Minimal Flow AnesthesiaNCT06520943
Comparison of Minimum Flow and Low Flow Desflurane Anesthesia in Robotic Assisted Laparoscopic Abdominal Surgery
An observational study of Minimal Flow Anesthesia and Low Flow Anesthesia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the use of low fresh gas flow (1 L/min) desflurane anesthesia with minimum fresh gas flow (0.5 L/min) desflurane anesthesia in patients undergoing robotic-assisted abdominal surgery. The comparison will be based on hemodynamic and respiratory parameters. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Minimal Flow Anesthesia, Low Flow Anesthesia, Robotic Assisted Laparoscopic Abdominal Surgery
- What is being tested?
- blood gas analysis
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2024to 31 Dec 2024
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing robotic-assisted abdominal surgery
Who may be able to join
- Patients undergoing robotic-assisted abdominal surgery
Who cannot join
- serious cardiac, respiratory, hepatic, renal, or mental disorders;
- hearing problems;
- anxiety, depression, or other psychiatric conditions;
- patient's request to leave the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Minimum Flow Desflurane Anesthesia With Respiratory Parameters and Blood Gas Analyses and Low Flow Desflurane Anesthesia in Robotic Assisted Laparoscopic Abdominal Surgery
This study aims to compare the use of low fresh gas flow (1 L/min) desflurane anesthesia with minimum fresh gas flow (0.5 L/min) desflurane anesthesia in patients undergoing robotic-assisted abdominal surgery. The comparison will be based on hemodynamic and respiratory parameters. The secondary aim of our study is to compare the two different fresh gas flow methods in terms of inhalation agent consumption and soda lime consumption.
- Conditions
- Minimal Flow Anesthesia, Low Flow Anesthesia, Robotic Assisted Laparoscopic Abdominal Surgery
- Being tested
- blood gas analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood gas analysisOther
- Airway pressure (P plateau, Ppeak) values are taken from the anesthesia device data,
- BIS (from routine BIS monitoring)
- Temperature (routinely from pharyngeal temperature probe),
- Oxygen saturation (routinely from the patient monitor)
- End-tidal CO₂,
- inspiratory O₂ concentration,
- Inspiratory CO2 concentration,
- inspiratory and expiratory desflurane concentrations,
- tidal volume,
- MAC is routinely obtained from anesthesia device data.
- Blood Gas Analysis (COHgb, Ph, PO2, PCO2, SaO2, HCO3, Base deficit, glucose, lactate)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | After intubation, a fresh gas flow of 3 L/min will be applied for the first 20 minutes and then reduced to 0.5 L/min. Receives: Other: blood gas analysis | |
| Group 2 | After intubation, a fresh gas flow of 3 L/min will be applied for the first 20 minutes and then reduced to 1 L/min. Receives: Other: blood gas analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
inspiratory O2 concentration
inspiratory O2 concentration is measured from anesthesia machine monitor
Measured: from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
partial oxygen pressure
PO2 from blood gas analysis
Measured: from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
Secondary outcomes (2)
desflurane consumption
desflurane consumption
Measured: 3th hour
changes in liver and kidney function tests from the preoperative values to 48 hours postoperative
to determine the changes in serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN), and creatinine from the preoperative values to 48 hours postoperative
Measured: postoperative 1st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimal Flow AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
- Investigators
- Betül Güven Aytaç, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520943
- Sponsor's protocol ID
- TABED1-24-72
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Minimum Flow Desflurane Anesthesia With Respiratory Parameters and Blood Gas Analyses and Low Flow Desflurane Anesthesia in Robotic Assisted Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06520943
- Acronym / sponsor ID
- TABED1-24-72
- Conditions
- Minimal Flow Anesthesia, Low Flow Anesthesia, Robotic Assisted Laparoscopic Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Jul 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.
This study aims to compare the use of low fresh gas flow (1 L/min) desflurane anesthesia with minimum fresh gas flow (0.5 L/min) desflurane anesthesia in patients undergoing robotic-assisted abdominal surgery. The comparison will be based on hemodynamic and respiratory parameters. The secondary aim of our study is to compare the two different fresh gas flow methods in terms of inhalation agent consumption and soda lime consumption.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: blood gas analysisAfter intubation, a fresh gas flow of 3 L/min will be applied for the first 20 minutes and then reduced to 0.5 L/min. |
| Group 2 | – | Other: blood gas analysisAfter intubation, a fresh gas flow of 3 L/min will be applied for the first 20 minutes and then reduced to 1 L/min. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing robotic-assisted abdominal surgery
Key inclusion criteria (1 listed)
- Patients undergoing robotic-assisted abdominal surgery
Key exclusion criteria (4 listed)
- serious cardiac, respiratory, hepatic, renal, or mental disorders;
- hearing problems;
- anxiety, depression, or other psychiatric conditions;
- patient's request to leave the study
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 |
|---|---|---|
| blood gas analysis1. Airway pressure (P plateau, Ppeak) values are taken from the anesthesia device data, 2. BIS (from routine BIS monitoring) 3. Temperature (routinely from pharyngeal temperature probe), 4. Oxygen saturation (routinely from the patient monitor) 5. End-tidal CO₂, 6. inspiratory O₂ concentration, 7. Inspiratory CO2 concentration, 8. inspiratory and expiratory desflurane concentrations, 9. tidal volume, 10. MAC is routinely obtained from anesthesia device data. 11. Blood Gas Analysis (COHgb, Ph, PO2, PCO2, SaO2, HCO3, Base deficit, glucose, lactate) | Other | Group 1, Group 2 |
Primary outcome
inspiratory O2 concentration
Time frame: from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
inspiratory O2 concentration is measured from anesthesia machine monitor
partial oxygen pressure
Time frame: from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)
PO2 from blood gas analysis
2 secondary outcomes
desflurane consumption
Time frame: 3th hour
changes in liver and kidney function tests from the preoperative values to 48 hours postoperative
Time frame: postoperative 1st day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Not yet recruiting
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Prostate Cancer, 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.
Betül Güven Aytaç principal investigator
Ankara City Hospital Bilkent
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 Minimal Flow Anesthesia and Low Flow Anesthesia, run by Ankara City Hospital Bilkent 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: status not confirmed, as of the sponsor's last update on 25 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Betül Güven Aytaç (+903125662200, drbguven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inspiratory O2 concentration (time frame: from beginning of anesthesia induction to the end of anesthesia (during periopertaive period)). 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 25 Jul 2024.