Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07517146

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intraoperative cerebral oxygenation

    Time frame: During surgery

    Intraoperative cerebral oxygenation in patients receiving desflurane-remifentanyl or propofol-remifentanyl anesthesia

Secondary outcomes

  1. Intraoperative SpO2 Values

    Time frame: During Surgery (per 20 minutes)

    Intraoperative SpO2 values will be recorded every 20 minutes

  2. Intraoperative Heart Rate Values

    Time frame: During surgery (Per 20 minutes)

    Intraoperative heart rate values will be recorded every 20 minutes

  3. Intraoperative TV-Tidal Volume Values

    Time frame: During surgery (Per 20 minutes)

    Intraoperative TV-Tidal Volume values will be recorded every 20 minutes

  4. Anesthetic complications

    Time frame: From end of surgery until hospital discharge

    Postoperative anesthetic complications

  5. Correlation between systemic oxygenation and cerebral oxygenation

    Time frame: During surgery (per 20 minutes)

    Correlation of intraoperative cerebral oxygenation with systemic oxygenation parameters

  6. Intraoperative SpO2/FiO2 Values

    Time frame: During Surgery (per 20 minutes)

    Intraoperative SpO2/FiO2 values will be recorded every 20 minutes

  7. Intraoperative Oxygen Saturation Index- OSI Values

    Time frame: During Surgery (per 20 minutes)

    The Oxygen Saturation Index- OSI values will be recorded every 20 minutes

  8. Intraoperative Blood Pressure Values

    Time frame: During Surgery ( Per 20 minutes)

    Intraoperative blood pressure values will be recorded every 20 minutes

  9. Intraoperative PIP- Peak Inspiratory Pressure Values

    Time frame: During Surgery ( Per 20 minutes)

    Intraoperative PIP- Peak Inspiratory Pressure values will be recorded every 20 minutes

  10. Intraoperative Pplat-Plateau Pressure Values

    Time frame: During Surgery (Per 20 minutes)

    Intraoperative Pplat-Plateau Pressure values will be recorded every 20 minutes

Study contacts

Contact information is provided by the study sponsor or research team.

ELİF ECE REIS, MD

CONTACT

[email protected]

+90 552 716 15 28

Sponsors and collaborators

Lead sponsor

Ankara Ataturk Sanatorium Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.