Propofol Induction Based on Lean Body Weight on the Depth of Anesthesia (propofol)

The Effect of Propofol Induction Using Total Body Weight and Lean Body Weight Obtained by Tomographic Measurements; on the Depth of Anesthesia in Patients Receiving General Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Propofol Adverse Reaction
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Çankaya, Ankara, Turkey, 06800
      • Ankara Bilkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group T; 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.	Drug: Group T received propofol at a dose of 2-2.5 mg/kg based on total body weight; 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. 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.
Active Comparator: 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 lean body weight. The laryngeal mask will be placed once an adequate depth of anesthesia is achieved.	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.; 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 L received propofol at 2-2,5mg/kg dose 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anaesthesia debt	Anesthesia depth was assessed using BIS and SedLine monitoring before and after induction and recorded every 2 minutes.	30 minute

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Rusch D, Arndt C, Eberhart L, Tappert S, Nageldick D, Wulf H. Bispectral index to guide induction of anesthesia: a randomized controlled study. BMC Anesthesiol. 2018 Jun 15;18(1):66. doi: 10.1186/s12871-018-0522-8.
• Pilge S, Zanner R, Schneider G, Blum J, Kreuzer M, Kochs EF. Time delay of index calculation: analysis of cerebral state, bispectral, and narcotrend indices. Anesthesiology. 2006 Mar;104(3):488-94. doi: 10.1097/00000542-200603000-00016.
• Gurses E, Sungurtekin H, Tomatir E, Dogan H. Assessing propofol induction of anesthesia dose using bispectral index analysis. Anesth Analg. 2004 Jan;98(1):128-131. doi: 10.1213/01.ANE.0000090314.43496.1D.
• Schmidt GN, Bischoff P, Standl T, Lankenau G, Hilbert M, Schulte Am Esch J. Comparative evaluation of Narcotrend, Bispectral Index, and classical electroencephalographic variables during induction, maintenance, and emergence of a propofol/remifentanil anesthesia. Anesth Analg. 2004 May;98(5):1346-53, table of contents. doi: 10.1213/01.ane.0000111209.44119.30.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: general anaesthesia; lean body mass; propofol adverse reaction
• Additional Relevant MeSH Terms: Body Weight; Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Propofol
• Other Study ID Numbers: propofol induction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No