Optimizing Propofol in Obese Patients

This study has been completed.
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
First received: December 23, 2005
Last updated: October 15, 2009
Last verified: October 2009

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.

Condition Intervention Phase
Drug: Propofol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Propofol in Obese Patients

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Propofol dose in obese patients undergoing hysterectomy. [ Designated as safety issue: No ]
  • Postoperative consumption of analgesics. [ Time Frame: 24 h after surgery ] [ Designated as safety issue: No ]
  • The algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60. [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: January 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270335

Department of Anaesthesia, Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, DK-2100
Department of Anaesthesia, Copenhagen University Hospital Herlev
Herlev, Denmark, DK-2730
Sponsors and Collaborators
Rigshospitalet, Denmark
Study Chair: Lars S. Rasmussen, MD, PhD Department of anesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
  More Information

Responsible Party: Lars S. Rasmussen, Department of Anaesthesia, HOC, Copenhagen University Hospital, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00270335     History of Changes
Other Study ID Numbers: 2005-005400-17, GCP-2005-087, KF 02 284302
Study First Received: December 23, 2005
Last Updated: October 15, 2009
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on April 17, 2014