NCT06862349: propofol

Propofol Induction Based on Lean Body Weight on the Depth of Anesthesia

Completed Phase 4 Last updated 6 March 2025

What this trial tests

Phase 4 trial testing Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight in Propofol Adverse Reaction in 120 participants. Completed in 27 February 2025.

Timeline

1 January 2025

Primary endpoint
20 February 2025

27 February 2025

Quick facts

Lead sponsor	Ankara City Hospital Bilkent
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	1 January 2025
Primary completion	20 February 2025
Estimated completion	27 February 2025
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight — full drug profile →
• Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist.

Conditions studied

• Propofol Adverse Reaction — all drugs for Propofol Adverse Reaction →

Sponsor

Ankara City Hospital Bilkent

Who can join

Adults 18 to 65, any sex, with Propofol Adverse Reaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Propofol has significant hemodynamic side effects. It is a lipophilic agent and is generally used at a dose of 2-2.5 mg/kg for induction. In patients with a body mass index (BMI) greater than 25, it can lead to serious complications. This patient group often has comorbidities such as hypertension, coronary artery disease, left ventricular hypertrophy, stroke, and obstructive sleep apnea.

Hemodynamic profile changes are influenced by both the rate of propofol administration and the total dose. Therefore, it is necessary to investigate the appropriate dose and infusion rate of propofol during anesthesia induction.

The primary aim of this study is to compare the effects of propofol induction doses, determined based on total body weight and lean body weight (calculated using tomography), on anesthesia depth using BIS and SedLine monitoring in patients with BMI \>25.

The secondary aim of the study is to compare propofol induction doses calculated using two different methods in terms of:

* Mean arterial pressure (MAP),
* Frequency of hypotension (MAP \<65),
* Frequency of Trendelenburg position or vasopressor requirement and their response,
* Tachycardia (heart rate \>100 bpm),
* Frequency of hypertension (SBP \>140).

Additionally, the sensitivity and delay rates of BIS and SedLine monitoring in determining anesthesia depth were compared.

A total of 120 patients undergoing general anesthesia for urological surgeries at our hospital were included in the study. Patients were randomized into two groups (Group T/Group L). All patients were taken to the operating room, and in addition to routine monitoring, BIS and SedLine monitoring were provided. All patients received 1 mcg/kg of fentanyl.

* Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight.
* Group L received propofol at a dose of 2-2.5 mg/kg based on lean body weight, which was calculated from CT imaging by a radiologist.
* Propofol was administered at a rate of 100 mg/min.

The laryngeal mask will be placed once an adequate depth of anesthesia is achieved.

All data were recorded at 2-minute intervals for 6 minutes before and after induction. The collected data were statistically analyzed for comparison.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.