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

Phase 4

Completed

• Conditions: Propofol Adverse Reaction
• Interventions: Drug: Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight; Drug: Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist.

• Registration Number: NCT06862349
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Primary Completion: 2025-02-20
• Study Completion: 2025-02-27
• Status Verified: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• A total of 120 patients of both genders,
• Aged 18-65 years,
• BMI >25
• Scheduled for elective surgery under general anesthesia in the urology operating room

Exclusion Criteria

• Patients under 18 years of age or over 65 years old
• Patients unable to read, understand, or sign the consent form
• Hemodynamically unstable patients
• Patients with contraindications to anesthetic drugs
• Patients who do not wish to participate in the study
• Patients deemed unsuitable by the researcher
• Patients with advanced dementia or behavioral disorders
• Patients using psychiatric medications or abusing drugs
• Patients requiring awake intubation
• Emergency surgical procedures
• Patients with more than a 5% weight change between the time of the CT scan --and the surgery day
• A time gap of more than 2 months between the CT scan and the surgery day

The criteria for discontinuing the study are as follows:

• Patients who develop anaphylaxis
• Airway failure
• Patients who develop unexpected complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T	Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight	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. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved.
Group L	Group L received propofol at 2-2,5mg/kg dose based on lean body weight, which was calculated from CT imaging by a radiologist.	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 lean body weight. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved.

Primary Outcome Measures

Name	Time	Method
anaesthesia debt	30 minute	Anesthesia depth was assessed using BIS and SedLine monitoring before and after induction and recorded every 2 minutes.

Secondary Outcome Measures

Name	Time	Method
mean arterial pressure	30 minute	Mean arterial pressure was measured before and after induction and recorded every 2 minutes.
trendelenburg	30 minute	The need for Trendelenburg position due to hypotension before and after induction was recorded every 2 minutes.
vasopressor	30 minute	The need for vasopressor due to hypotension before and after induction was recorded every 2 minutes.
heart	30 minute	Heart rate was recorded every 2 minutes before and after induction, allowing the rate of tachycardia development to be monitored as a study outcome.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Çankaya, Ankara, Turkey