drugset / Trial / NCT00270335

Optimizing Propofol in Obese Patients

NCT00270335 ↗

Phase 4 Completed 38 enrolled Rigshospitalet, Denmark
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2006-01
Primary completion
2007-08
Completion
2007-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule 10 mg/kg Intravenous

Indications

No indication recorded.