NCT00270335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 26, 2005

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

1.6 years

First QC Date

December 23, 2005

Last Update Submit

October 15, 2009

Conditions

Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia.

Secondary Outcomes (3)

  • Propofol dose in obese patients undergoing hysterectomy.

  • Postoperative consumption of analgesics.

    24 h after surgery

  • The algorithm for the dose of propofol that most frequently results in a CSM-level between 40 and 60.

Study Arms (2)

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

Interventions

PropofolDRUG
AB

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective abdominal non-laparoscopic hysterectomy
  • Age \> 18 years
  • ASA physical status I-III
  • Body Mass Index 30 or above

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Anaesthesia, Juliane Marie Centre, Copenhagen University Hospital Rigshospitalet

Copenhagen, DK-2100, Denmark

Location

Department of Anaesthesia, Copenhagen University Hospital Herlev

Herlev, DK-2730, Denmark

Location

Related Publications (1)

  • Meyhoff CS, Henneberg SW, Jorgensen BG, Gatke 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 2009 Jan 23.

    PMID: 19173688RESULT

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Lars S. Rasmussen, MD, PhD

    Department of anesthesia, 4231, Center of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 23, 2005

First Posted

December 26, 2005

Study Start

January 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

DK(2)