ıntraoperative Cerebral OxygenationNCT07517146
Comparison of the Effects of Desflurane-Remifentanyl and Propofol-Remifentanyl Anesthesia on Intraoperative Cerebral Oxygenation in Patients Undergoing Laparoscopic Cholecystectomy
An observational study of ıntraoperative Cerebral Oxygenation and Cerebral Oxygenation Monitoring, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ıntraoperative Cerebral Oxygenation, Cerebral Oxygenation Monitoring
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective surgery under general anesthesia, receiving either desflurane - remifentanyl or propofol- remifentanyl anesthesia
Who may be able to join
- Those with ASA 1-2-3
- Those who have undergone laparoscopic cholecystectomy
- Those with BMI between 18-40 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Atatürk Sanatorium Training and Research Hospital
Ankara, Ankara, 06010
Elif Ece Reis, MD, +90 552 716 15 28, eer_933@hotmail.com
About this study
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
Study Population:
Patients undergoing elective laparoscopic cholecystectomy under general anesthesia will be included.
Read more
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
Read the 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.
- Keywords
- NIRS, BIS Monitoring, Laparoscopic Cholecystectomy, desflurane, remifentanil, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative cerebral oxygenation
Intraoperative cerebral oxygenation in patients receiving desflurane-remifentanyl or propofol-remifentanyl anesthesia
Measured: During surgery
Secondary outcomes (10)
Intraoperative SpO2 Values
Intraoperative SpO2 values will be recorded every 20 minutes
Measured: During Surgery (per 20 minutes)
Intraoperative Heart Rate Values
Intraoperative heart rate values will be recorded every 20 minutes
Measured: During surgery (Per 20 minutes)
Intraoperative TV-Tidal Volume Values
Intraoperative TV-Tidal Volume values will be recorded every 20 minutes
Measured: During surgery (Per 20 minutes)
Anesthetic complications
Postoperative anesthetic complications
Measured: From end of surgery until hospital discharge
Correlation between systemic oxygenation and cerebral oxygenation
Correlation of intraoperative cerebral oxygenation with systemic oxygenation parameters
Measured: During surgery (per 20 minutes)
Intraoperative SpO2/FiO2 Values
Intraoperative SpO2/FiO2 values will be recorded every 20 minutes
Measured: During Surgery (per 20 minutes)
Intraoperative Oxygen Saturation Index- OSI Values
The Oxygen Saturation Index- OSI values will be recorded every 20 minutes
Measured: During Surgery (per 20 minutes)
Intraoperative Blood Pressure Values
Intraoperative blood pressure values will be recorded every 20 minutes
Measured: During Surgery ( Per 20 minutes)
Intraoperative PIP- Peak Inspiratory Pressure Values
Intraoperative PIP- Peak Inspiratory Pressure values will be recorded every 20 minutes
Measured: During Surgery ( Per 20 minutes)
Intraoperative Pplat-Plateau Pressure Values
Intraoperative Pplat-Plateau Pressure values will be recorded every 20 minutes
Measured: During Surgery (Per 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start6 Apr 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ıntraoperative Cerebral OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hilal GUNAL SAZAK, Ankara Ataturk Sanatorium Training and Research Hospital
- Investigators
- Hilal Sazak, Prof. Dr, Principal investigator, Ankara Ataturk Sanatorium Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517146
- Sponsor's protocol ID
- CODPCO
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32142512Burchiel 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.
PubMed 38823045Akcay 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.
PubMed 31572991
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07517146
- Acronym / sponsor ID
- CODPCO
- Keywords
- NIRS, BIS Monitoring, Laparoscopic Cholecystectomy, desflurane, remifentanil, propofol
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Ankara Ataturk Sanatorium Training and Research HospitalOther government
- Study start
- 6 Apr 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective surgery under general anesthesia, receiving either desflurane - remifentanyl or propofol- remifentanyl anesthesia
Key inclusion criteria (3 listed)
- Those with ASA 1-2-3
- Those who have undergone laparoscopic cholecystectomy
- Those with BMI between 18-40 kg/m2
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative cerebral oxygenation
Time frame: During surgery
Intraoperative cerebral oxygenation in patients receiving desflurane-remifentanyl or propofol-remifentanyl anesthesia
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 32142512Gurman 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.
- Background: PubMed 38823045Burchiel 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.
- Background: PubMed 31572991Akcay 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hilal Sazak, Prof. Dr principal investigator
Ankara Ataturk Sanatorium Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ıntraoperative Cerebral Oxygenation and Cerebral Oxygenation Monitoring, run by Ankara Ataturk Sanatorium Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ELİF ECE REIS, MD (+90 552 716 15 28, eer_933@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative cerebral oxygenation (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07517146, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.