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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 (SpOâ‚‚), cerebral oxygenation (NIRS), bispectral index (BIS), respiratory mechanics, and derived indices such as the SpOâ‚‚/FiOâ‚‚ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desflurane+Remifentanyl Group | Desflurane+Remifentanyl Group: Patients who receive remifentanil and desflurane during anesthesia | ||
| Propofol + Remifentanyl Group | Propofol + Remifentanyl Group: Patients who receive remifentanyl and propofol during anesthesia |
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| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative cerebral oxygenation | Intraoperative cerebral oxygenation in patients receiving desflurane-remifentanyl or propofol-remifentanyl anesthesia | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative SpO2 Values | Intraoperative SpO2 values will be recorded every 20 minutes | During Surgery (per 20 minutes) |
| Intraoperative Heart Rate Values | Intraoperative heart rate values will be recorded every 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing elective surgery under general anesthesia, receiving either desflurane - remifentanyl or propofol- remifentanyl anesthesia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ELİF ECE REIS, MD | Contact | +90 552 716 15 28 | eer_933@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hilal Sazak, Prof. Dr | Ankara Ataturk Sanatorium Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Atatürk Sanatorium Training and Research Hospital | Ankara | Ankara | 06010 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32142512 | Background | Gurman T, Ballard Sara A, Villanueva Lorenzo F, Luis D, Hunter G, Maloney S, Fujita-Conrads R, Leontsini E. The role of gender in Zika prevention behaviors in the Dominican Republic: Findings and programmatic implications from a qualitative study. PLoS Negl Trop Dis. 2020 Mar 6;14(3):e0007994. doi: 10.1371/journal.pntd.0007994. eCollection 2020 Mar. | |
| 38823045 |
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| During surgery (Per 20 minutes) |
| Intraoperative TV-Tidal Volume Values | Intraoperative TV-Tidal Volume values will be recorded every 20 minutes | During surgery (Per 20 minutes) |
| Anesthetic complications | Postoperative anesthetic complications | From end of surgery until hospital discharge |
| Correlation between systemic oxygenation and cerebral oxygenation | Correlation of intraoperative cerebral oxygenation with systemic oxygenation parameters | During surgery (per 20 minutes) |
| Intraoperative SpO2/FiO2 Values | Intraoperative SpO2/FiO2 values will be recorded every 20 minutes | During Surgery (per 20 minutes) |
| Intraoperative Oxygen Saturation Index- OSI Values | The Oxygen Saturation Index- OSI values will be recorded every 20 minutes | During Surgery (per 20 minutes) |
| Intraoperative Blood Pressure Values | Intraoperative blood pressure values will be recorded every 20 minutes | During Surgery ( Per 20 minutes) |
| Intraoperative PIP- Peak Inspiratory Pressure Values | Intraoperative PIP- Peak Inspiratory Pressure values will be recorded every 20 minutes | During Surgery ( Per 20 minutes) |
| Intraoperative Pplat-Plateau Pressure Values | Intraoperative Pplat-Plateau Pressure values will be recorded every 20 minutes | During Surgery (Per 20 minutes) |
| Burchiel KJ, Ponce F, Lee A, Raslan AM, Ben-Haim S, Sindou M. Introduction. Functional neurosurgery for pain and movement disorders with a special emphasis on spasticity. Neurosurg Focus. 2024 Jun;56(6):E1. doi: 10.3171/2024.3.FOCUS23736. No abstract available. |
| 31572991 | Background | Akcay L, Soyalp C, Yuzkat N, Gulhas N. Comparison of the Effects of Desflurane and Sevoflurane on Cerebral Oxygen Saturation in Patients Undergoing Thyroidectomy: A Randomised Controlled Clinical Study. Turk J Anaesthesiol Reanim. 2019 Oct;47(5):396-401. doi: 10.5152/TJAR.2019.23911. Epub 2019 May 22. |