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Optimizing Propofol in Obese Patients

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00270335
First received: December 23, 2005
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  Purpose

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
Hysterectomy
 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:

MedlinePlus related topics: Hysterectomy Obesity
Drug Information available for: Propofol
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

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:
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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 June 18, 2013