Safety IssuesNCT03465475
Anesthetic Cost Analysis With Desflurane in Automated Gas Control Mode
An observational study of Safety Issues, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
Inhalation agents constitute the major part of anesthetic drug costs (20% - 25%) and a significant portion of the applied inhalation agents are thrown into the atmosphere through the waste gas system without being absorbed by the patient. The amount of waste gas is directly correlated to the fresh gas flow (FGF). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Safety Issues
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Mar 2021
- 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: Patients undergoing hepatectomy operation
Who may be able to join
- Adult patients undergoing hepatectomy with general anesthesia
Who cannot join
- Essential data missing
- Patient participating in other research projects
- Drug allergy
- Anesthetic complication story
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthetic Cost Analysis With Desflurane in Automated Gas Control Mode With Maquet Flow-i Anaesthesia Machine
Inhalation agents constitute the major part of anesthetic drug costs (20% - 25%) and a significant portion of the applied inhalation agents are thrown into the atmosphere through the waste gas system without being absorbed by the patient. The amount of waste gas is directly correlated to the fresh gas flow (FGF). Reducing the TGA during general anesthesia reduces the consumption of inhalant agents and contributes to the reduction of greenhouse gas pollution. Risks such as hypoxia, hypercapnia, inadequate depth of anesthesia and potential toxic gas accumulation were associated with low flow anesthesia, but the patient was provided with adequate safety by following pulse oximetry, capnography, FiO2 and anesthetic gas analysis. We aimed to perform anesthetic cost analysis and patient security in automated gas control mode (AGC).
Read the detailed description
After the ethical approvel 60 adult patients scheduled for hepatectomy will be taken to study. Patients will be monitored after they are taken to the operating room (ECG, NIBP, SpO2, Body Temp, BIS, NIRS, PVI, PI, ORI). After the anesthesia induction and tarakeal entubation, first twenty patient will take 300 mL fresh gas flow with AGC mode (group 1), Second twenty patient will take 600 mL fresh gas flow with AGC mode (group 2), third twenty patient will take 600 mL fresh gas flow with manually. Hemodynamic and gas consumption data will be recorded. An operating room will be reserved for this study.
- Conditions
- Safety Issues
- Keywords
- Low flow anesthesia, Desflurane, Cost analysis, Automated gas control
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 |
|---|---|---|
| Group 1 | The patient who receive 300 mL fresh gas flow with AGC mode during the general anesthesia | |
| Group 2 | The patient who receive 600 mL fresh gas flow with AGC mode during the general anesthesia | |
| Group 3 | The patient who receive 600 mL fresh gas flow with manuelly during the general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of used anesthetic gas (desflurane)
Amount of used desflurane will be determined in milliliter by anesthesia machine (Maquet Flow i40) for each patient.
Measured: Through study completion, an average of 2 month
Secondary outcomes (3)
Heart rate
Heart rate/min
Measured: Through study completion, an average of 2 month
Mean arterial pressure
Mean arterial pressure (mm/Hg)
Measured: Through study completion, an average of 2 month
Peripheral oxygen saturation
Peripheral oxygen saturation (%)
Measured: Through study completion, an average of 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start1 Jul 2018
- Primary completion30 Oct 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Ziya ÇOLAK, Inonu University
- Investigators
- Yusuf Z Çolak, MD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465475
- Sponsor's protocol ID
- Inonu uni
- Status last verified
- Aug 2021
- First submitted
- 1 Feb 2018
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Cost Analysis With Desflurane in Automated Gas Control Mode With Maquet Flow-i Anaesthesia Machine
- ClinicalTrials.gov ID
- NCT03465475
- Acronym / sponsor ID
- Inonu uni
- Conditions
- Safety Issues
- Keywords
- Low flow anesthesia, Desflurane, Cost analysis, Automated gas control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 14 Mar 2018 (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.
Inhalation agents constitute the major part of anesthetic drug costs (20% - 25%) and a significant portion of the applied inhalation agents are thrown into the atmosphere through the waste gas system without being absorbed by the patient. The amount of waste gas is directly correlated to the fresh gas flow (FGF). Reducing the TGA during general anesthesia reduces the consumption of inhalant agents and contributes to the reduction of greenhouse gas pollution. Risks such as hypoxia, hypercapnia, inadequate depth of anesthesia and potential toxic gas accumulation were associated with low flow anesthesia, but the patient was provided with adequate safety by following pulse oximetry, capnography, FiO2 and anesthetic gas analysis. We aimed to perform anesthetic cost analysis and patient security in automated gas control mode (AGC).
Detailed description
After the ethical approvel 60 adult patients scheduled for hepatectomy will be taken to study. Patients will be monitored after they are taken to the operating room (ECG, NIBP, SpO2, Body Temp, BIS, NIRS, PVI, PI, ORI). After the anesthesia induction and tarakeal entubation, first twenty patient will take 300 mL fresh gas flow with AGC mode (group 1), Second twenty patient will take 600 mL fresh gas flow with AGC mode (group 2), third twenty patient will take 600 mL fresh gas flow with manually. Hemodynamic and gas consumption data will be recorded. An operating room will be reserved for this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –The patient who receive 300 mL fresh gas flow with AGC mode during the general anesthesia |
| Group 2 | – | –The patient who receive 600 mL fresh gas flow with AGC mode during the general anesthesia |
| Group 3 | – | –The patient who receive 600 mL fresh gas flow with manuelly during the general anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing hepatectomy operation
Key inclusion criteria (1 listed)
- Adult patients undergoing hepatectomy with general anesthesia
Key exclusion criteria (4 listed)
- Essential data missing
- Patient participating in other research projects
- Drug allergy
- Anesthetic complication story
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
Amount of used anesthetic gas (desflurane)
Time frame: Through study completion, an average of 2 month
Amount of used desflurane will be determined in milliliter by anesthesia machine (Maquet Flow i40) for each patient.
3 secondary outcomes
Heart rate
Time frame: Through study completion, an average of 2 month
Mean arterial pressure
Time frame: Through study completion, an average of 2 month
Peripheral oxygen saturation
Time frame: Through study completion, an average of 2 month
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 25 Aug 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.
Yusuf Z Çolak, MD principal investigator
Investigator
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 Safety Issues, 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 1 inclusion and 4 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 25 Aug 2021. 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?
Amount of used anesthetic gas (desflurane) (time frame: Through study completion, an average of 2 month). 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 25 Aug 2021.