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Optimizing Propofol in Obese Patients

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ClinicalTrials.gov Identifier: NCT00270335
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : October 16, 2009
Sponsor:
Information provided by:
Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Hysterectomy Drug: Propofol Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Propofol in Obese Patients
Study Start Date : January 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia.

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270335


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

Publications of Results:
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
First Posted: December 26, 2005    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics