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

Ankara City Hospital

Status: Completed

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

Treatments: Device: NIRS ,Ventilation parameters; Device: Oxygen concentration

Study type: Interventional

Funder types: Other

Identifiers

NCT06320743

Low Flow Anaesthesia And NIRS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 2 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Group LFA

Active Comparator group

Description:

NIRS probe will be attached to the inner surface of the forearm and cerebral right-left frontotemporal region and the values will be noted. Standard ASA monitoring and induction will be performed. Fresh gas flow will be 4 lt/min, 50% oxygen/air mixture, sevoflurane vaporizer will be turned on at 4%, continue for 10 minutes and then fresh gas flow will be reduced to 0.8 lt/min, sevoflurane the MAK value will be adjusted to be between 0.9-1.1. 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%. The sevoflurane vaporizer will be turned off 10 minutes before the end of the operation. When the extubation criteria are met, the patient will be extubated.

Treatment:

Device: Oxygen concentration

Device: NIRS ,Ventilation parameters

Group HFA

Active Comparator group

Description:

NIRS probe will be attached to the inner surface of the forearm and cerebral right-left frontotemporal region and the values will be noted. Standard ASA monitoring and induction will be performed.Fresh gas flow will be 3lt/min, 50% oxygen/air mixture, and the sevoflurane vaporizer will be turned on at 3%, sevoflurane the MAK value will be adjusted to be between 0.9-1.1. The sevoflurane vaporizer will be turned off the end of the operation. When the extubation criteria are met, the patient will be extubated.

Treatment:

Device: NIRS ,Ventilation parameters