The Effect of Propofol Induction Based on Lean Body Weigh... | NCT06862245

Status Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group T	Active Comparator	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.	Drug: T received propofol at a dose of 2-2.5 mg/kg based on total body weight
Group L	Active Comparator	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.	Drug: Group L received propofol at 2-2,5mg/kg dose based on le

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
anaesthesia debt based on BIS (bispectral index)	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.	30 minute
anaesthesia debt based on the SedLine value	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.	30 minute

Secondary Outcomes

Measure	Description	Time Frame
mean arterial pressure	Mean arterial pressure was measured before and after induction and recorded every 2 minutes.	30 minute
trendelenburg	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

Eligibility Module

Name	Affiliation	Role
Seda Kurtbeyoğlu, doctor	Ankara City Hospital Bilkent	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Ankara Bilkent City Hospital		Çankaya	Ankara	06800	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29902969	Result	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.
16508396	Result	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.