Dosage of Propofol Based on Lean Body Weight

Sponsor
Inonu University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06018623
Collaborator
(none)
90
1
4.5
20

Study Details

Study Description

Brief Summary

Patients who will be induction of anesthesia with propofol will have a body analysis with Tanita before the operation. Patients' height, weight, age, gender and other general information will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body weight (LBW) of the patients will be calculated. Patients over the age of 18 who will be operated under general anesthesia for 2-6 hours will be included. Patients with propofol allergy or contraindicated to propofol are included in the study. In order to decide and try the most appropriate weight-based scalar for propofol dosing for anesthesia induction to be evaluated by specifying patients who need additional propofol during intubation in the study, Ingrande et al. 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral index (BIS). ) monitorization, propofol infusion (100 mg/kg/hour) will be started according to total body weight, and the infusion will be stopped with a BIS value between 50 and 40, and the elapsed time will be recorded. Routine anesthesia applications will be performed with neuromuscular blocker applied. The total dose of Propofol given; the dose applied to kilograms will be calculated according to TBW, IBW and LBW. And the relationship between the given doses and the body mass index will be evaluated.

Condition or Disease Intervention/Treatment Phase
  • 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

Detailed Description

Patients who will be induction of anesthesia with propofol will have a body analysis with Tanita before the operation. Patients' height, weight, age, gender and other general information will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body weight (LBW) of the patients will be calculated. Patients over the age of 18 who will be operated under general anesthesia for 2-6 hours will be included. Patients with propofol allergy or contraindicated to propofol are included in the study. In order to decide and try the most appropriate weight-based scalar for propofol dosing for anesthesia induction to be evaluated by specifying patients who need additional propofol during intubation in the study, Ingrande et al. 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral index (BIS). ) monitorization, propofol infusion (100 mg/kg/hour) will be started according to total body weight, and the infusion will be stopped with a BIS value between 50 and 40, and the elapsed time will be recorded. Routine anesthesia applications will be performed with neuromuscular blocker applied. The total dose of Propofol given; the dose applied to kilograms will be calculated according to TBW, IBW and LBW. And the relationship between the doses given and the 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 bodymass index below 35.Patients who will be induction of anesthesia with propofol will have a body analysis with Tanita before the operation. Patients' height, weight, age, gender and other general information will be recorded. Total body weight (TBW), ideal body weight (IBW) and lean body weight (LBW) of the patients will be calculated. Patients over the age of 18 who will be operated under general anesthesia for 2-6 hours will be included. Patients with propofol allergy or contraindicated to propofol are included in the study. In order to decide and try the most appropriate weight-based scalar for propofol dosing for anesthesia induction to be evaluated by specifying patients who need additional propofol during intubation in the study, Ingrande et al. 80 patients with a mean body mass index [BMI] between 18-35 and Bispectoral index (BIS). ) monitorization, propofol infusion (100 mg/kg/hour) will be started according to total body weight, and the infusion will be stopped with a BIS value between 50 and 40, and the elapsed time will be recorded. Routine anesthesia applications will be performed with neuromuscular blocker applied. The total dose of Propofol given; the dose applied to kilograms will be calculated according to TBW, IBW and LBW. And the relationship between the doses given and the 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 bodymass index below 35.

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Lean Body Weight Scalar for the Anesthetic Induction Dose of Propofol
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Jan 30, 2024

Arms and Interventions

Arm Intervention/Treatment
grup1

Group 1 BMI = 18.5-24.9,

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

Group 2 BMI = 25-29.9

BMI = 25-29.9,

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

Group 3

BMI=30-34.9

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

Outcome Measures

Primary Outcome Measures

  1. PROPOFOL DOSE [2]

    THE RATIO OF PROPOFOL DOSE WITH SUFFICIENT DEPTH OF ANESTHESIA ACCORDING TO TOTAL AND LEATHER BODY WEIGHT

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

-

Exclusion Criteria:

PATIENT DOESN'T WANT CONTRAINDICATION OF PROPOFOL Propofol allergy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inonu universitesi Malatya Turkey 44050

Sponsors and Collaborators

  • Inonu University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
DUYGU DEMİROZ, dr, Inonu University
ClinicalTrials.gov Identifier:
NCT06018623
Other Study ID Numbers:
  • TOTM
First Posted:
Aug 30, 2023
Last Update Posted:
Aug 30, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by DUYGU DEMİROZ, dr, Inonu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 30, 2023