Low-flow AnesthesiaNCT06676969
High vs. Low Flow Sevoflurane Anesthesia in Pediatric Laparoscopic Surgery: Recovery, Hemodynamics, and Cost Comparison
An observational study of Low-flow Anesthesia, run by Ondokuz Mayıs University at 2 sites in Turkey (Türkiye).
Trial summary
The primary objective of our study is to compare the effects of different flow rates of the routinely used inhalation agent, sevoflurane, on postoperative recovery times in pediatric patients undergoing elective laparoscopic surgeries. Read more about this study
- Who is it for?
- Ages 1 month to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Low-flow Anesthesia
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2024to 7 Oct 2024
- 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 1 month to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Pediatric patients undergoing laparoscopic surgery
Who may be able to join
- Patients with an American Society of Anesthesiologists (ASA) classification of I-II.
- Elective laparoscopic surgeries expected to last longer than 30 minutes but shorter than 180 minutes
Who cannot join
- Patients who are not candidates for laparoscopic surgery. Patients unsuitable for low-flow anesthesia due to inadequate monitoring conditions.
- Patients whose relatives are unable to provide informed consent. Patients with an American Society of Anesthesiologists (ASA) classification higher than II.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
19 Mayis Üniversitesi Tip Fakültesi
Samsun, 55200
19 Mayıs Üniversitesi Tıp Fakültesi
Samsun, 55200
About this study
Official title: Evaluation of High and Low Flow Sevoflurane Anesthesia in Pediatric Patients Undergoing Laparoscopic Surgeries in Terms of Recovery, Hemodynamics, and Cost
The primary objective of our study is to compare the effects of different flow rates of the routinely used inhalation agent, sevoflurane, on postoperative recovery times in pediatric patients undergoing elective laparoscopic surgeries. Our secondary objectives are to evaluate the impact of different flow rates on hemodynamic parameters, ventilation parameters, and costs.
Read the detailed description
Low-flow anesthesia is a technique in which at least 50% of the exhaled gas is returned to the system through rebreathing. When using modern rebreathing systems, low-flow anesthesia can be defined if the fresh gas flow rate is reduced below 2 L/min. This anesthesia method involves using an anesthesia system with rebreathing capabilities, where carbon dioxide is removed from the gas mixture exhaled by the patient, and then at least 50% of the fresh oxygen flow, along with volatile anesthetics sufficient to meet the body's metabolic requirements, is returned to the patient.
The application of low-flow anesthesia reduces the consumption of anesthetic gases, decreases the cost of anesthesia, minimizes contamination of the working environment and atmosphere with anesthetic gases, preserves the respiratory physiology of the patient, and minimizes heat and humidity loss by heating and humidifying the gases delivered to the patient, thereby better maintaining the physiology of the trachea and bronchial environments. The heating of gases is also beneficial for maintaining body temperature and preventing postoperative hypothermia. Additionally, due to the requirement for close monitoring, anesthesia safety is increased .
In pediatric patients, due to their different anatomical and physiological characteristics compared to adults, the application of low fresh gas flow anesthesia can be more challenging. This is especially the case when using uncuffed endotracheal tubes, where leaks may occur in the respiratory system, and the breathing circuits used may increase dead space. However, studies have shown that with appropriate techniques and adequate monitoring, these potential problems can be prevented, and low-flow anesthesia can be safely applied in children with close monitoring.
In our study, the investigators aim to compare the effects of different flow rates on postoperative recovery, hemodynamic factors, and costs in children, and to demonstrate that low-flow anesthesia can be applied as safely as high-flow anesthesia in pediatric patients. The investigators believe our study will contribute significantly to the literature on this topic.
- Conditions
- Low-flow Anesthesia
- Keywords
- Laparoscopic surger, Low-flow anesthesia, Pediatric Patient
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 |
|---|---|---|
| Low flow | Low flow Anestesia | |
| High Flow | High Flow Anestesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery times with Aldrete recovery score
Measured: 15/09/24-30/11/24
Secondary outcomes (1)
Incidence of intraoperative hypothermia by esophageal temperature measurements
Measured: 15/09/24-30/11/24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 May 2024
- Primary completion30 Sep 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low-flow AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Barış, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676969
- Sponsor's protocol ID
- High/Low flow Anestesia
- Status last verified
- Jan 2025
- First submitted
- 4 Nov 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Isik Y, Goksu S, Kocoglu H, Oner U. Low flow desflurane and sevoflurane anaesthesia in children. Eur J Anaesthesiol. 2006 Jan;23(1):60-4. doi: 10.1017/S026502150500178X.
PubMed 16390568Park SY, Chung CJ, Jang JH, Bae JY, Choi SR. The safety and efficacy of minimal-flow desflurane anesthesia during prolonged laparoscopic surgery. Korean J Anesthesiol. 2012 Dec;63(6):498-503. doi: 10.4097/kjae.2012.63.6.498. Epub 2012 Dec 14.
PubMed 23277809Glenski TA, Levine L. The implementation of low-flow anesthesia at a tertiary pediatric center: A quality improvement initiative. Paediatr Anaesth. 2020 Oct;30(10):1139-1145. doi: 10.1111/pan.13994. Epub 2020 Aug 29.
