Optimizing propofol in obese patients

Phase 1

• Conditions: Depth of anesthesia during hysterescomia in propofol/remifentanil anaesthesia

• Registration Number: EUCTR2005-005400-17-DK
• Lead Sponsor: Dept. of Anaesthesia, Center of Head and Orthopaedics, Copenhagen University Hospital Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-06
• Last Update Posted: 3 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

Elective abdominal non-laparoscopic hysterectomia
Age>18 years
ASA physical status I-III
Body Mass Index =30
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Allergic towards propofol
Daily consumption of benzodiazepine (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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To optimize propofol dosing in obese patients undergoing hysterectomia.<br><br>Main hypothesis: Monitoring the depth of anaesthesia using the Cerebral State MonitorTM (CSM) reduce time to opening eyes in obese patients after hysterectomia in propofol/remifentanil anaethesia.<br>;Secondary Objective: Secondary hypotheses: CSM-monitoring reduce propofol dose in obese patients undergoing hysterectomia. Patients with a high CSM-level CSM-niveau during hysterectomia have higher postoperative consumption of analgesics. Supplementary, an algoritm for the dose of propofol that most frequently results in a CSM-level between 40 og 60 is calculated.<br>;Primary end point(s): Time to opening eyes in obese patients after hysterectomia in propofol/remifentanil anaethesia with or without CSM-guidance.