Actively Recruiting

Phase Not Applicable
Age: 2Years - 12Years
All Genders
ID06967675

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

Led by Istinye University · Updated on 2025-07-10

90

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study changes in the perfusion index (PI) in children aged 2 to 12 years undergoing elective surgery with anesthesia. It evaluates how PI relates to stability of blood flow and depth of anesthesia during surgery, and whether using low-flow anesthesia affects the chance of experiencing agitation after waking up. The study involves pediatric patients without major health issues, focusing on anesthesia safety and recovery. Participants will be randomly assigned to one of two groups receiving general anesthesia with different fresh gas flow rates: one group at 1 liter per minute (low-flow anesthesia) and the other at 2 liters per minute (normal-flow anesthesia). Both groups will have their perfusion index and other heart and blood flow measurements monitored at specific times before, during, and after surgery. No extra treatments beyond standard care are applied. During the study, researchers will track perfusion index changes from the start of anesthesia until 30 minutes after the breathing tube is removed. They will also assess the occurrence of emergence agitation after surgery. Parents or guardians will provide consent, and the study will be conducted under close observation to ensure patient safety. The findings aim to help improve anesthesia practices and recovery in children.

CONDITIONS

Brief Title

Perfusion Index in Pediatric Low-Flow Anesthesia

Who Can Participate

Age: 2Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA I-II pediatric patients
  • Age 2 to 12 years
  • Undergoing elective surgery lasting between 1-6 hours
  • Informed consent obtained from parents/guardians
Not Eligible

You will not qualify if you...

  • Cardiovascular, respiratory, neurological, metabolic, or endocrine disorders
  • Premature birth with corrected age less than 2 years
  • Obesity or severe malnutrition (BMI less than 5th or greater than 95th percentile)
  • Psychiatric or neurodevelopmental disorders such as 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 longer than 6 hours duration

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 to 6 hours (duration of surgery and anesthesia)

Participants receive general anesthesia with either low-flow or normal-flow gas flow rates during elective surgery. Perfusion index and hemodynamic parameters are monitored at predetermined time points from anesthesia induction until 30 minutes after extubation.

1 surgery day visit with monitoring until 30 minutes after extubation

Trial Site Locations

Total: 1 location

1

Istinye Üniversity

Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250

Actively Recruiting

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Research Team

I

ilke dolgun

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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Published Research Related To This Trial

Using a pulse oximeter to determine clinical depth of anesthesia-investigation of the utility of the perfusion index.

Anirudh Krishnamohan, Viraj Siriwardana, Justin J Skowno

https://pubmed.ncbi.nlm.nih.gov/27569026

New generation pulse oximetry in the assessment of peripheral perfusion during general anaesthesia - a comparison between propofol and desflurane.

Michał Kowalczyk, Anna Fijałkowska, Andrzej Nestorowicz

https://pubmed.ncbi.nlm.nih.gov/24092509