- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06026033
The Effect of Anthropometrics on Desflurane Rise Time
Does Desflurane Take Longer to Reach Target Endtidal Concentration in Patients With Higher Body Muscle Content: a Pragmatic Study
Desflurane is increasingly used in general anesthesia. Its pharmacokinetic properties are known and its distribution is easily modeled. Yet these models fail in practice. In order to increase accuracy, any model should include cardiac output, alveolar ventilation and alveolar dead space, all of which are either hard to measure or impractical, at least.
A previous study performed by the same investigator showed that time to target endtidal concentration of sevoflurane is prolonged with increased cardiac output, but only if the patient has increased muscle mass. Although desflurane has lower muscle and fat solubility, our observations suggest a similar prolongation in case of increased muscle mass.
The investigators aim to investigate if patient characteristics such as gender, age, height, weight, body type prolongs time to reach target endtidal desflurane concentration in low flow anesthesia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low flow anesthesia is a frequently used application in anesthesiology practice. With the widespread use of modern anesthesia devices, the implementation of this application has become easier and its complications have been greatly reduced. It is routinely applied in our clinic, accompanied by both the protocols in the literature and the protocols the investigators have created.
Desflurane is the most recently developed inhaler anesthetic agent, and it has advantages such as faster recovery from anesthesia and less metabolism compared to sevoflurane. Although the physicochemical properties of desflurane are known, computer models for its use with low-flow anesthesia are based on desflurane's physicochemical properties, and not on the pharmacokinetic properties of patients. The inhaled induction times obtained with these models do not agree with our observations in practice.
In a study conducted in 2021, it was shown that parameters such as cardiac output and alveolar ventilation can increase the accuracy of these models. Among these models, the most frequently used one in the literature is included in the Gas Man simulator, which is also used in anesthesia specialty training. It allows one to perform studies that compare simulation-based and in vivo values are carried out.
A similar study was conducted by us with sevoflurane in 2018; A significant difference was found in the rate of increase in alveolar sevoflurane concentration according to cardiac output and muscle mass. Based on this study, the investigators aimed to investigate the effect of the patient's muscle mass evaluated by pragmatic measures such as height, body weight and body type on the rate of increase in the alveolar concentration of desflurane.
For this purpose, the investigators aimed to investigate the relationship between the time to reach the targeted alveolar desflurane gas concentration and patient characteristics. The investigators believe that the results of the study will be useful in explaining the factors affecting the induction of general anesthesia with desflurane.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rize, Turkey, 53100
- Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- age > 18 years
- planned elective surgery
- planned inhalational anesthesia
- planned use of desflurane
Exclusion Criteria:
- emergency surgery
- use of other inhalational anesthetic agent (sevoflurane, isoflurane, nitrous oxide)
- disclosed or recognized pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients scheduled for general anesthesia
Patients scheduled for elective general anesthesia will be included, if accepts and signs the informed consent.
The inhalational anesthetic should be desflurane.
No other inhalational agent should be used during the induction of anesthesia.
The inspiratory and expiratory concentration of any inhalational agent should be zero before the induction of anesthesia.
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Following tracheal intubation, the fresh gas flow will be set to 1 liters/minute, desflurane vaporizer will be set to maximum.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of rise in expiratory desflurane concentration
Time Frame: intraoperative
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Correlation between the time required for the endtidal expiratory desflurane concentration to reach 8% and patient characteristics
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intraoperative
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Rate of rise in inspiratory desflurane concentration
Time Frame: intraoperative
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Correlation between the time required for the endtidal inspiratory desflurane concentration to reach 6% and patient characteristics
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intraoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between occurrence of hypertension and patient characteristics
Time Frame: intraoperative
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Correlation between occurrence of hypertension defined as any measurement of systolic arterial blood pressure > 160 mmHg and patient characteristics
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intraoperative
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Correlation between occurrence of tachycardia and patient characteristics
Time Frame: intraoperative
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Correlation between occurrence of tachycardia defined as any measurement of heart rate > 100/minute and patient characteristics
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intraoperative
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Başar Erdivanlı, Assoc. Prof., Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
- Principal Investigator: Alihan Madran, M.D., Recep Tayyip Erdogan University Medical Faculty, Department of Anesthesiology and Reanimation
Publications and helpful links
General Publications
- Weber J, Missbach C, Schmidt J, Wenzel C, Schumann S, Philip JH, Wirth S. Prediction of expiratory desflurane and sevoflurane concentrations in lung-healthy patients utilizing cardiac output and alveolar ventilation matched pharmacokinetic models: A comparative observational study. Medicine (Baltimore). 2021 Feb 12;100(6):e23570. doi: 10.1097/MD.0000000000023570.
- Athiraman U, Ravishankar M, Jahagirdhar S. Performance of computer simulated inhalational anesthetic uptake model in comparison with real time isoflurane concentration. J Clin Monit Comput. 2016 Dec;30(6):791-796. doi: 10.1007/s10877-015-9776-6. Epub 2015 Sep 19.
- Philip JH. Using screen-based simulation of inhaled anaesthetic delivery to improve patient care. Br J Anaesth. 2015 Dec;115 Suppl 2:ii89-94. doi: 10.1093/bja/aev370.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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