Dosage of Propofol Based on Lean Body Weight

NCT ID: NCT06018623

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-15

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gender Anesthesia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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grup 1.Optimum range

Group 1 BMI = 18.5-24.9,

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

Intervention Type 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

Group 2.Overweight

BMI = 25-29.9,

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

Intervention Type 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

Group 3.Class I obesity

BMI=30-34.9

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

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

PATIENT DOESN'T WANT CONTRAINDICATION OF PROPOFOL Propofol allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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DUYGU DEMİROZ

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Inonu universitesi

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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duygu demiroz, dr

Role: CONTACT

905319504421

yusuf ziya colak, dr

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 29109603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23463483 (View on PubMed)

Related Links

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https://doi.org/10.1093/bja/aes368

In non-obese patients, duration of action of rocuronium is directly correlated with body mass index.

Other Identifiers

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TOTM

Identifier Type: -

Identifier Source: org_study_id

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