CompletedPhase 4

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

Turkey (Türkiye)120 participantsStarted 2025-01-01

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

anaesthesia debt

Timeframe: 30 minute

Trial details

NCT IDNCT06862349

SponsorAnkara City Hospital Bilkent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-20

View on ClinicalTrials.gov More Propofol Adverse Reaction trials