Comparison of the Effects of Desflurane-Remifentanyl and Propofol-Remifentanyl Anesthesia on Intraoperative Cerebral Oxygenation and Postoperative Complications in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Intraoperative cerebral oxygenation
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those with ASA 1-2-3
- •Those who have undergone laparoscopic cholecystectomy
- •Those with BMI between 18-40 kg/m2
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Intraoperative cerebral oxygenation
时间窗: During surgery
Intraoperative cerebral oxygenation in patients receiving desflurane-remifentanyl or propofol-remifentanyl anesthesia
次要结局
- Intraoperative SpO2 Values(During Surgery (per 20 minutes))
- Intraoperative Heart Rate Values(During surgery (Per 20 minutes))
- Intraoperative TV-Tidal Volume Values(During surgery (Per 20 minutes))
- Anesthetic complications(From end of surgery until hospital discharge)
- Correlation between systemic oxygenation and cerebral oxygenation(During surgery (per 20 minutes))
- Intraoperative SpO2/FiO2 Values(During Surgery (per 20 minutes))
- Intraoperative Oxygen Saturation Index- OSI Values(During Surgery (per 20 minutes))
- Intraoperative Blood Pressure Values(During Surgery ( Per 20 minutes))
- Intraoperative PIP- Peak Inspiratory Pressure Values(During Surgery ( Per 20 minutes))
- Intraoperative Pplat-Plateau Pressure Values(During Surgery (Per 20 minutes))
研究者
Hilal GUNAL SAZAK
Professor of Anesthesiology
Ankara Ataturk Sanatorium Training and Research Hospital