Optimizing Propofol in Obese Patients

Phase 4

Completed

• Conditions: Hysterectomy
• Interventions: Drug: Propofol

• Registration Number: NCT00270335
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-12-23
• Study First Submitted QC: 2005-12-23
• Study First Posted: 2005-12-26
• Study Start: 2006-01
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-15
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• Elective abdominal non-laparoscopic hysterectomy
• Age > 18 years
• ASA physical status I-III
• Body Mass Index 30 or above

Exclusion Criteria

• Allergic towards propofol
• Daily consumption of benzodiazepines (more than at nighttime), opioids or amphetamine preoperatively.
• Disease with expected EEG-abnormality or impaired auditory function: Epilepsy, deafness, previous neurosurgery, previous or actual neurologic disease with neurologic deficit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Propofol	General anesthesia titrated according to a cerebral state monitor
B	Propofol	General anesthesia titrated according to usual clinical criteria

Primary Outcome Measures

Name	Time	Method
Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia.

Secondary Outcome Measures

Name	Time	Method
Propofol dose in obese patients undergoing hysterectomy.
Postoperative consumption of analgesics.	24 h after surgery
The algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60.

Trial Locations

Locations (2)

Department of Anaesthesia, Copenhagen University Hospital Herlev; 🇩🇰 Herlev, Denmark

Department of Anaesthesia, Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet; 🇩🇰 Copenhagen, Denmark