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NCT Number: NCT06320743

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

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.

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Key information

Conditions

Child, Only Anesthesia Brain Diseases Central Nervous System Diseases Cerebral Hypoxia Cerebral Oxygenation Hypoxia Hypoxia, Brain Inhalation; Vapor Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Oxygenation Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NIRS ,Ventilation parameters

Device

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

Device

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%

Primary outcomes

  1. Near infrared spectroscopy (NIRS)

    Time frame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

    Cerebral 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 outcomes

  1. Ventilation parameters

    Time frame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

    in the period from intubation to extubation of the patient inspired O2

  2. Ventilation parameters

    Time frame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

    in the period from intubation to extubation of the patient exhaled O2

  3. Ventilation parameters

    Time frame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

    in the period from intubation to extubation of the patient inspire sevoflurane

  4. Ventilation parameters

    Time frame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

    in the period from intubation to extubation of the patient exhaled sevoflurane

  5. Ventilation parameters

    Time frame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

    in the period from intubation to extubation of the patient inspired CO2

  6. Ventilation parameters

    Time frame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

    in the period from intubation to extubation of the patient EtCO2

  7. Ventilation parameters

    Time frame: 0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation

    in the period from intubation to extubation of the patient Minimum Alveolar Concentration (MAK)

  8. İntraoperative sevoflurane consumption

    Time frame: Postoperative 5th minute

    Intraoperative sevoflurane consumption in ml will be noted at the end of the case

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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