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

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National University of Malaysia

Criteria

Inclusion Criteria:

Patients aged 18 years old and above Body mass index of above 25 kg/m2 Patients Undergoing Elective/emergency surgery in UKMMC with an expected duration of 1 hour

Exclusion Criteria:

Patients receiving sedative pre anaesthetic medications from the benzodiazepine group of medications Patients who are in overt sepsis with hemodynamic compromise