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Active Not Recruiting NCT07635004

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

Conditions: Postoperative Agitation, Emergence Agitation

Sex: All
Ages: 2 Years – 10 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 80
Sponsor: Ankara City Hospital Bilkent

Location: Ankara Bilkent City Hospital Ankara

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * \- 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07635004). StuddyBuddy aggregates publicly available trial information.