Perfusion Index in Pediatric Low-Flow Anesthesia

NCT06967675 | Recruiting

• 1 other identifier: haseki low flow
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Perfusion Index; Low-Flow Anesthesia; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• Change in Perfusion Index (PI)

  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.

  From induction to 30 minutes after extubation

Study Arms (2)

Low-Flow Anesthesia Group (LFA)

EXPERIMENTAL

Patients will receive general anesthesia using a fresh gas flow rate of 1 L/min (50% O₂ + 50% air). Perfusion index and hemodynamic parameters will be monitored at predetermined time points.

Procedure: Low-Flow Anesthesia (LFA)

Normal-Flow Anesthesia Group (HFA)

ACTIVE COMPARATOR

Patients will receive general anesthesia using a fresh gas flow rate of 2 L/min (50% O₂ + 50% air). Perfusion index and hemodynamic parameters will be monitored at the same time points.

Procedure: Low-Flow Anesthesia (LFA)

Interventions

Low-Flow Anesthesia (LFA) PROCEDURE

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

Low-Flow Anesthesia Group (LFA); Normal-Flow Anesthesia Group (HFA)

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Krishnamohan A, Siriwardana V, Skowno JJ. Using a pulse oximeter to determine clinical depth of anesthesia-investigation of the utility of the perfusion index. Paediatr Anaesth. 2016 Nov;26(11):1106-1111. doi: 10.1111/pan.13000. Epub 2016 Aug 28.

  PMID: 27569026 RESULT

• RYALINO, CHRISTOPHER, et al. Low-flow anesthesia technique reduces emergence agitation in pediatric patients underwent general anesthesia. Asian Journal of Pharmaceutical and Clinical Research, 2019, 12.5: 139-41.

  RESULT

• Kowalczyk M, Fijalkowska A, Nestorowicz A. New generation pulse oximetry in the assessment of peripheral perfusion during general anaesthesia - a comparison between propofol and desflurane. Anaesthesiol Intensive Ther. 2013 Jul-Sep;45(3):138-44. doi: 10.5603/AIT.2013.0029.

  PMID: 24092509 RESULT

Central Study Contacts

ilke dolgun

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 13, 2025
• Study Start: June 15, 2025
• Primary Completion: August 5, 2025
• Study Completion: August 10, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)