SevofluraneNCT06018597
The Relationship of Sevoflurane Consumption With Metabolic Age
An observational study of Sevoflurane, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to determine the consumption of sevoflurane, which is one of the inhalation anesthetics, with metabolic age and basal metabolic rate. The basal metabolic rates and metabolic ages of the patients who will be given sevoflurane- maintained general anesthesia were measured preoperatively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sevoflurane
- What is being tested?
- Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mL
- How many people
- 79 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2022to 3 Mar 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: 18-65 AGE
Who may be able to join
- Between the ages of 18-65 who are scheduled for rhinoplasty or septoplasty with ASA I-II Cases lasting 1 to 3 hours
- Exclude Criteria:
- Patients at high risk of malignant hyperthermia, with a history of allergy to general anesthesia or any of the drugs to be used in the study, accepted as ASA III- ASA IV
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this clinical study is to determine the consumption of sevoflurane, which is one of the inhalation anesthetics, with metabolic age and basal metabolic rate. The basal metabolic rates and metabolic ages of the patients who will be given sevoflurane- maintained general anesthesia were measured preoperatively. The relationship between the amount of sevoflurane consumption and the measured data of the patients in the postoperative period was examined.
Read the detailed description
Standard monitoring, BIS, TOF (train of four) were performed from the premedication application. Aspect A 2000 (Aspect Medical Systems, Newton) monitor and single-chip BIS electrodes will be used for BIS. The total amount of sevoflurane consumed and MAK values of these components will be recorded. Chronological age, metabolic age, BMR, height, weight, ideal body weight, BMI, body adiposity, body fluid ratio, body fluid care, fat mass, lean body weight, muscle registered, visceral adiposity, obesity degree in the preoperative period of the patients. Values, ASA scores and demographic data will be recorded for the operation process, cutting time, anesthesia time, extubation time, total sevoflurane consumption throughout the case, and the relationship with basal metabolism and metabolic age will be evaluated.
- Conditions
- Sevoflurane
- Being tested
- Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mL
- Keywords
- Sevoflurane Consumption, Metabolic Age, Tanita
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mLDrug
Also called No procedure was performed on the patient other than routine anesthesia management.
No procedure was performed on the patient other than routine anesthesia management.We compared sevoflurane consumption amount in the patient undergoing general anesthesia with sevoflurane according to their metabolic age.
| Study group | Role | What they receive |
|---|---|---|
| percent age difference < -6.6% | The percentage age difference in the negative direction represents patients whose metabolic age is greater than their chronological age.
When we analyze the ROC analysis in the negative direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percentage age difference is -6,6%.
This group refers to those whose percentage age difference is less than -6.6% Receives: Drug: Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mL | |
| percent age difference -6.6% to 11.7% those between | When we analyze the ROC analysis in the negative direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percentage age difference is -6,6%. When we analyze the ROC analysis in the positive direction, the cut-off value of the percent age difference is 11.7%.
This group refers to those whose percentage age difference between -6.6% and 11.7% Receives: Drug: Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mL | |
| percent age difference > 11.7% | the percent age difference in the positive direction represents patients whose metabolic age is less than their chronological age.
When we analyze the ROC analysis in the positive direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percent age difference is 11.7%.
This group refers to those whose percentage age difference is more than 11.7% Receives: Drug: Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
consumption of sevoflurane
Reducing patients' consumption of sevoflurane according to metabolic law
Measured: patients during surgery
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 start9 Sep 2022
- Primary completion1 Mar 2023
- Study completion3 Mar 2023
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 SevofluraneStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
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
- NCT06018597
- Sponsor's protocol ID
- Inonu 2022/92
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
St-Onge MP, Gallagher D. Body composition changes with aging: the cause or the result of alterations in metabolic rate and macronutrient oxidation? Nutrition. 2010 Feb;26(2):152-5. doi: 10.1016/j.nut.2009.07.004. Epub 2009 Dec 8.
PubMed 20004080Ng JCM, Schooling CM. Effect of Basal Metabolic Rate on Cancer: A Mendelian Randomization Study. Front Genet. 2021 Sep 9;12:735541. doi: 10.3389/fgene.2021.735541. eCollection 2021.
