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Validation of the predictability of the pharmacokinetic model for propofol in underweight patients under general anesthesia

External validation of the pharmacokinetic model for propofol in underweight patients under general anesthesia

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0002171
Enrollment
20
Registered
2016-12-16
Start date
2016-11-10
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Procedure/Surgery : Patients will receive general anesthesia by effect-site target-controlled infusion of propofol using the underweight pharmacokinetic model, to maintain bispectral index below 60. R

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 20 to 65 years of age 2. BMI (body mass index) < 18.5 (kg/m2) 3. Hemoglobin > 9 g/dl 4. Patients who signed a written informed consent form

Exclusion criteria

Exclusion criteria: 1-1. Patients with severely impaired respiratory function or respiratory depression status 1-2. Patients with convulsive disorders, head injury, shock, a reduced level of consciousness of uncertain origin, intracranial lesions or increased intracranial pressure, or in patients with severe hepatic impairment 1-3. Patients who are concurrently taking other central nervous system (CNS) depressants that may cause respiratory depression, hypotension, profound sedation or potentially result in coma 1-4. Clinically significant impairment of cardiovascular, respiratory and renal function 2. Patients with known hypersensitivity to intervention treatments (propofol) or to any of the excipients 3. Patients who recieved other investigational drugs within 7 days before participation. 4. Patients who are considered by the investigator to be unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria.

Design outcomes

Primary

MeasureTime frame
Plasma concentration of propofol

Secondary

MeasureTime frame
Bispectral index

Countries

Korea, Republic of

Contacts

Public ContactByungmoon Choi

Asan Medical Center

rios76@hanmail.net+82-2-3010-1704

Outcome results

None listed

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