Optimizing Propofol in Obese Patients

October 15, 2009 updated by: Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100
        • Department of Anaesthesia, Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet
      • Herlev, Denmark, DK-2730
        • Department of Anaesthesia, Copenhagen University Hospital Herlev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
General anesthesia titrated according to a cerebral state monitor
Drug: Propofol
Active Comparator: B
General anesthesia titrated according to usual clinical criteria
Drug: Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Lars S. Rasmussen, MD, PhD, Department of anesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

December 23, 2005

First Submitted That Met QC Criteria

December 23, 2005

First Posted (Estimate)

December 26, 2005

Study Record Updates

Last Update Posted (Estimate)

October 16, 2009

Last Update Submitted That Met QC Criteria

October 15, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-005400-17
  • GCP-2005-087
  • KF 02 284302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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