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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group LFA | Active Comparator | 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. |
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| Group HFA | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Ventilation parameters |
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Inclusion Criteria:
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
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.
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| Name | Affiliation | Role |
|---|---|---|
| Sengül Özmert | Ankara City Hospital Bilkent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital | Ankara | Çankaya | 06800 | Turkey (Türkiye) |
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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.
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| 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% |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| İntraoperative sevoflurane consumption | Intraoperative sevoflurane consumption in ml will be noted at the end of the case | Postoperative 5th minute |
| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| D002534 | Hypoxia, Brain |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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