Optimizing Propofol in Obese Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A

General anesthesia titrated according to a cerebral state monitor

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

B

General anesthesia titrated according to usual clinical criteria

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Interventions

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Propofol

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No