OxygenationNCT06118489
Effects of Different Anesthetic Gases on Hemodynamics, Arterial Oxygenation and Pulmonary Mechanics
An observational study of Oxygenation and Spinal Surgery, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
The bronchodilator effects of volatile anesthetics have been the subject of many clinical studies. It is known that all volatile anesthetics, especially halothane, have similar effects. Sevoflurane has been shown to reduce airway resistance more than halothane and isoflurane. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygenation, Spinal Surgery, Sevoflurane
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Feb 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: ASA 1-2 patients between the ages of 18 and 65 who are scheduled for spinal surgery will be included in the study.
Who may be able to join
- 18-65 years old
- ASA1-2
- Patients planned to undergo spinal surgery
Who cannot join
- 1 - Lung disease
- BMI 35 and above
- Smokers
- Those under the age of 18 and over the age of 65
- Hepatorenal disease
- Reynaud's disease
Show all 11Show fewer
- Burger disease
- Hypotensive patient
- Neuromuscular disease
- Those who have had thoracic surgery before
- Those with bad Allen test results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Different Anesthetic Gases on Hemodynamics, Arterial Oxygenation and Pulmonary Mechanics in Spinal Surgery.
The bronchodilator effects of volatile anesthetics have been the subject of many clinical studies. It is known that all volatile anesthetics, especially halothane, have similar effects. Sevoflurane has been shown to reduce airway resistance more than halothane and isoflurane. Desflurane is difficult to use as an induction agent due to its harsh and extremely pungent odor and airway irritating effect. However, it has been shown that the risk of cough, respiratory arrest and laryngospasm is no different from sevoflurane when administered after intravenous induction. Although it irritates the airway, it is thought to have a bronchodilation effect as it stimulates the sympathetic system.
In spinal surgeries, prone position is required to access the operating field. When the patient is placed in the prone position, pulmonary physiology are affected. In the prone position, V/Q mismatch decreases and arterial oxygenation increases. However, lung compliance decreases and the peak inspiratory pressure required to reach the required tidal volume increases. The main purpose of this study is the effect of volatile agents on lung mechanics and oxygenisation in the prone position.
- Conditions
- Oxygenation, Spinal Surgery, Sevoflurane, Desflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Not described | |
| desflurane | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance
pulmonary compliance before, during and after prone position
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OxygenationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yadigar Yılmaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118489
- Sponsor's protocol ID
- HamidiyeKAEK-98172
- Status last verified
- Jun 2025
- First submitted
- 31 Oct 2023
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Anesthetic Gases on Hemodynamics, Arterial Oxygenation and Pulmonary Mechanics in Spinal Surgery.
- ClinicalTrials.gov ID
- NCT06118489
- Acronym / sponsor ID
- HamidiyeKAEK-98172
- Conditions
- Oxygenation, Spinal Surgery, Sevoflurane, Desflurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 7 Nov 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 bronchodilator effects of volatile anesthetics have been the subject of many clinical studies. It is known that all volatile anesthetics, especially halothane, have similar effects. Sevoflurane has been shown to reduce airway resistance more than halothane and isoflurane. Desflurane is difficult to use as an induction agent due to its harsh and extremely pungent odor and airway irritating effect. However, it has been shown that the risk of cough, respiratory arrest and laryngospasm is no different from sevoflurane when administered after intravenous induction. Although it irritates the airway, it is thought to have a bronchodilation effect as it stimulates the sympathetic system.
In spinal surgeries, prone position is required to access the operating field. When the patient is placed in the prone position, pulmonary physiology are affected. In the prone position, V/Q mismatch decreases and arterial oxygenation increases. However, lung compliance decreases and the peak inspiratory pressure required to reach the required tidal volume increases. The main purpose of this study is the effect of volatile agents on lung mechanics and oxygenisation in the prone position.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | – | – |
| desflurane | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ASA 1-2 patients between the ages of 18 and 65 who are scheduled for spinal surgery will be included in the study.
Key inclusion criteria (3 listed)
- 18-65 years old
- ASA1-2
- Patients planned to undergo spinal surgery
Key exclusion criteria (11 listed)
- 1 - Lung disease
- BMI 35 and above
- Smokers
- Those under the age of 18 and over the age of 65
- Hepatorenal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
compliance
Time frame: 2 hour
pulmonary compliance before, during and after prone position
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 10 Jun 2025.
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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 Oxygenation and Spinal Surgery, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 11 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 10 Jun 2025. 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?
compliance (time frame: 2 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.