Low Flow AnesthesiaNCT03955406
Low Flow Anesthesia Without Initial High Flow Phase
A study testing Conventional Low flow Anesthesia and Low Flow Anesthesia with fixed fresh gas flow rate in people with Low Flow Anesthesia and Volatile Anesthetic Consumption, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to compare the effectiveness of conventional low flow anesthesia (LFA) with initial high fresh gas flow ( 4L/min) for 10 minutes and LFA with fixed fresh gas flow rate (1L/min). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Flow Anesthesia, Volatile Anesthetic Consumption
- What is being tested?
- Conventional Low flow Anesthesia and Low Flow Anesthesia with fixed fresh gas flow rate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2019to 2 Jul 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3
- scheduled for surgery under general anesthesia with endotracheal intubation
Who cannot join
- hemodynamic instability
- emergency cases
- expected anesthesia duration < 60 min
- patient refusal
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University
Kahramanmaraş, In the USA Or Canada, Please Select..., 46100
About this study
Official title: Comparison of Low Flow Anesthesia With and Without Initial High Flow Phase
The aim of the study is to compare the effectiveness of conventional low flow anesthesia (LFA) with initial high fresh gas flow ( 4L/min) for 10 minutes and LFA with fixed fresh gas flow rate (1L/min).
- Being tested
- Conventional Low flow Anesthesia, Low Flow Anesthesia with fixed fresh gas flow rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Low flow AnesthesiaProcedure or surgery
During the initial wash-in period 4 L/min Fresh gas flow will be used.
Low Flow Anesthesia with fixed fresh gas flow rateProcedure or surgery
Fresh gas flow rate will be 1 L/min throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Conventional group | Active comparator | After standart intravenous anesthesia induction end endotracheal intubation desflurane vaporizer will be set at 6% with fresh gas flow rate 4 L/min (50% O2, 50% air) until the EtAA concentration reaches 0.7 MAC (minimum alveolar concentration) Then, the desflurane vaporizer will be at a 1% higher value than the EtAA concentration required to achieve 0.7 MAC. And after 10 minutes fresh gas flow rate will be reduced to 1L/min. Receives: Procedure: Conventional Low flow Anesthesia |
| Fixed Fresh Gas Flow Rate group | Active comparator | After standart intravenous anesthesia induction end endotracheal intubation desflurane vaporizer will be set at 18% with fresh gas flow rate 1 L/min (50% O2, 50% air) until the EtAA concentration reaches 0.7 MAC (minimum alveolar concentration) Then, the desflurane vaporizer will be at a 2% higher value than the EtAA concentration required to achieve 0.7 MAC. Receives: Procedure: Low Flow Anesthesia with fixed fresh gas flow rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time required to reach 0.7 MAC
Measured: perioperative
number of adjustments made to the vaporizer settings
MAC will be held between 0.6-0.8 with adjustments at the vaporizer
Measured: perioperative
Secondary outcomes (1)
anesthetic agent consumption
desfluane consumption at the first hour and at the end of the surgery wil be recorded
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start22 May 2019
- Primary completion2 Jul 2019
- Study completion2 Jul 2019
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MAHMUT ARSLAN, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955406
- Sponsor's protocol ID
- KSU 2017-15
- Status last verified
- Jul 2019
- First submitted
- 16 May 2019
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Low Flow Anesthesia With and Without Initial High Flow Phase
- ClinicalTrials.gov ID
- NCT03955406
- Acronym / sponsor ID
- KSU 2017-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2019 (actual)
- First posted
- 20 May 2019 (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 aim of the study is to compare the effectiveness of conventional low flow anesthesia (LFA) with initial high fresh gas flow ( 4L/min) for 10 minutes and LFA with fixed fresh gas flow rate (1L/min).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional group | Active comparator | Procedure: Conventional Low flow AnesthesiaAfter standart intravenous anesthesia induction end endotracheal intubation desflurane vaporizer will be set at 6% with fresh gas flow rate 4 L/min (50% O2, 50% air) until the EtAA concentration reaches 0.7 MAC (minimum alveolar concentration) Then, the desflurane vaporizer will be at a 1% higher value than the EtAA concentration required to achieve 0.7 MAC. And after 10 minutes fresh gas flow rate will be reduced to 1L/min. |
| Fixed Fresh Gas Flow Rate group | Active comparator | Procedure: Low Flow Anesthesia with fixed fresh gas flow rateAfter standart intravenous anesthesia induction end endotracheal intubation desflurane vaporizer will be set at 18% with fresh gas flow rate 1 L/min (50% O2, 50% air) until the EtAA concentration reaches 0.7 MAC (minimum alveolar concentration) Then, the desflurane vaporizer will be at a 2% higher value than the EtAA concentration required to achieve 0.7 MAC. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA 1-3
- scheduled for surgery under general anesthesia with endotracheal intubation
Key exclusion criteria (4 listed)
- hemodynamic instability
- emergency cases
- expected anesthesia duration < 60 min
- patient refusal
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 |
|---|---|---|
| Conventional Low flow AnesthesiaDuring the initial wash-in period 4 L/min Fresh gas flow will be used. | Procedure or surgery | Conventional group |
| Low Flow Anesthesia with fixed fresh gas flow rateFresh gas flow rate will be 1 L/min throughout the procedure. | Procedure or surgery | Fixed Fresh Gas Flow Rate group |
Primary outcome
The time required to reach 0.7 MAC
Time frame: perioperative
number of adjustments made to the vaporizer settings
Time frame: perioperative
MAC will be held between 0.6-0.8 with adjustments at the vaporizer
1 secondary outcome
anesthetic agent consumption
Time frame: perioperative
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 Jul 2019.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Low Flow Anesthesia
RecruitingObservational study
Post-Induction Low Cardiac Output Syndrome in Coronary Artery Bypass Graft Surgery
Cardiac Output, Low, Coronary Arterial Disease
RecruitingObservational study
Predictive Value of ONSD and NIRS for PDPH
Post-Dural Puncture Headache, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
Recruiting
Erector Spinae Plane Block and Low-Flow Anaesthesia in Laparoscopic Cholecystectomy
Postoperative Pain, Laparoscopic Cholecystectomy
RecruitingObservational study
Ultrasound for Postop Lung Issues in Low-Flow Anesthesia
Atelectasis, Postoperative, Cholecystitis; Gallstone
Not yet recruitingObservational study
Assessment of Sevoflurane Consumption During General Anesthesia With a Low Fresh Gas Flow Rate of 0.3 L/Min
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.
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?
A study testing Conventional Low flow Anesthesia and Low Flow Anesthesia with fixed fresh gas flow rate in people with Low Flow Anesthesia and Volatile Anesthetic Consumption, run by Kahramanmaras Sutcu Imam 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 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 10 Jul 2019. 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?
The time required to reach 0.7 MAC (time frame: perioperative). The study lists 2 primary outcomes in all. 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 Jul 2019.