NCT06320743

Cerebral and Peripheral Near Infrared Spectroscopy Monitoring in Low and High Flow Anaesthesia in Pediatric

Comparison of the Effects of Low and High Flow Sevoflurane Anesthesia on Cerebral and Peripheral Near Infrared Spectroscopy (NIRS) Values in Pediatric Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Ankara City Hospital Bilkent · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

To investigate the effects of non-invasive cerebral and peripheral NIRS monitoring and low and high flow sevoflurane anaesthesia on cerebral and peripheral NIRS in paediatric patients. To determine the effects of two different flows on these monitoring techniques and thus to facilitate intraoperative patient monitoring and to predict complications (hypoxia) that may occur.

Detailed description

The study will involve American Society of Anesthesiologists Physical Status Classification (ASA) I-III risk group patients, aged between 2 and 12 years, who will under go general anesthesia with a surgical procedure time of 1 hour or more, and who will undergo pediatric surgery, orthopedic and urological surgery, will be included in the study. Preoperative patients' age, gender, height, weight, ASA score and operation type information will be recorded. Patients will be randomized by the sealed envelope method and divided into 2 groups: Low-Flow Anesthesia (LFA) and High-Flow Anesthesia (HFA) groups. Two groups will undergo NIRS monitoring alongside routine ASA monitoring. Cerebral NIRS probe will be attached to the right and left frontotemporal region, and a peripheral NIRS probe will be attached to the inner surface of the forearm and the basal values will be noted.

Conditions

• Child, Only
• Inhalation; Vapor
• Anesthesia
• Cerebral Oxygenation
• Cerebral Hypoxia
• Peripheral Oxygenation

Interventions

Type	Name	Description
DEVICE	NIRS ,Ventilation parameters	NIRS ,Ventilation parameters : Until the patient is taken to the operating table and leaves the operating table routine monitoring parameters, BIS values ,cerebral and peripheral NIRS values, until the patient is intubated and extubated ventilation parameters These parameters; 0. min (before induction), 1. min after induction, pre-post intubation, 5. min, 10. min, 20. min, 30. min, 45. min, 60. min, 90. min after connecting to the ventilator. It will then be noted at 1 hour intervals, and finally at the 5th minute after extubation.
DEVICE	Oxygen concentration	Oxygen concentration : Alarm limits appropriate to the patient's weight will be determined for all patients, the lower limit of inspired O2 will be set as 30%, the upper limit of inspired CO2 will be set as 5mmHg. If the inspired O2 value drops below 30%, the pulse oximeter peripheral SpO2 drops below 97, and the NIRS values drop by 20%, the oxygen concentration will be increased by 10%

Timeline

• Start date: 2024-03-20
• Primary completion: 2024-09-30
• Completion: 2024-11-06
• First posted: 2024-03-20
• Last updated: 2024-12-27

Locations

1 site across 1 country: Turkey (Türkiye)