Dosage of Propofol Based on Lean Body Weight

Anesthesia Clinical Trial

Official title:

Lean Body Weight Scalar for the Anesthetic Induction Dose of Propofol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06018623
• Other study ID #: TOTM
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: Inonu University
• Contact: duygu demiroz, dr
• Phone: 905319504421
• Email: drduygudemiroz[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients who will be anesthesia induced with propofol will be body analyzed with Tanita before the operation. Height, weight, age, gender and other general information of the patients will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body weight (LBW) will be calculated. Patients over 18 years of age who will be operated under general anesthesia for 2-6 hours will be included. Patients allergic to propofol or contraindicated to propofol will be excluded. In the study, in order to decide and test the most appropriate weight-based scale for the evaluation of propofol dosage for induction of anesthesia by identifying patients who need additional propofol during intubation, Ingrande et al. After monitoring, propofol infusion (100 mg/kg/hour) will be started according to total body weight and the infusion will be stopped when the BIS value is between 50 and 40 and the elapsed time will be recorded. Routine anesthesia applications will be performed by applying neuromuscular blocker. Total Propofol dose administered will be calculated according to the dose TBW, IBW and LBW in kilograms. The relationship between the doses administered and body mass index will be evaluated.

Description:

Patients who will be anesthesia induced with propofol will be body analyzed with Tanita before the operation. Height, weight, age, gender and other general information of the patients will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body weight (LBW) will be calculated. Patients over 18 years of age who will be operated under general anesthesia for 2-6 hours will be included. Patients who are allergic to propofol or for whom propofol is contraindicated will not be included in the study. In the study, 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral index (BIS) (Ingrande et al. ) monitoring, propofol infusion (100 mg/kg/hour) will be started according to total body weight, and when the BIS value is between 50 and 40, the infusion will be stopped and the elapsed time will be recorded in order to decide and test the most appropriate weight-based scale for propofol dosing for anesthesia induction to identify and evaluate patients who need additional propofol during intubation. Routine anesthesia will be performed by applying neuromuscular blocker. Total Propofol dose administered will be calculated according to TBW, IBW and LBW per kilogram. And the relationship between the doses given and body mass index will be evaluated. In our study, we aimed to evaluate the effects of Propofol dose according to lean body weight by evaluating patients with a body mass index below 35.Patients who will undergo anesthesia induction with Propofol will undergo preoperative body analysis with Tanita. Height, weight, age, gender and other general information of the patients will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body weight (LBW) will be calculated. Patients over 18 years of age who will be operated under general anesthesia for 2-6 hours will be included. Patients who are allergic to propofol or for whom propofol is contraindicated will not be included in the study. In the study, 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral index (BIS) (Ingrande et al. ) monitoring, propofol infusion (100 mg/kg/hour) will be started according to total body weight, and when the BIS value is between 50 and 40, the infusion will be stopped and the elapsed time will be recorded in order to decide and test the most appropriate weight-based scale for propofol dosing for anesthesia induction to identify and evaluate patients who need additional propofol during intubation. Routine anesthesia will be performed by applying neuromuscular blocker. Total Propofol dose administered will be calculated according to TBW, IBW and LBW per kilogram. And the relationship between the doses given and body mass index will be evaluated. In our study, we aimed to evaluate the effects of Propofol dose according to lean body weight by evaluating patients with a body mass index below 35.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: November 30, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria: BMI 18-35 will be included. over 18 years old It will take 2-6 hours Patients who will be operated under general anesthesia will be included.

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Exclusion Criteria:

PATIENT DOESN'T WANT CONTRAINDICATION OF PROPOFOL Propofol allergy

Related Conditions & MeSH terms

• Anesthesia
• Body Weight
• Gender

Intervention

Other:
• It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patients
It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patients

Locations

Country	Name	City	State
Turkey	Inonu universitesi	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Barras M, Legg A. Drug dosing in obese adults. Aust Prescr. 2017 Oct;40(5):189-193. doi: 10.18773/austprescr.2017.053. Epub 2017 Oct 3. No abstract available. — View Citation

Fujimoto M, Tanahira C, Nishi M, Yamamoto T. In non-obese patients, duration of action of rocuronium is directly correlated with body mass index. Can J Anaesth. 2013 Jun;60(6):552-6. doi: 10.1007/s12630-013-9914-x. Epub 2013 Mar 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROPOFOL DOSE	THE RATIO OF PROPOFOL DOSE WITH SUFFICIENT DEPTH OF ANESTHESIA ACCORDING TO TOTAL AND LEATHER BODY WEIGHT	2

External Links

•   Drug dosing in obese adults
•   In non-obese patients, duration of action of rocuronium is directly correlated with body mass index.