Optimizing Propofol in Obese Patients - Full Text View

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00270335

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 IV

MedlinePlus related topics: Anesthesia Hysterectomy Obesity

Drug Information available for: Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Optimizing Propofol in Obese Patients

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
A: Active Comparator General anesthesia titrated according to a cerebral state monitor	Drug: Propofol
B: Active Comparator 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

Responsible Party:	Department of Anaesthesia, HOC, Copenhagen University Hospital, Rigshospitalet ( Lars S. Rasmussen )
Study ID Numbers:	2005-005400-17, GCP-2005-087, KF 02 284302
Study First Received:	December 23, 2005
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00270335
Health Authority:	Denmark: National Board of Health

Study placed in the following topic categories:

Obesity
Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009