Low-flow AnesthesiaNCT06735937
The Effects of Automatic Gas-Controlled Low-Flow Anesthesia on Anesthetic Agent Consumption in Elective Surgeries
A study testing Low flow anesthesia in people with Low-flow Anesthesia, run by University of Gaziantep at 1 site in Turkey (Türkiye).
Trial summary
In this study, we aim to compare the effects of end-tidal controlled and manually controlled low-flow anesthesia on anesthetic agent consumption in elective surgeries. Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Low-flow Anesthesia
- What is being tested?
- Low flow anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 31 Aug 2020
- Phase
- Interventional
- 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 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- Aged between18-73
Who cannot join
- heart failure
- liver disease
- lung disease
- kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Automatic Gas-Controlled Low-Flow Anesthesia on Anesthetic Agent Consumption in Elective Surgeries: Randomized Controlled Study
In this study, we aim to compare the effects of end-tidal controlled and manually controlled low-flow anesthesia on anesthetic agent consumption in elective surgeries.
Read the detailed description
In this study, we aim to compare the effects of end-tidal controlled and manually controlled low-flow anesthesia on anesthetic agent consumption in elective surgeries. This evaluation will contribute to understanding whether automated systems provide measurable advantages in clinical settings.This evaluation will contribute to understanding whether automated systems provide measurable advantages in clinical settings.
- Conditions
- Low-flow Anesthesia
- Being tested
- Low flow anesthesia
- Keywords
- end-tidal controlled, low flow anesthesia, consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flow anesthesiaOther
Anesthesia management by using low flow anesthesia
| Study group | Role | What they receive |
|---|---|---|
| End-tidal controlled | Experimental | Patients ventilated using end tidal controlled low-flow anesthesia Receives: Other: Low flow anesthesia |
| Manually controlled | Experimental | Patients ventilated using manually controlled low flow anesthesia Receives: Other: Low flow anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
anesthesic gas consumption
Measured: At the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start1 Sep 2019
- Primary completion1 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-flow AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elzem SEN, University of Gaziantep
- Investigators
- Elzem Sen, Assoc Prof, Principal investigator, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735937
- Sponsor's protocol ID
- 2019/355
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- 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 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Automatic Gas-Controlled Low-Flow Anesthesia on Anesthetic Agent Consumption in Elective Surgeries: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06735937
- Acronym / sponsor ID
- 2019/355
- Conditions
- Low-flow Anesthesia
- Keywords
- end-tidal controlled, low flow anesthesia, consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 16 Dec 2024 (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.
In this study, we aim to compare the effects of end-tidal controlled and manually controlled low-flow anesthesia on anesthetic agent consumption in elective surgeries.
Detailed description
In this study, we aim to compare the effects of end-tidal controlled and manually controlled low-flow anesthesia on anesthetic agent consumption in elective surgeries. This evaluation will contribute to understanding whether automated systems provide measurable advantages in clinical settings.This evaluation will contribute to understanding whether automated systems provide measurable advantages in clinical settings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End-tidal controlled | Experimental | Other: Low flow anesthesiaPatients ventilated using end tidal controlled low-flow anesthesia |
| Manually controlled | Experimental | Other: Low flow anesthesiaPatients ventilated using manually controlled low flow anesthesia |
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II
- Aged between18-73
Key exclusion criteria (4 listed)
- heart failure
- liver disease
- lung disease
- kidney disease
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 |
|---|---|---|
| Low flow anesthesiaAnesthesia management by using low flow anesthesia | Other | End-tidal controlled, Manually controlled |
Primary outcome
anesthesic gas consumption
Time frame: At the end of the surgery
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 16 Dec 2024.
- Individual participant dataSharing planned: No
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Anesthesia
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.
Elzem Sen, Assoc Prof principal investigator
University of Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low flow anesthesia in people with Low-flow Anesthesia, run by University of Gaziantep 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 2 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 16 Dec 2024. 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?
anesthesic gas consumption (time frame: At the end of the surgery). 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 16 Dec 2024.