GenderNCT06018623
Dosage of Propofol Based on Lean Body Weight
An observational study of Gender and Anesthesia, run by Inonu University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender, Anesthesia
- What is being tested?
- It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patients
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: VOLUNTARY PATIENTS BETWEEN 18-65 YEARS WITH NO ADDITIONAL DISEASES
Who may be able to join
None listed.
Who cannot join
- PATIENT DOESN'T WANT CONTRAINDICATION OF PROPOFOL Propofol allergy
Trial locations and contacts
1 site in 1 country.
yusuf ziya colak, dr contact
About this study
Official title: Lean Body Weight Scalar for the Anesthetic Induction Dose of Propofol
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.
Read the detailed 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.
- Conditions
- Gender, Anesthesia
- Being tested
- It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patients
- Keywords
- the lean body weight, propofol intubation conditions
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patientsOther
It is an observational study and no non-routine procedures will be performed on patients.
Routine anesthesia procedure will be applied to the patients
| Study group | Role | What they receive |
|---|---|---|
| grup 1.Optimum range | Group 1 BMI = 18.5-24.9, Receives: 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, Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROPOFOL DOSE
THE RATIO OF PROPOFOL DOSE WITH SUFFICIENT DEPTH OF ANESTHESIA ACCORDING TO TOTAL AND LEATHER BODY WEIGHT
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start15 May 2024 (estimated)
- Primary completion15 Oct 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GenderStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DUYGU DEMİROZ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018623
- Sponsor's protocol ID
- TOTM
- Status last verified
- Mar 2024
- First submitted
- 9 Aug 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29109603Fujimoto 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.
PubMed 23463483
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lean Body Weight Scalar for the Anesthetic Induction Dose of Propofol
- ClinicalTrials.gov ID
- NCT06018623
- Acronym / sponsor ID
- TOTM
- Conditions
- Gender, Anesthesia
- Keywords
- the lean body weight, propofol intubation conditions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| grup 1.Optimum range | – | Other: It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patientsGroup 1 BMI = 18.5-24.9, |
| Group 2.Overweight | – | Other: It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patientsBMI = 25-29.9, |
| Group 3.Class I obesity | – | Other: It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patientsBMI=30-34.9 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- VOLUNTARY PATIENTS BETWEEN 18-65 YEARS WITH NO ADDITIONAL DISEASES
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- PATIENT DOESN'T WANT CONTRAINDICATION OF PROPOFOL Propofol allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| It is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patientsIt is an observational study and no non-routine procedures will be performed on patients. Routine anesthesia procedure will be applied to the patients | Other | Group 2.Overweight, Group 3.Class I obesity, grup 1.Optimum range |
Primary outcome
PROPOFOL DOSE
Time frame: 2
THE RATIO OF PROPOFOL DOSE WITH SUFFICIENT DEPTH OF ANESTHESIA ACCORDING TO TOTAL AND LEATHER BODY WEIGHT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 29109603Barras 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.
- Background: PubMed 23463483Fujimoto 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.
- Drug dosing in obese adultsLink provided by the sponsor.
- In non-obese patients, duration of action of rocuronium is directly correlated with body mass index.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yusuf ziya colak, dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender and Anesthesia, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact duygu demiroz, dr (905319504421, drduygudemiroz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROPOFOL DOSE (time frame: 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018623, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.