Clinical trial NCT00270335: Optimizing Propofol in Obese Patients
Official title: Optimizing Propofol in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hysterectomy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-12-26
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia.
Secondary outcomes:
measure: Propofol dose in obese patients undergoing hysterectomy.
measure: Postoperative consumption of analgesics.
timeFrame: 24 h after surgery
measure: The algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anaesthesia, Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet
city: Herlev
country: Denmark
facility: Department of Anaesthesia, Copenhagen University Hospital Herlev
Study officials:
affiliation: Department of anesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
name: Lars S. Rasmussen, MD, PhD
role: STUDY_CHAIR
References:
citation: Meyhoff CS, Henneberg SW, Jorgensen BG, Gatke MR, Rasmussen LS. Depth of anaesthesia monitoring in obese patients: a randomized study of propofol-remifentanil. Acta Anaesthesiol Scand. 2009 Mar;53(3):369-75. doi: 10.1111/j.1399-6576.2008.01872.x. Epub 2009 Jan 23.