Comparison of the Effects of Desflurane-Remifentanyl and Propofol-Remifentanyl Anesthesia on Intraoperative Cerebral Oxygenation in Patients Undergoing Laparoscopic Cholecystectomy

Official title

Comparison of the Effects of Desflurane-Remifentanyl and Propofol-Remifentanyl Anesthesia on Intraoperative Cerebral Oxygenation and Postoperative Complications in Patients Undergoing Laparoscopic Cholecystectomy

Overview

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

Detailed description

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.

Primary outcome measures

• Intraoperative cerebral oxygenation [Time frame: During surgery]

Secondary outcome measures (10)

• Intraoperative SpO2 Values [Time frame: During Surgery (per 20 minutes)]
• Intraoperative Heart Rate Values [Time frame: During surgery (Per 20 minutes)]
• Intraoperative TV-Tidal Volume Values [Time frame: During surgery (Per 20 minutes)]
• Anesthetic complications [Time frame: From end of surgery until hospital discharge]
• Correlation between systemic oxygenation and cerebral oxygenation [Time frame: During surgery (per 20 minutes)]
• Intraoperative SpO2/FiO2 Values [Time frame: During Surgery (per 20 minutes)]
• Intraoperative Oxygen Saturation Index- OSI Values [Time frame: During Surgery (per 20 minutes)]
• Intraoperative Blood Pressure Values [Time frame: During Surgery ( Per 20 minutes)]
• Intraoperative PIP- Peak Inspiratory Pressure Values [Time frame: During Surgery ( Per 20 minutes)]
• Intraoperative Pplat-Plateau Pressure Values [Time frame: During Surgery (Per 20 minutes)]

Eligibility criteria

Inclusion criteria

• Those with ASA 1-2-3
• Those who have undergone laparoscopic cholecystectomy
• Those with BMI between 18-40 kg/m2

Exclusion criteria

• Emergency surgeries
• Individuals with neurological disorders, diseases, or drug (opioid or sedative) use that affect cognitive function
• Individuals who do not speak Turkish
• Individuals who have received general anesthesia within the last 7 days
• Individuals with severe organ dysfunction
• Individuals allergic to the drugs used in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Ankara Atatürk Sanatorium Training and Research Hospital — Ankara

Publications

• 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. PMID 32142512
• 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. PMID 38823045
• 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. PMID 31572991

Identifiers

NCT: NCT07517146 · CODPCO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