PubMed 32786105Meakin GH. Low-flow anaesthesia in infants and children. Br J Anaesth. 1999 Jul;83(1):50-7. doi: 10.1093/bja/83.1.50. No abstract available.
PubMed 10616333
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of High and Low Flow Sevoflurane Anesthesia in Pediatric Patients Undergoing Laparoscopic Surgeries in Terms of Recovery, Hemodynamics, and Cost
- ClinicalTrials.gov ID
- NCT06676969
- Acronym / sponsor ID
- High/Low flow Anestesia
- Conditions
- Low-flow Anesthesia
- Keywords
- Laparoscopic surger, Low-flow anesthesia, Pediatric Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 6 Nov 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.
The primary objective of our study is to compare the effects of different flow rates of the routinely used inhalation agent, sevoflurane, on postoperative recovery times in pediatric patients undergoing elective laparoscopic surgeries. Our secondary objectives are to evaluate the impact of different flow rates on hemodynamic parameters, ventilation parameters, and costs.
Detailed description
Low-flow anesthesia is a technique in which at least 50% of the exhaled gas is returned to the system through rebreathing. When using modern rebreathing systems, low-flow anesthesia can be defined if the fresh gas flow rate is reduced below 2 L/min. This anesthesia method involves using an anesthesia system with rebreathing capabilities, where carbon dioxide is removed from the gas mixture exhaled by the patient, and then at least 50% of the fresh oxygen flow, along with volatile anesthetics sufficient to meet the body's metabolic requirements, is returned to the patient.
The application of low-flow anesthesia reduces the consumption of anesthetic gases, decreases the cost of anesthesia, minimizes contamination of the working environment and atmosphere with anesthetic gases, preserves the respiratory physiology of the patient, and minimizes heat and humidity loss by heating and humidifying the gases delivered to the patient, thereby better maintaining the physiology of the trachea and bronchial environments. The heating of gases is also beneficial for maintaining body temperature and preventing postoperative hypothermia. Additionally, due to the requirement for close monitoring, anesthesia safety is increased .
In pediatric patients, due to their different anatomical and physiological characteristics compared to adults, the application of low fresh gas flow anesthesia can be more challenging. This is especially the case when using uncuffed endotracheal tubes, where leaks may occur in the respiratory system, and the breathing circuits used may increase dead space. However, studies have shown that with appropriate techniques and adequate monitoring, these potential problems can be prevented, and low-flow anesthesia can be safely applied in children with close monitoring.
In our study, the investigators aim to compare the effects of different flow rates on postoperative recovery, hemodynamic factors, and costs in children, and to demonstrate that low-flow anesthesia can be applied as safely as high-flow anesthesia in pediatric patients. The investigators believe our study will contribute significantly to the literature on this topic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low flow | – | –Low flow Anestesia |
| High Flow | – | –High Flow Anestesia |
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Pediatric patients undergoing laparoscopic surgery
Key inclusion criteria (2 listed)
- Patients with an American Society of Anesthesiologists (ASA) classification of I-II.
- Elective laparoscopic surgeries expected to last longer than 30 minutes but shorter than 180 minutes
Key exclusion criteria (2 listed)
- Patients who are not candidates for laparoscopic surgery. Patients unsuitable for low-flow anesthesia due to inadequate monitoring conditions.
- Patients whose relatives are unable to provide informed consent. Patients with an American Society of Anesthesiologists (ASA) classification higher than II.
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
Recovery times with Aldrete recovery score
Time frame: 15/09/24-30/11/24
1 secondary outcome
Incidence of intraoperative hypothermia by esophageal temperature measurements
Time frame: 15/09/24-30/11/24
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 24 Jan 2025.
- Background: PubMed 16390568Isik Y, Goksu S, Kocoglu H, Oner U. Low flow desflurane and sevoflurane anaesthesia in children. Eur J Anaesthesiol. 2006 Jan;23(1):60-4. doi: 10.1017/S026502150500178X.
- Background: PubMed 23277809Park SY, Chung CJ, Jang JH, Bae JY, Choi SR. The safety and efficacy of minimal-flow desflurane anesthesia during prolonged laparoscopic surgery. Korean J Anesthesiol. 2012 Dec;63(6):498-503. doi: 10.4097/kjae.2012.63.6.498. Epub 2012 Dec 14.
- Background: PubMed 32786105Glenski TA, Levine L. The implementation of low-flow anesthesia at a tertiary pediatric center: A quality improvement initiative. Paediatr Anaesth. 2020 Oct;30(10):1139-1145. doi: 10.1111/pan.13994. Epub 2020 Aug 29.
- Background: PubMed 10616333Meakin GH. Low-flow anaesthesia in infants and children. Br J Anaesth. 1999 Jul;83(1):50-7. doi: 10.1093/bja/83.1.50. No abstract available.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low-flow Anesthesia, run by Ondokuz Mayıs University at 2 sites 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 2 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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Recovery times with Aldrete recovery score (time frame: 15/09/24-30/11/24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06676969, which also lists 4 linked publications.
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 24 Jan 2025.