClinicalTrials.gov Identifier: NCT00270335|
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : October 16, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Hysterectomy||Drug: Propofol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Optimizing Propofol in Obese Patients|
|Study Start Date :||January 2006|
|Primary Completion Date :||August 2007|
|Study Completion Date :||August 2007|
Active Comparator: A
General anesthesia titrated according to a cerebral state monitor
Active Comparator: B
General anesthesia titrated according to usual clinical criteria
- Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia.
- Propofol dose in obese patients undergoing hysterectomy.
- Postoperative consumption of analgesics. [ Time Frame: 24 h after surgery ]
- The algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|