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NCT Number: NCT06862245

The Effect of Propofol Induction Based on Lean Body Weight on the Depth of 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.

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Key information

Conditions

Propofol Adverse Reaction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Çankaya, Ankara, 06800, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T received propofol at a dose of 2-2.5 mg/kg based on total body weight

Drug

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.

Group L received propofol at 2-2,5mg/kg dose based on le

Drug

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

Primary outcomes

  1. anaesthesia debt based on BIS (bispectral index)

    Time frame: 30 minute

    Anesthesia depth was assessed using BIS (bispectral index) monitoring before and after induction and recorded every 2 minutes. A numeric value is recorded in the range of 0-100.

  2. anaesthesia debt based on the SedLine value

    Time frame: 30 minute

    Anesthesia depth was assessed using SedLine monitoring before and after induction and recorded every 2 minutes. A numeric value is recorded in the range of 0-100.

Secondary outcomes

  1. mean arterial pressure

    Time frame: 30 minute

    Mean arterial pressure was measured before and after induction and recorded every 2 minutes.

  2. trendelenburg

    Time frame: 30 minute

    Patients with a mean arterial pressure of <65 were placed in the Trendelenburg position, and the presence of a hemodynamic response was recorded. The need for Trendelenburg position due to hypotension before and after induction was recorded every 2 minutes

  3. vasopressor

    Time frame: 30 minute

    Patients with a mean arterial pressure of <65 were placed in the Trendelenburg position. Vasopressors were administered to patients with a mean arterial pressure below 65 mmHg who did not exhibit a hemodynamic response to trendelenburg position. The need for vasopressor due to hypotension before and after induction was recorded every 2 minutes.

  4. heart

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Acronym: Propofol

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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