Optimizing Propofol in Obese Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00270335

Enrollment

Registered

2005-12-26

Start date

2006-01-31

Completion date

2007-08-31

Last updated

2009-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy

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.

Interventions

DRUGPropofol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Time to opening eyes in obese patients after hysterectomy in propofol anaesthesia.	—

Secondary

Measure	Time frame
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.	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026