Optimizing propofol in obese patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005400-17-DK

Enrollment

Registered

2005-12-06

Start date

2005-12-15

Completion date

Unknown

Last updated

2021-05-03

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

Conditions

Depth of anesthesia during hysterescomia in propofol/remifentanil anaesthesia

Interventions

Trade Name: Propofol Product Name: Propofol Pharmaceutical Form: Emulsion for infusion INN or Proposed INN: propofol Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Elective abdominal non-laparoscopic hysterectomia Age>18 years ASA physical status I-III Body Mass Index =30 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergic towards propofol Daily consumption of benzodiazepine (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
Main Objective: To optimize propofol dosing in obese patients undergoing hysterectomia. Main hypothesis: Monitoring the depth of anaesthesia using the Cerebral State MonitorTM (CSM) reduce time to opening eyes in obese patients after hysterectomia in propofol/remifentanil anaethesia. ;Secondary Objective: Secondary hypotheses: CSM-monitoring reduce propofol dose in obese patients undergoing hysterectomia. Patients with a high CSM-level CSM-niveau during hysterectomia have higher postoperative consumption of analgesics. Supplementary, an algoritm for the dose of propofol that most frequently results in a CSM-level between 40 og 60 is calculated. ;Primary end point(s): Time to opening eyes in obese patients after hysterectomia in propofol/remifentanil anaethesia with or without CSM-guidance.	—

Measure

Time frame

Main Objective: To optimize propofol dosing in obese patients undergoing hysterectomia. Main hypothesis: Monitoring the depth of anaesthesia using the Cerebral State MonitorTM (CSM) reduce time to opening eyes in obese patients after hysterectomia in propofol/remifentanil anaethesia. ;Secondary Objective: Secondary hypotheses: CSM-monitoring reduce propofol dose in obese patients undergoing hysterectomia. Patients with a high CSM-level CSM-niveau during hysterectomia have higher postoperative consumption of analgesics. Supplementary, an algoritm for the dose of propofol that most frequently results in a CSM-level between 40 og 60 is calculated. ;Primary end point(s): Time to opening eyes in obese patients after hysterectomia in propofol/remifentanil anaethesia with or without CSM-guidance.

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Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026