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Low Flow AnesthesiaPhase 4LFA in childNCT06560268

Low Flow Anesthesia in Children Undergoing Strabismus Surgery

A Phase 4 study testing Sevoflurane; In our study, the effects of sevoflurane in different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated. in people with Low Flow Anesthesia and Sevoflurane, run by Cukurova University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Emergence agitation (EA) involves restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anesthesia. Sevoflurane and desflurane have increased the incidence of EA in children. Read more about this study

Who is it for?
Ages 3 to 10 years
Conditions the study is for
Low Flow Anesthesia, Sevoflurane, Strabismus
What is being tested?
Sevoflurane; In our study, the effects of sevoflurane in different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
No sites listed yet
Study dates
4 Nov 2024to 4 Jul 2025
Phase
Phase 4
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 3 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 3-10 years old children with strabismus

Who cannot join

  • Mental retardation
  • Cardiovascular disease
  • Serebrovasculay disease
  • Renal disease
  • Hepatic disease
  • Pulmonary disease

Trial locations and contacts

No sites are listed yet.

Feride Karacaer, Assoc Prof contact

+90 506 262 8416

feridekaracaer@gmail.com

About this study

Official title: Effects of Different Fresh Gas Flows on Emergence Agitation and Anesthetic Agent Consumption in Children Undergoing Strabismus Surgery

Emergence agitation (EA) involves restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anesthesia. Sevoflurane and desflurane have increased the incidence of EA in children. A proposed explanation for this is that sevoflurane and desflurane cause differential recovery rates in brain function, due to differences in clearance of inhalational anesthetics from the central nervous system; whereas audition and locomotion recover first, cognitive function recovers later, resulting in EA. Low-flow anaesthesia (LFA) occurs when the fresh gas flow (FGF) is significantly lower than the patient's minute volume. In a low-flow system, the recirculated fraction should amount to at least 50% after carbon dioxide (CO2) absorption.In LFA using minimal FGF (250-500 mL/min), if the vaporizer is turned off 10-15 minutes before the end of the operation and the FGF is not changed, the inhaled anesthetic agent concentration gradually and slowly decreases to zero and the inhaled agent consumption decreases even more. In a study conducted on infants undergoing cleft lip-palate surgery, it was shown that the incidence of postoperative agitation were statistically lower in infants who administered 0.5 L/min FGF.

Strabismus surgery is one of the most frequently performed ophthalmologic operations in children and is associated with moderate postoperative pain and a high incidence of EA (40-86%). The incidence of EA after strabismus surgery is high, especially due to visual disturbances; however, the pathogenesis of this condition remains unclear. In our study, the effects of different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.

Read the detailed description

Emergence agitation (EA) involves restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anesthesia. The incidence of EA varies, from approximately 0.25% to 90.5%, with age, assessment tool used, definitions, anesthetic techniques, type of surgery, and time of EA assessment during recovery. The clinical consequences of EA are similarly varied. It is typically short lived and resolves spontaneously, and its clinical consequences are often considered minimal. However, it may have clinically significant consequences, such as injury to the affected patient or their medical staff, falling out of bed, bleeding at the surgical site, accidental removal of drains or intravenous catheters, unintended extubation, respiratory depression, and increasing medical care costs.

Sevoflurane and desflurane have increased the incidence of EA in children. A proposed explanation for this is that sevoflurane and desflurane cause differential recovery rates in brain function, due to differences in clearance of inhalational anesthetics from the central nervous system; whereas audition and locomotion recover first, cognitive function recovers later, resulting in EA. In addition, studies on pediatric patients have found that being awakened rapidly by unfamiliar healthcare personnel in an unfamiliar operating room environment is a potential risk factor for EA. Rapid clearance of anesthetic agents from subcortical structures (locus coeruleus and amygdala) before the cerebral cortex and rapid recovery have been suggested as a causal factor for EA. Therefore, methods to reduce the incidence of EA aim to reduce the concentration difference between cortical and subcortical areas by slowing down the elimination of inhaled anesthetic agents.

Low-flow anaesthesia (LFA) occurs when the fresh gas flow (FGF) is significantly lower than the patient's minute volume. In a low-flow system, the recirculated fraction should amount to at least 50% after carbon dioxide (CO2) absorption. There are various techniques for the introduction of the inhaled anesthetic. In general, they all follow the same sequence: nitrogen wash-out, a period of higher flow rate in combination with a high vaporizer setting for initial saturation, and subsequent reduction of fresh gas flow and adjustment of the vaporizer to maintain the desired end-tidal anesthetic agent concentration (Etaa). The wash-in period (saturation of the central nervous system area where the inhaled agent is effective) depends on the initial FGF and the vaporizer setting. In the initial wash-in phase, the vaporizer setting is adjusted to 6% for desflurane and 2.5-3% for sevoflurane, with FGF = 4 L/min, until the Etaa concentration is 1-1.3 MAC. In another method, the vaporizer setting is adjusted to 12-18% for desflurane and 6-8% for sevoflurane, with FGF = 1 L/min. Reducing the FGF during the wash-in period prevents unnecessary depth of anesthesia and reduces the consumption of inhalational anesthetics. The wash-in, i.e., the saturation of the gaseous compartment, is dependent on the initial fresh gas flow and the vaporizer setting. Reducing FGF from 4 to 1 L/min reduces inhalation anesthetic consumption by 45.3% (desflurane) and 51.8% (sevoflurane), respectively. In parallel, there is a significant reduction in CO2e emissions and anesthesia costs per minute of approximately 45-50%. When the Etaa concentration is 1-1.3 MAC, the maintenance period is started with a FGF between 0.25-1 L/min. In LFA using minimal FGF (250-500 mL/min), if the vaporizer is turned off 10-15 minutes before the end of the operation and the FGF is not changed, the inhaled anesthetic agent concentration gradually and slowly decreases to zero and the inhaled agent consumption decreases even more (4-5). In a study conducted on infants undergoing cleft lip-palate surgery, it was shown that the incidence of postoperative agitation were statistically lower in infants who administered 0.5 L/min FGF.

Strabismus surgery is one of the most frequently performed ophthalmologic operations in children and is associated with moderate postoperative pain and a high incidence of EA (40-86%). The incidence of EA after strabismus surgery is high, especially due to visual disturbances; however, the pathogenesis of this condition remains unclear. In our study, the effects of different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.

METHOD 150 patients aged 3-10 years undergoing strabismus surgery will be included in the study. Patients will be randomly divided into three groups. Using a 4-point scale, preoperative agitation will be evaluated in the reception area and then, 0.05 mg/kg intravenous (iv) midazolam will be administered for premedication.

For anesthesia induction, all patients will be administered 3 mg/kg propofol and 0.5 mg/kg rocuronium and mechanical ventilation will be performed with a laryngeal mask. A tidal volume of 6-8 ml/kg will be applied and end-tidal CO2 will be maintained between 30-35 mmHg. After induction, all children will be administered 1 μg/kg fentanyl IV. In all patients, the sevoflurane concentration (in the O2 and air mixture) will be titrated between MAC= 1-1.3 throughout the operation, keeping BIS= 40-60 and baseline hemodynamic changes between ±20%. The inspiratory oxygen concentration (FiO2) alarm lower limit will be set to 30% in all patients.

Patients will be randomly divided into 3 groups:

Group I; After the laryngeal mask is placed, ventilation will be performed with FGF= 4 l/min, vaporizer setting will be 2.5-3%. When the patients reach 1 MAC, FGF will be reduced to 2 l/min.

Group II; After the laryngeal mask is placed, ventilation will be performed with FGF= 4 l/min, vaporizer setting will be 2.5-3% and when the patients reach 1 MAC, FGF= 0.5 l/min will be reduced.

Group III; After the laryngeal mask is placed, ventilation will be performed with FGF= 1 l/min, vaporizer setting will be 8%, inhaled sevoflurane concentration (Fisevo) will be gradually reduced to <4%. When the children reach 1 MAC, FGF= 0.5 l/min will be reduced.

In Group I, the vaporizer will be turned off at the end of the operation and FGF will be increased to 10 l/min.

In Group II and III, the vaporizer will be turned off 10 minutes before the end of the operation and FGF will continue as 0.5 l/min until the end of the operation.

All patients will be assessed by an anesthesiologist, who is unaware of the study protocol, at postoperative 5, 10, 15, 30 and 45. minutes and at 2 hours using the 5-point Emergence Agitation Scale and the Pediatric Anesthesia Emergence Delirium (PAED) in the postoperative recovery unit. Postoperative pain will be assessed using the Children\&#39;s Hospital of Eastern Ontario Pain Scale (CHEOPS). If the patient\&#39;s PAED score is ≥16, iv fentanyl (1 μg/kg) will be administered. Postoperative adverse events including laryngospasm, desaturation (SpO2<95%), nausea and vomiting will also be recorded. In the recovery unit, children with a modified Aldrete anesthesia discharge score \&gt;9 will be transferred to the ward.

Being tested
Sevoflurane; In our study, the effects of sevoflurane in different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.
Keywords
emergence agitation, strabismus, children, low flow anesthesia
Medical subject headings
Strabismus, Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sevoflurane; In our study, the effects of sevoflurane in different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.Drug

    Low-flow anaesthesia is generally adminstered as nitrogen wash-out, a period of higher flow rate in combination with a high vaporizer setting for initial saturation, and subsequent reduction of fresh gas flow and adjustment of the vaporizer to maintain the desired end-tidal anesthetic agent concentration (Etaa).In the initial wash-in phase, the vaporizer setting is adjusted to 6% for desflurane and 2.5-3% for sevoflurane, with FGF=4 L/min, until the Etaa concentration is 1-1.3 MAC. In another method, the vaporizer setting is adjusted to 12-18% for desflurane and 6-8% for sevoflurane, with FGA=1 L/min. Reducing the FGF during the wash-in period prevents unnecessary depth of anesthesia and reduces the consumption of inhalational anesthetics. In LFA using minimal FGF (250-500 mL/min), if the vaporizer is turned off 10-15 min before the end of the operation and the FGF is not changed, the inhaled anesthetic agent concentration gradually and slowly decreases to zero.