PubMed 34567085
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Sevoflurane Consumption With Metabolic Age
- ClinicalTrials.gov ID
- NCT06018597
- Acronym / sponsor ID
- Inonu 2022/92
- Conditions
- Sevoflurane
- Keywords
- Sevoflurane Consumption, Metabolic Age, Tanita
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- 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.
The aim of this clinical study is to determine the consumption of sevoflurane, which is one of the inhalation anesthetics, with metabolic age and basal metabolic rate. The basal metabolic rates and metabolic ages of the patients who will be given sevoflurane- maintained general anesthesia were measured preoperatively. The relationship between the amount of sevoflurane consumption and the measured data of the patients in the postoperative period was examined.
Detailed description
Standard monitoring, BIS, TOF (train of four) were performed from the premedication application. Aspect A 2000 (Aspect Medical Systems, Newton) monitor and single-chip BIS electrodes will be used for BIS. The total amount of sevoflurane consumed and MAK values of these components will be recorded. Chronological age, metabolic age, BMR, height, weight, ideal body weight, BMI, body adiposity, body fluid ratio, body fluid care, fat mass, lean body weight, muscle registered, visceral adiposity, obesity degree in the preoperative period of the patients. Values, ASA scores and demographic data will be recorded for the operation process, cutting time, anesthesia time, extubation time, total sevoflurane consumption throughout the case, and the relationship with basal metabolism and metabolic age will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| percent age difference < -6.6% | – | Drug: Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mLThe percentage age difference in the negative direction represents patients whose metabolic age is greater than their chronological age. When we analyze the ROC analysis in the negative direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percentage age difference is -6,6%. This group refers to those whose percentage age difference is less than -6.6% |
| percent age difference -6.6% to 11.7% those between | – | Drug: Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mLWhen we analyze the ROC analysis in the negative direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percentage age difference is -6,6%. When we analyze the ROC analysis in the positive direction, the cut-off value of the percent age difference is 11.7%. This group refers to those whose percentage age difference between -6.6% and 11.7% |
| percent age difference > 11.7% | – | Drug: Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mLthe percent age difference in the positive direction represents patients whose metabolic age is less than their chronological age. When we analyze the ROC analysis in the positive direction,between Percent Age Difference and Sevoflurane Consumption Amount Calculated According to Metabolic Age, the cut-off value of the percent age difference is 11.7%. This group refers to those whose percentage age difference is more than 11.7% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-65 AGE
Key inclusion criteria (3 listed)
- Between the ages of 18-65 who are scheduled for rhinoplasty or septoplasty with ASA I-II Cases lasting 1 to 3 hours
- Patients at high risk of malignant hyperthermia, with a history of allergy to general anesthesia or any of the drugs to be used in the study, accepted as ASA III- ASA IV
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Sevoflurane Baxter, 100%, Inhalation Vapour, Liquid 250 mLAlso: No procedure was performed on the patient other than routine anesthesia management.No procedure was performed on the patient other than routine anesthesia management.We compared sevoflurane consumption amount in the patient undergoing general anesthesia with sevoflurane according to their metabolic age. | Drug | percent age difference -6.6% to 11.7% those between, percent age difference < -6.6%, percent age difference > 11.7% |
Primary outcome
consumption of sevoflurane
Time frame: patients during surgery
Reducing patients' consumption of sevoflurane according to metabolic law
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Background: PubMed 20004080St-Onge MP, Gallagher D. Body composition changes with aging: the cause or the result of alterations in metabolic rate and macronutrient oxidation? Nutrition. 2010 Feb;26(2):152-5. doi: 10.1016/j.nut.2009.07.004. Epub 2009 Dec 8.
- Background: PubMed 34567085Ng JCM, Schooling CM. Effect of Basal Metabolic Rate on Cancer: A Mendelian Randomization Study. Front Genet. 2021 Sep 9;12:735541. doi: 10.3389/fgene.2021.735541. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sevoflurane, 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 3 inclusion and 0 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: finished, as of the sponsor's last update on 30 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption of sevoflurane (time frame: patients during surgery). 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 NCT06018597, 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 30 Aug 2023.