Anesthetics, InhalationNCT03015350
Blood Levels of Sevoflurane and Desflurane
An observational study of Anesthetics, Inhalation, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
16 patients with American Society of AnesthesioIogy (ASA) physical status I-III will recruited to this study. Patients will divided to the 2 groups. %1.5 Sevoflurane will apply in Group S and %6 Desflurane will apply in Group D. Each groups will divide 2 subgroups. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Anesthetics, Inhalation
- What is being tested?
- Sevoflurane and Desflurane
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2016to Dec 2017
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 16 patients with ASA I-III who undergo thoracotomy or abdominal surgery
Who may be able to join
- Who undergo thoracotomy or abdominal surgery
Who cannot join
- ASA IV and up patients
- Patients who taken inotropic agent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ebru Biricik
Adana, In the USA Or Canada, Please Select..., 01380
About this study
Official title: Blood Levels of Sevoflurane and Desflurane During One Lung Ventilation
16 patients with American Society of AnesthesioIogy (ASA) physical status I-III will recruited to this study. Patients will divided to the 2 groups. %1.5 Sevoflurane will apply in Group S and %6 Desflurane will apply in Group D. Each groups will divide 2 subgroups. Two lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be performed to Group Sb and Group Db. At the time point 40.minutes first blood sample will given from patients. Blood sample will be taken at intervals of 10 minutes from groups of two lung ventilation. In groups of one lung ventilation, blood samples will be taken at the time interval of 10 minutes after one lung ventilation started. All blood samples will be assess in Gas Chromatography.
Read the detailed description
Investigator aimed to assess blood level of sevoflurane and desflurane during two lung ventilation and one lung ventilation. The investigators will use Gas Chromatography for define drugs levels. 16 patients with ASA I-III patients who undergo thoracotomy and abdominal surgery will be recruited to this study. Patients will divided in to the 2 groups. %1.5 Sevoflurane will apply in Group S and %6 Desflurane will apply in Group D during anesthesia maintenance. Each groups will divide 2 subgroups which are one lung ventilation groups and two lung ventilation groups. Two lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be performed to Group Sb and Group Db. Sequential blood samples will be taken from both arterial and central venous canula at the same time point. First blood samples will be taken at 40. minutes of anesthesia. Sequential samples will be taken at interval of 10 minutes during two lung ventilation. In one lung ventilation second blood samples will be taken at the 10. minutes of one lung ventilation. After than at the interval of 10 minutes, collection of blood samples both arterial and central venous will be continue.
All collection will assess with gas chromatography.
- Conditions
- Anesthetics, Inhalation
- Being tested
- Sevoflurane, Desflurane
- Keywords
- blood sevoflurane concentration, blood desflurane concentration, one lung ventilation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Blood sevoflurane level
Measurement of blood desflurane level during one lung ventilation
DesfluraneDrug
Also called Blood desflurane level
Measurement of blood desflurane level during one lung ventilation
| Study group | Role | What they receive |
|---|---|---|
| two lung ventilation of Sevoflurane | In GroupSa, 1,5 % sevoflurane will be apply continuously and blood samples will be taken at intervals of 10 minutes starting from the 40th minute. Receives: Drug: Sevoflurane | |
| one lung ventilation of Sevoflurane | In GroupSa, 1,5 % sevoflurane will be apply continuously and first samples will taken at the 40. minutes and collection of blood samples will be continue at intervals of 10 minutes after one lung ventilation started. Receives: Drug: Sevoflurane | |
| two lung ventilation of Desflurane | In GroupSa, 6 % desflurane will be apply continuously and blood samples will be taken at intervals of 10 minutes starting from the 40th minute. Receives: Drug: Desflurane | |
| one lung ventilation of desflurane | In GroupSa, 6 % desflurane will be apply continuously and first samples will taken at the 40. minutes and collection of blood samples will be continue at intervals of 10 minutes after one lung ventilation started. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of blood levels of Sevoflurane and Desflurane
Data collections will be ensured from arterial and venous blood sample and than samples will be assessed with gas chromatography and blood sevoflurane and desflurane level will be measured. Blood samples will take every 10 minutes. Only blood levels of sevoflurane and desflurane will be assessed.
