Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06320743
Enrollment
66
Registered
2024-03-20
Start date
2024-03-20
Completion date
2024-11-06
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Near Infrared Spectroscopy, Low Flow Sevoflurane Anaesthesia, Pediatric, Cerebral and Peripheral Oxygenation

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.

Interventions

DEVICENIRS ,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.

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%

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Near infrared spectroscopy (NIRS)0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubationCerebral and peripheral oxygenation will be measured with a NIRS device at low flow and high flow in pediatric patients whose surgical procedure duration is 60 minute or more and who will undergo pediatric surgery, orthopedic and urological surgery under general anesthesia.

Secondary

MeasureTime frameDescription
Ventilation parameters0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubationin the period from intubation to extubation of the patient inspired O2
İntraoperative sevoflurane consumptionPostoperative 5th minuteIntraoperative sevoflurane consumption in ml will be noted at the end of the case

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026