Optimizing Propofol in Obese Patients

Hysterectomy Clinical Trial

Official title:

Optimizing Propofol in Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270335
• Other study ID #: 2005-005400-17
• Secondary ID: GCP-2005-087KF 0
• Status: Completed
• Phase: Phase 4
• First received: December 23, 2005
• Last updated: October 15, 2009
• Start date: January 2006
• Est. completion date: August 2007

Study information

• Verified date: October 2009
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Drug:
• Propofol

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia, Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet	Copenhagen
Denmark	Department of Anaesthesia, Copenhagen University Hospital Herlev	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Meyhoff CS, Henneberg SW, Jørgensen BG, Gätke MR, Rasmussen LS. Depth of anaesthesia monitoring in obese patients: a randomized study of propofol-remifentanil. Acta Anaesthesiol Scand. 2009 Mar;53(3):369-75. doi: 10.1111/j.1399-6576.2008.01872.x. Epub 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia.			No
Secondary	Propofol dose in obese patients undergoing hysterectomy.			No
Secondary	Postoperative consumption of analgesics.		24 h after surgery	No
Secondary	The algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60.			No