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Prospective Validation Of The Eleveld TCI Model For Propofol In The Malaysian Obese Population

NCT05885100 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-06-01

No results posted yet for this study

Summary

This is a prospective single blinded randomized trial to validate the 2014 published and widely used Eleveld TCI model which is a universal model suitable for use in all age groups and is suitable for all patients even in the extremes of weight.

This study involves 36 patients who meet the inclusion and exclusion criteria that have been set. Once consent obtained patients will undergo surgery utilizing total intravenous anaesthesia via the target control infusion method and plasma levels of propofol will be sampled sequentially for 1 hour during surgery and analysed to compare the difference between the set and measured level of propofol in plasma. From this data obtained the median absolute prediction error calculated. The secondary goal of this study is to assess the BIS-Propofol correlation in the obese population as well as the hemodynamic stability of this particular model in the obese population.

The data from this study will allow a more targeted anaesthetic approach in the obese population and prevent morbidities in our future practice.

Conditions

  • Total Intravenous Anaesthesia, Eleveld Model, Obes

Interventions

DRUG

Eleveld Model

Target plasma propofol

Sponsors & Collaborators

  • National University of Malaysia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-11-30
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05885100 on ClinicalTrials.gov