Low Flow Anesthesia in Children Undergoing Strabismus Surgery

NCT06560268 | Not Yet Recruiting Phase 4

• 1 other identifier: 3/21.03.2024
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Low Flow Anesthesia; Sevoflurane; Strabismus; Emergence Delirium

Keywords

emergence agitation; strabismus; children; low flow anesthesia

Outcome Measures

Primary Outcomes (1)

• Emergence agitation

  Comparison of emergence agitation rates between groups.

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

Secondary Outcomes (1)

• Sevoflurane consumption

  İntraoperative period

Study Arms (3)

High flow anesthesia

EXPERIMENTAL

Group 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.

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 anesthesia

EXPERIMENTAL

Group 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.

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 period

EXPERIMENTAL

Group 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.

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.

Interventions

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.

High flow anesthesia; Low flow anesthesia; Low flow wash-in period

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old children with strabismus

You may not qualify if:

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

Sponsors & Collaborators

• Cukurova University: lead

Related Publications (6)

• 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.

  PMID: 33162569 BACKGROUND

• 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.

  PMID: 22653840 BACKGROUND

• 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.

  PMID: 36814057 BACKGROUND

• 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.

  PMID: 26131225 BACKGROUND

• 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.

  PMID: 16534301 BACKGROUND

• 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.

  PMID: 12760985 RESULT

MeSH Terms

Conditions

Strabismus; Emergence Delirium

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Feride Karacaer, Assoc Prof

  Cukurova University

  STUDY DIRECTOR

Central Study Contacts

Feride Karacaer, Assoc Prof

CONTACT

+90 506 262 8416; feridekaracaer@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: November 4, 2024
• Primary Completion: June 4, 2025
• Study Completion: July 4, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08