An observational study in ıntraoperative Cerebral Oxygenation and Cerebral Oxygenation Monitoring, sponsored by Ankara Ataturk Sanatorium Training and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Ankara Ataturk Sanatorium Training and Research Hospital · Observational
Study Population:
Patients undergoing elective laparoscopic cholecystectomy under general anesthesia will be included.
Study Design:
This is an observational study. No interventions outside routine clinical practice will be applied. All procedures will be performed by experienced anesthesiologists according to standard institutional protocols.
Data Collection
Preoperative Data:
The following variables will be recorded from anesthesia charts:
Demographics: age, sex, height, weight, body mass index (BMI) Education level Smoking, alcohol, and substance use status Routine preoperative laboratory tests
Clinical scores:
Charlson Comorbidity Index (CCI) Beck Anxiety Scale ARISCAT Score STOP-BANG Score Montreal Cognitive Assessment (MoCA) ASA Physical Status Classification
Intraoperative Data:
Patients will be observed in two groups based on anesthesia technique:
Desflurane + remifentanyl Total intravenous anesthesia (TIVA: propofol + remifentanyl)
The following parameters will be recorded:
Hemodynamic data: blood pressure, heart rate Oxygenation parameters: SpO₂, SpO₂/FiO₂ ratio Cerebral and depth monitoring: NIRS, BIS Respiratory mechanics Oxygen Saturation Index (OSI = [Pmean × FiO₂] / SpO₂) Mechanical ventilator parameters
Time Points for Measurement:
Before induction After induction After intubation Every 20 minutes intraoperatively After extubation
Additional Intraoperative Variables:
Duration of surgery and anesthesia
Total anesthetic drug consumption:
Desflurane and remifentanyl Propofol and remifentanyl (TIVA group) Intraoperative blood transfusion (yes/no) Total blood loss Urine output Recovery time Postoperative Follow-up ICU admission (planned or unplanned)
Pain assessment using Numeric Rating Scale (NRS):
PACU Postoperative 1st, 3rd, 6th, 12th, and 24th hours
Postoperative Complications:
Nausea and vomiting Hypotension Arrhythmia (bradycardia, tachycardia) Pulmonary edema Atelectasis Pneumonia Pneumothorax Pleural effusion Cognitive dysfunction
Other Outcomes:
Postoperative MoCA and Beck Anxiety Scale scores Length of hospital stay Length of ICU stay (if applicable) Mortality during follow-up
This observational study aims to investigate the relationship between intraoperative cerebral oxygenation and systemic oxygenation parameters in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Cerebral oxygenation monitoring using near-infrared spectroscopy (NIRS) has become increasingly important in perioperative care, as it provides real-time, non-invasive information about cerebral perfusion and oxygen balance. However, the relationship between cerebral oxygenation and routinely monitored systemic oxygenation parameters remains unclear. This study is designed to evaluate these associations under standardized clinical conditions.
After obtaining ethics committee approval, patients scheduled for elective laparoscopic cholecystectomy will be prospectively enrolled. All procedures will be conducted according to routine clinical practice without any additional intervention. Anesthesia management will be performed by experienced anesthesiologists following institutional protocols.
Patients will be observed according to the anesthesia technique applied: desflurane-remifentanyl anesthesia or total intravenous anesthesia (TIVA) with propofol-remifentanyl. Intraoperative monitoring will include standard hemodynamic parameters, peripheral oxygen saturation (SpO₂), cerebral oxygenation (NIRS), bispectral index (BIS), respiratory mechanics, and derived indices such as the SpO₂/FiO₂ ratio and oxygen saturation index (OSI).
Measurements will be recorded at predefined time points, including before and after induction, after intubation, after positioning, at 20-minute intervals during surgery, and after extubation. Additional intraoperative data such as anesthetic drug consumption, duration of surgery and anesthesia, blood loss, transfusion requirements, urine output, and recovery time will also be documented.
Postoperative outcomes will include pain scores assessed by the Numeric Rating Scale (NRS) at multiple time points, intensive care unit (ICU) admission, and postoperative complications such as nausea, vomiting, hemodynamic instability, respiratory complications, and cognitive dysfunction. Cognitive and anxiety assessments will be performed using the Montreal Cognitive Assessment (MoCA) and Beck Anxiety Scale. Length of hospital stay, ICU stay, and mortality will also be recorded.
The findings of this study are expected to contribute to a better understanding of the relationship between cerebral and systemic oxygenation and may help optimize intraoperative monitoring strategies in routine anesthesia practice.
Adult patients undergoing elective surgery under general anesthesia, receiving either desflurane - remifentanyl or propofol- remifentanyl anesthesia
Exclusion Criteria:
Desflurane+Remifentanyl Group: Patients who receive remifentanil and desflurane during anesthesia
Propofol + Remifentanyl Group: Patients who receive remifentanyl and propofol during anesthesia
Intraoperative cerebral oxygenation
Intraoperative cerebral oxygenation in patients receiving desflurane-remifentanyl or propofol-remifentanyl anesthesia
Time frame: During surgery
Intraoperative SpO2 Values
Intraoperative SpO2 values will be recorded every 20 minutes
Time frame: During Surgery (per 20 minutes)
Intraoperative Heart Rate Values
Intraoperative heart rate values will be recorded every 20 minutes
Time frame: During surgery (Per 20 minutes)
Intraoperative TV-Tidal Volume Values
Intraoperative TV-Tidal Volume values will be recorded every 20 minutes
Time frame: During surgery (Per 20 minutes)
Anesthetic complications
Postoperative anesthetic complications
Time frame: From end of surgery until hospital discharge
Correlation between systemic oxygenation and cerebral oxygenation
Correlation of intraoperative cerebral oxygenation with systemic oxygenation parameters
Time frame: During surgery (per 20 minutes)
Intraoperative SpO2/FiO2 Values
Intraoperative SpO2/FiO2 values will be recorded every 20 minutes
Time frame: During Surgery (per 20 minutes)
Intraoperative Oxygen Saturation Index- OSI Values
The Oxygen Saturation Index- OSI values will be recorded every 20 minutes
Time frame: During Surgery (per 20 minutes)
Intraoperative Blood Pressure Values
Intraoperative blood pressure values will be recorded every 20 minutes
Time frame: During Surgery ( Per 20 minutes)
Intraoperative PIP- Peak Inspiratory Pressure Values
Intraoperative PIP- Peak Inspiratory Pressure values will be recorded every 20 minutes
Time frame: During Surgery ( Per 20 minutes)
Intraoperative Pplat-Plateau Pressure Values
Intraoperative Pplat-Plateau Pressure values will be recorded every 20 minutes
Time frame: During Surgery (Per 20 minutes)
Plan to share: No
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Ankara Ataturk Sanatorium Training and Research Hospital