Clinical trial NCT06320743: Cerebral and Peripheral Near Infrared Spectroscopy Monitoring in Low and High Flow Anaesthesia in Pediatric
Official title: Comparison of the Effects of Low and High Flow Sevoflurane Anesthesia on Cerebral and Peripheral Near Infrared Spectroscopy (NIRS) Values in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Inhalation; Vapor
Anesthesia
Cerebral Oxygenation
Cerebral Hypoxia
Peripheral Oxygenation
Keywords: Near Infrared Spectroscopy
Low Flow Sevoflurane Anaesthesia
Pediatric
Cerebral and Peripheral Oxygenation
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 values will be noted.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Between 2-12 years of age, those who are planned to undergo pediatric surgery, orthopedic and urological surgery, and whose procedure time is 1 hour or more
* ASA I-III risk group
* Patients who agreed to be included in the study
* Patients whose informed consent form is approved by their parents will be included in the study.

Exclusion Criteria:

* Patients who do not want to participate in the study
* Patients with ASA score above III
* ASA III patients with decompensated cardiac and pulmonary disease
* Patients with neurological sequelae
* Cases with an operation duration of less than 1 hour
* Patients with contraindications to the use of any anesthetic drugs
* Patients for whom low-flow anesthesia is contraindicated

  * Smoke and gas poisoning
  * Malignant Hyperthermia
  * Septic Shock
  * CO2 absorbent depletion
  * Insufficient oxygen monitoring
* Laparoscopic surgeries
* Patients who develop unexpected intra-operative surgical complications
* Patients whose parents do not approve the informed consent form will not be included in the study.

Primary outcomes:
measure: Near infrared spectroscopy (NIRS)
timeFrame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
Secondary outcomes:
measure: Ventilation parameters
timeFrame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
measure: Ventilation parameters
timeFrame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
measure: Ventilation parameters
timeFrame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
measure: Ventilation parameters
timeFrame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
measure: Ventilation parameters
timeFrame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
measure: Ventilation parameters
timeFrame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
measure: Ventilation parameters
timeFrame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
measure: İntraoperative sevoflurane consumption
timeFrame: Postoperative 5th minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Sengül Özmert
role: PRINCIPAL_INVESTIGATOR
References: