Clinical trial NCT06967675: Perfusion Index in Pediatric Low-Flow Anesthesia
Official title: Changes in Perfusion Index Under Low-Flow Anesthesia and Its Effects on Postoperative Emergence in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perfusion Index
Low-Flow Anesthesia
Postoperative Recovery
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Perfusion Index (PI)
timeFrame: From induction to 30 minutes after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye Üniversity
state: Merkez Mahallesi
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.