Hemodynamics InstabilityNCT06871371
Low and Moderete Flow Anaesthesia on Haemodynamics
A study testing Sevoflurane (Volatile Anesthetic) and low- medium flow anesthetic machine in people with Hemodynamics Instability and Arrhythmias Cardiac, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study topic investigates the potential advantages of low-flow anesthesia in terms of physiological protection and resource saving. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Hemodynamics Instability, Arrhythmias Cardiac, Cerebral Oxygenation
- What is being tested?
- Sevoflurane (Volatile Anesthetic) and low- medium flow anesthetic machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2025to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- being ASA1-2 status
- between the ages of 18-70
- who are planned for laparoscopic cholecystectomy
Who cannot join
- Patients who refuse to give informed consent
- Pregnant and breastfeeding patients
- Morbidly obese patients (Body mass index over 40)
- Patients with uncontrolled diabetes mellitus, with serious cardiovascular, pulmonary, renal, hepatic disease, obstructive sleep apnea, with electrolyte imbalance- Those with a history of alcohol or drug abuse, with perioperative hemodynamic instability
- Patients using drugs known to prolong myocardial repolarization
- inability to increase SPO2 above 95 despite necessary intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Umraniye Education and research hospital
Istanbul, 34111
About this study
Official title: The Comparison of the Effects of Low and Medium Flow Anesthesia on Haemodynamics, Arrhytmia Risk and Cerebral Oxygenation in Laparoscopic Cholecystomy Cases
The study topic investigates the potential advantages of low-flow anesthesia in terms of physiological protection and resource saving.
Read the detailed description
The study aims to compare the effects of low and normal flow sevoflurane anesthesia on the frontal QRS-T angle and cerebral oxygenation in laparoscopic cholecystectomy surgery. The primary objective was to evaluate the effects of low-flow anesthesia on hemodynamic stability and arrhythmia risk; the secondary objective was to compare the total sevoflurane consumption in both methods.
- Being tested
- Sevoflurane (Volatile Anesthetic), low- medium flow anesthetic machine
- Keywords
- Low-Medium Flow Anesthesia, Hemodynamics, Oxygenation
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane (Volatile Anesthetic)Device
Both groups will be given sevoflurane and one group will be given low current anesthesia and the other group will be given medium flow anesthesia.
low- medium flow anesthetic machineDevice
The study aims to compare the effects of low and normal flow sevoflurane anesthesia on the frontal QRS-T angle and cerebral oxygenation in laparoscopic cholecystectomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| low flow anesthesia | Active comparator | Maintenance of anaesthesia with low-flow anaesthesia Receives: Device: Sevoflurane (Volatile Anesthetic); Device: low- medium flow anesthetic machine |
| Medium Flow Anesthesia | Active comparator | Maintenance of anaesthesia with medium-flow anaesthesia Receives: Device: Sevoflurane (Volatile Anesthetic); Device: low- medium flow anesthetic machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effects of low-flow anesthesia on hemodynamic stability
The primary objective was to detect the adverse effects of low-flow anesthesia on hemodynamic stability and arrhythmia risk
Measured: in 2 months
Secondary outcomes (1)
the cerebral oxygenation
The primary objective was to detect the adverse effects of low-flow anesthesia on cerebral oxygenation
Measured: in 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamics InstabilityStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Senay Goksu, Umraniye Education and Research Hospital
- Investigators
- SENAY GOKSU, MD, Principal investigator, UMRANIYE E R HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871371
- Sponsor's protocol ID
- LFATUGCE
- Status last verified
- Mar 2025
- First submitted
- 26 Jan 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Effects of Low and Medium Flow Anesthesia on Haemodynamics, Arrhytmia Risk and Cerebral Oxygenation in Laparoscopic Cholecystomy Cases
- ClinicalTrials.gov ID
- NCT06871371
- Acronym / sponsor ID
- LFATUGCE
- Keywords
- Low-Medium Flow Anesthesia, Hemodynamics, Oxygenation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 11 Mar 2025 (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 study topic investigates the potential advantages of low-flow anesthesia in terms of physiological protection and resource saving.
Detailed description
The study aims to compare the effects of low and normal flow sevoflurane anesthesia on the frontal QRS-T angle and cerebral oxygenation in laparoscopic cholecystectomy surgery. The primary objective was to evaluate the effects of low-flow anesthesia on hemodynamic stability and arrhythmia risk; the secondary objective was to compare the total sevoflurane consumption in both methods.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low flow anesthesia | Active comparator | Device: Sevoflurane (Volatile Anesthetic), Device: low- medium flow anesthetic machineMaintenance of anaesthesia with low-flow anaesthesia |
| Medium Flow Anesthesia | Active comparator | Device: Sevoflurane (Volatile Anesthetic), Device: low- medium flow anesthetic machineMaintenance of anaesthesia with medium-flow anaesthesia |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- being ASA1-2 status
- between the ages of 18-70
- who are planned for laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- Patients who refuse to give informed consent
- Pregnant and breastfeeding patients
- Morbidly obese patients (Body mass index over 40)
- Patients with uncontrolled diabetes mellitus, with serious cardiovascular, pulmonary, renal, hepatic disease, obstructive sleep apnea, with electrolyte imbalance- Those with a history of alcohol or drug abuse, with perioperative hemodynamic instability
- Patients using drugs known to prolong myocardial repolarization
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 |
|---|---|---|
| Sevoflurane (Volatile Anesthetic)Both groups will be given sevoflurane and one group will be given low current anesthesia and the other group will be given medium flow anesthesia. | Device | Medium Flow Anesthesia, low flow anesthesia |
| low- medium flow anesthetic machineThe study aims to compare the effects of low and normal flow sevoflurane anesthesia on the frontal QRS-T angle and cerebral oxygenation in laparoscopic cholecystectomy surgery. | Device | Medium Flow Anesthesia, low flow anesthesia |
Primary outcome
the effects of low-flow anesthesia on hemodynamic stability
Time frame: in 2 months
The primary objective was to detect the adverse effects of low-flow anesthesia on hemodynamic stability and arrhythmia risk
1 secondary outcome
the cerebral oxygenation
Time frame: in 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 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.
SENAY GOKSU, MD principal investigator
UMRANIYE E R HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane (Volatile Anesthetic) and low- medium flow anesthetic machine in people with Hemodynamics Instability and Arrhythmias Cardiac, run by Umraniye Education and Research Hospital 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 6 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: opening soon, as of the sponsor's last update on 11 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact senay goksu, specialist doctor (+905337144852, senaytomruk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effects of low-flow anesthesia on hemodynamic stability (time frame: in 2 months). 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 11 Mar 2025.