Minimal- Versus High-Flow Sevoflurane and Emergence Agitation in Pediatric Surgery

NCT07635004 | Active Not Recruiting

• 1 other identifier: E2-24-9001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of minimal-flow sevoflurane compared with high-flow sevoflurane during maintenance of general anesthesia on postoperative emergence agitation in opioid-free pediatric infraumbilical surgeries. Patients will be randomly assigned to receive either opioid-free minimal-flow anesthesia combined with caudal block or opioid-free high-flow anesthesia combined with caudal block. The primary outcome is emergence agitation assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale and the Watcha scale. Secondary outcomes include the incidence of postoperative nausea and vomiting and recovery characteristics. In addition, all patients will be followed up via telephone at 3 months postoperatively to assess the presence of persistent chronic or neuropathic pain at the surgical site. The findings of this study may contribute to optimizing anesthesia strategies and improving postoperative outcomes in pediatric patients.

Conditions

Emergence Agitation; Postoperative Agitation

Keywords

Minimal flow anesthesia; Sevoflurane; Emergence agitation; Pediatric anesthesia

Outcome Measures

Primary Outcomes (1)

• Emergence agitation assessed by Pediatric Anesthesia Emergence Delirium scale

  Pediatric Anesthesia Emergence Delirium (PAED) Scale score ranging from 0 to 20 points. Higher scores indicate more severe emergence delirium. Emergence delirium will be defined as a PAED score ≥10.

  First 30 minutes in PACU

Secondary Outcomes (1)

• Emergence agitation assessed by Watcha scale

  First 30 minutes in the post-anesthesia care unit (PACU)

Study Arms (2)

opioid-free minimal-flow anesthesia

EXPERIMENTAL

In this arm, pediatric patients undergoing infraumbilical surgery under opioid-free general anesthesia receive a caudal epidural block after tracheal intubation. Anesthesia is then maintained with minimal-flow sevoflurane.

Procedure: caudal block

Opioid-Free High-Flow anesthesia

EXPERIMENTAL

Patients receive opioid-free high-flow sevoflurane anesthesia during maintenance of general anesthesia combined with caudal block.

Procedure: caudal block

Interventions

caudal block PROCEDURE

In all patients, a caudal epidural block is performed after induction of general anesthesia and tracheal intubation, prior to the surgical procedure, to provide perioperative analgesia.

Opioid-Free High-Flow anesthesia; opioid-free minimal-flow anesthesia

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aged 2-10 years
• ASA physical status I-II
• Scheduled for elective infraumbilical surgery
• Planned to receive general anesthesia with caudal block
• Written informed consent obtained from parents or legal guardians

You may not qualify if:

• \- Refusal of parental consent
• Known allergy to study drugs
• Neurological or developmental disorders
• Psychiatric disorders or use of psychoactive medications
• Chronic pain or regular analgesic use
• Contraindication to caudal block (infection at site, coagulopathy, anatomical abnormality)
• Significant cardiovascular, respiratory, hepatic, or renal disease
• Emergency surgery
• Signs of failed caudal epidural block, defined as a greater than 20% increase in heart rate or blood pressure in response to surgical stimulation, an increase in bispectral index (BIS) values, or the requirement for additional intravenous anesthetic agents.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (5)

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  PMID: 10360488 BACKGROUND

• Levy JH, Dutton RP, Hemphill JC 3rd, Shander A, Cooper D, Paidas MJ, Kessler CM, Holcomb JB, Lawson JH; Hemostasis Summit Participants. Multidisciplinary approach to the challenge of hemostasis. Anesth Analg. 2010 Feb 1;110(2):354-64. doi: 10.1213/ANE.0b013e3181c84ba5. Epub 2009 Dec 10.

  PMID: 20007735 BACKGROUND

• Enooku K, Kato R, Ikeda H, Kurano M, Kume Y, Yoshida H, Ono T, Aizawa K, Suzuki T, Yamazaki T, Yatomi Y. Inverse correlations between serum ADAMTS13 levels and systolic blood pressure, pulse pressure, and serum C-reactive protein levels observed at a general health examination in a Japanese population: a cross-sectional study. Clin Chim Acta. 2013 Jun 5;421:147-51. doi: 10.1016/j.cca.2013.03.012. Epub 2013 Mar 21.

  PMID: 23523588 BACKGROUND

• Kopterides P, Kapetanakis T, Siempos II, Magkou C, Pelekanou A, Tsaganos T, Giamarellos-Bourboulis E, Roussos C, Armaganidis A. Short-term administration of a high oxygen concentration is not injurious in an ex-vivo rabbit model of ventilator-induced lung injury. Anesth Analg. 2009 Feb;108(2):556-64. doi: 10.1213/ane.0b013e31818f10f7.

  PMID: 19151287 BACKGROUND

• Ryalino C, Senapathi TGD, Pradhana AP, Yudikusumo A. Low-flow anesthesia technique reduces emergence agitation in pediatric patients underwent general anesthesia. Asian J Pharm Clin Res. 2019;12(5):139-141. doi:10.22159/ajpcr.2019.v12i5.32508

  RESULT

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.MD

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: June 9, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): June 22, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)