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OpenTrials
Completed

NCT Number: NCT00270335

Optimizing Propofol in Obese Patients

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.

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Key information

Conditions

Hysterectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

Primary outcomes

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 26, 2005
Registry last updated
Oct 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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