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Perfusion Index in Pediatric Low-Flow Anesthesia

Changes in Perfusion Index Under Low-Flow Anesthesia and Its Effects on Postoperative Emergence in Pediatric Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06967675
Enrollment
90
Registered
2025-05-13
Start date
2025-06-15
Completion date
2025-08-10
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low-Flow Anesthesia, Perfusion Index, Postoperative Recovery

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.

Interventions

PROCEDURELow-Flow Anesthesia (LFA)

General anesthesia with a fresh gas flow rate of 1 L/min (50% oxygen + 50% air).

Sponsors

Istinye University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

Group allocation is determined by the anesthesia provider during routine care. Both the participant and the outcome assessor are blinded to group assignment. Data analysis is performed without group identifiers.

Intervention model description

ediatric patients undergoing elective surgery will be followed in two naturally assigned groups based on anesthesia flow rate: low-flow (LFA) and normal-flow (HFA). No intervention will be applied outside routine clinical care, and all data will be collected through perioperative monitoring.

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Perfusion Index (PI)From induction to 30 minutes after extubationPerfusion 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.

Countries

Turkey (Türkiye)

Contacts

Primary Contactilke dolgun
ilkeser2004@gmail.com+905555485632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026