Measured: from 40th minute to the end of the operation
Secondary outcomes (1)
determine of ventilation-perfusion mismatch with p(A-a)O2
During one lung ventilation, p(a-A)O2 will be assessed with arterial blood analyses
Measured: from 40th minute to the end of the one lung ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthetics, InhalationStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru biricik, Cukurova University
- Investigators
- Ebru Biricik, MD, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015350
- Sponsor's protocol ID
- One lung ventilation
- Status last verified
- Nov 2017
- First submitted
- 27 Dec 2016
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Levels of Sevoflurane and Desflurane During One Lung Ventilation
- ClinicalTrials.gov ID
- NCT03015350
- Acronym / sponsor ID
- One lung ventilation
- Conditions
- Anesthetics, Inhalation
- Keywords
- blood sevoflurane concentration, blood desflurane concentration, one lung ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Jan 2017 (estimated)
- 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.
16 patients with American Society of AnesthesioIogy (ASA) physical status I-III will recruited to this study. Patients will divided to the 2 groups. %1.5 Sevoflurane will apply in Group S and %6 Desflurane will apply in Group D. Each groups will divide 2 subgroups. Two lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be performed to Group Sb and Group Db. At the time point 40.minutes first blood sample will given from patients. Blood sample will be taken at intervals of 10 minutes from groups of two lung ventilation. In groups of one lung ventilation, blood samples will be taken at the time interval of 10 minutes after one lung ventilation started. All blood samples will be assess in Gas Chromatography.
Detailed description
Investigator aimed to assess blood level of sevoflurane and desflurane during two lung ventilation and one lung ventilation. The investigators will use Gas Chromatography for define drugs levels. 16 patients with ASA I-III patients who undergo thoracotomy and abdominal surgery will be recruited to this study. Patients will divided in to the 2 groups. %1.5 Sevoflurane will apply in Group S and %6 Desflurane will apply in Group D during anesthesia maintenance. Each groups will divide 2 subgroups which are one lung ventilation groups and two lung ventilation groups. Two lung ventilation will be performed to Group Sa and Group Da, one lung ventilation will be performed to Group Sb and Group Db. Sequential blood samples will be taken from both arterial and central venous canula at the same time point. First blood samples will be taken at 40. minutes of anesthesia. Sequential samples will be taken at interval of 10 minutes during two lung ventilation. In one lung ventilation second blood samples will be taken at the 10. minutes of one lung ventilation. After than at the interval of 10 minutes, collection of blood samples both arterial and central venous will be continue.
All collection will assess with gas chromatography.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| two lung ventilation of Sevoflurane | – | Drug: SevofluraneIn GroupSa, 1,5 % sevoflurane will be apply continuously and blood samples will be taken at intervals of 10 minutes starting from the 40th minute. |
| one lung ventilation of Sevoflurane | – | Drug: SevofluraneIn GroupSa, 1,5 % sevoflurane will be apply continuously and first samples will taken at the 40. minutes and collection of blood samples will be continue at intervals of 10 minutes after one lung ventilation started. |
| two lung ventilation of Desflurane | – | Drug: DesfluraneIn GroupSa, 6 % desflurane will be apply continuously and blood samples will be taken at intervals of 10 minutes starting from the 40th minute. |
| one lung ventilation of desflurane | – | Drug: DesfluraneIn GroupSa, 6 % desflurane will be apply continuously and first samples will taken at the 40. minutes and collection of blood samples will be continue at intervals of 10 minutes after one lung ventilation started. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 16 patients with ASA I-III who undergo thoracotomy or abdominal surgery
Key inclusion criteria (1 listed)
- Who undergo thoracotomy or abdominal surgery
Key exclusion criteria (2 listed)
- ASA IV and up patients
- Patients who taken inotropic agent
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 |
|---|---|---|
| SevofluraneAlso: Blood sevoflurane levelMeasurement of blood desflurane level during one lung ventilation | Drug | one lung ventilation of Sevoflurane, two lung ventilation of Sevoflurane |
| DesfluraneAlso: Blood desflurane levelMeasurement of blood desflurane level during one lung ventilation | Drug | one lung ventilation of desflurane, two lung ventilation of Desflurane |
Primary outcome
Measurement of blood levels of Sevoflurane and Desflurane
Time frame: from 40th minute to the end of the operation
Data collections will be ensured from arterial and venous blood sample and than samples will be assessed with gas chromatography and blood sevoflurane and desflurane level will be measured. Blood samples will take every 10 minutes. Only blood levels of sevoflurane and desflurane will be assessed.
1 secondary outcome
determine of ventilation-perfusion mismatch with p(A-a)O2
Time frame: from 40th minute to the end of the one lung ventilation
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 5 Mar 2018.
- 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.
Ebru Biricik, MD principal investigator
Cukurova University
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 Anesthetics, Inhalation, run by Cukurova 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 1 inclusion and 2 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 5 Mar 2018. 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?
Measurement of blood levels of Sevoflurane and Desflurane (time frame: from 40th minute to the end of the operation). 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 5 Mar 2018.