Study groups in NCT06560268
Study groupRoleWhat they receive
High flow anesthesiaExperimentalGroup I; After the laryngeal mask is placed, ventilation will be performed with FGF= 4 l/min, Sevoflurane vaporizer setting will be 2.5-3%. When the patients reach 1 MAC Sevoflurane, FGF will be reduced to 2 l/min. In Group I, the Sevoflurane vaporizer will be turned off at the end of the operation and FGF will be increased to 10 l/min.
Receives: Drug: Sevoflurane; In our study, the effects of sevoflurane in different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.
Low flow anesthesiaExperimentalGroup II; After the laryngeal mask is placed, ventilation will be performed with FGF= 4 l/min, Sevoflurane vaporizer setting will be 2.5-3% and when the patients reach 1 MAC, FGF= 0.5 l/min will be reduced. In Group II, the Sevoflurane vaporizer will be turned off 10 minutes before the end of the operation and FGF will continue as 0.5 l/min until the end of the operation.
Receives: Drug: Sevoflurane; In our study, the effects of sevoflurane in different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.
Low flow wash-in periodExperimentalGroup III; After the laryngeal mask is placed, ventilation will be performed with FGF= 1 l/min, Sevoflurane vaporizer setting will be 8%, inhaled sevoflurane concentration (Fisevo) will be gradually reduced to < 4%. When the children reach 1 MAC sevoflurane, TGA= 0.5 l/min will be reduced. In Group III, the sevoflurane vaporizer will be turned off 10 minutes before the end of the operation and FGF will continue as 0.5 l/min until the end of the operation.
Receives: Drug: Sevoflurane; In our study, the effects of sevoflurane in different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emergence agitation

    Comparison of emergence agitation rates between groups.

    Measured: At postoperative 5th, 10th, 15th, 30th, 45th min and 2 hour

Secondary outcomes (1)
  1. Sevoflurane consumption

    Effects of different fresh gas flows on sevoflurane consumption

    Measured: İntraoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start4 Nov 2024 (estimated)
  3. Primary completion4 Jun 2025 (estimated)
  4. Study completion4 Jul 2025 (estimated)

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06560268
Sponsor's protocol ID
3/21.03.2024
Acronym
LFA in child
Status last verified
Aug 2024
First submitted
15 Aug 2024
Last updated
26 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sripriya R, Ravindran C, Murugesan R. Comparison of recovery characteristics with two different washout techniques of desflurane anaesthesia: A randomised controlled trial. Indian J Anaesth. 2020 Sep;64(9):756-761. doi: 10.4103/ija.IJA_623_20. Epub 2020 Sep 1.

    PubMed 33162569
  • Brattwall M, Warren-Stomberg M, Hesselvik F, Jakobsson J. Brief review: theory and practice of minimal fresh gas flow anesthesia. Can J Anaesth. 2012 Aug;59(8):785-97. doi: 10.1007/s12630-012-9736-2. Epub 2012 Jun 1.

    PubMed 22653840
  • Rubsam ML, Kruse P, Dietzler Y, Kropf M, Bette B, Zarbock A, Kim SC, Honemann C. A call for immediate climate action in anesthesiology: routine use of minimal or metabolic fresh gas flow reduces our ecological footprint. Can J Anaesth. 2023 Mar;70(3):301-312. doi: 10.1007/s12630-022-02393-z. Epub 2023 Feb 22.

    PubMed 36814057
  • Yang Y, Song T, Wang H, Gu K, Ma P, Ma X, Zhao J, Li Y, Zhao J, Yang G, Yan R. Comparison of two different sevoflurane expelling methods on emergence agitation in infants following sevoflurane anesthesia. Int J Clin Exp Med. 2015 Apr 15;8(4):6200-5. eCollection 2015.

    PubMed 26131225
  • Aouad MT, Nasr VG. Emergence agitation in children: an update. Curr Opin Anaesthesiol. 2005 Dec;18(6):614-9. doi: 10.1097/01.aco.0000188420.84763.35.

    PubMed 16534301
  • Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.

    PubMed 12760985

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sevoflurane; In our study, the effects of sevoflurane in different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated. in people with Low Flow Anesthesia and Sevoflurane, run by Cukurova University.

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 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Feride Karacaer, Assoc Prof (+90 506 262 8416, feridekaracaer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emergence agitation (time frame: At postoperative 5th, 10th, 15th, 30th, 45th min and 2 hour). 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 NCT06560268, which also lists 6 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 26 Aug 2024.

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