Recruiting

NCT Number: NCT06967675

Perfusion Index in Pediatric Low-Flow Anesthesia

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.

Recruiting

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Key information

Conditions

Perfusion Index Low-flow Anesthesia Postoperative Recovery

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location status: Recruiting

Location contact

ilke dolgun

CONTACT

[email protected]

ilke dolgun

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low-Flow Anesthesia (LFA)

Procedure

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

Primary outcomes

Change in Perfusion Index (PI)

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ilke dolgun

CONTACT

[email protected]

+905555485632

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: May 13, 2025
Registry last updated: Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting