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

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06320743
• Other study ID #: Low Flow Anaesthesia And NIRS
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: September 19, 2024

Study information

• Verified date: March 2024
• Source: Ankara City Hospital Bilkent
• Contact: Rabia Bayar
• Phone: 5393300403
• Email: rabiabtlbayar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: September 19, 2024
• Est. primary completion date: August 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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%

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near infrared spectroscopy (NIRS)	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.	0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
Secondary	Ventilation parameters	in the period from intubation to extubation of the patient inspired O2	0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
Secondary	Ventilation parameters	in the period from intubation to extubation of the patient exhaled O2	0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
Secondary	Ventilation parameters	in the period from intubation to extubation of the patient inspire sevoflurane	0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
Secondary	Ventilation parameters	in the period from intubation to extubation of the patient exhaled sevoflurane	0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
Secondary	Ventilation parameters	in the period from intubation to extubation of the patient inspired CO2	0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
Secondary	Ventilation parameters	in the period from intubation to extubation of the patient EtCO2	0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
Secondary	Ventilation parameters	in the period from intubation to extubation of the patient Minimum Alveolar Concentration (MAK)	0., 1., 5., 10., 20., 30., 45., 60., 90.,120.min and every 60 minutes thereafter, finally at the 5th minute after extubation
Secondary	Intraoperative sevoflurane consumption	Intraoperative sevoflurane consumption in ml will be noted at the end of the case	Postoperative 5th minute