Perfusion Index in Pediatric Low-Flow Anesthesia

Not Applicable

Recruiting

• Conditions: Perfusion Index; Low-Flow Anesthesia; Postoperative Recovery

• Registration Number: NCT06967675
• Lead Sponsor: Istinye University

Brief Summary

This study aims to evaluate changes in perfusion index (PI) in pediatric patients undergoing elective surgery under low-flow anesthesia. PI will be monitored at multiple intraoperative and postoperative time points to assess its relationship with hemodynamic stability and depth of anesthesia. The study will also investigate whether low-flow anesthesia affects the incidence of emergence agitation (EA). Patients will be assigned to either low-flow or normal-flow anesthesia groups based on routine clinical practice. No intervention will be applied beyond standard care. The findings are expected to provide insight into the predictive value of PI in postoperative recovery and support safer anesthesia practices in pediatric populations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-03
• Study First Submitted QC: 2025-05-03
• Study First Posted: 2025-05-13
• Study Start: 2025-06-15
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-08
• Last Update Posted: 2025-07-10
• Primary Completion: 2025-08-05
• Study Completion: 2025-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• ASA I-II pediatric patients
• Age 2 to 12 years
• Undergoing elective surgery lasting between 1-6 hours
• Informed consent obtained from parents/guardians

Exclusion Criteria

• Cardiovascular, respiratory, neurological, metabolic, or endocrine disorders
• Premature birth with corrected age < 2 years
• Obesity or severe malnutrition (BMI <5th or >95th percentile)
• Psychiatric or neurodevelopmental disorders (e.g., autism)
• Malignant hyperthermia or hypersensitivity to anesthetics
• Emergency surgeries
• Lack of IV access requiring inhalational induction
• Contraindications to low-flow anesthesia including:
• Severe pulmonary disease
• Congenital heart disease with shunt physiology
• Anticipated high oxygen demand
• Airway obstruction risk
• Surgeries requiring high gas flow or >6 hours duration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Perfusion Index (PI)	From induction to 30 minutes after extubation	Perfusion Index (PI) will be measured at 11 predefined perioperative time points to assess its intraoperative variation and its potential correlation with anesthesia depth and emergence profile in pediatric patients undergoing low-flow vs normal-flow anesthesia.

Trial Locations

Locations (1)

Istinye Üniversity; 🇹🇷 Istanbul, Merkez Mahallesi, Turkey