- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07401589
Postoperative SpO₂/FiO₂ Ratio and Analgesic Methods in Laparoscopic Surgery
February 3, 2026 updated by: İlke Dolgun, Istinye University
Association of Postoperative SpO₂/FiO₂ Ratio With Body Mass Index, STOP-BANG Score, and Analgesic Methods in Patients Undergoing Laparoscopic Surgery in Reverse Trendelenburg Position
This prospective observational study aims to evaluate the association between postoperative oxygenation, assessed by the SpO₂/FiO₂ ratio, and body mass index (BMI), STOP-BANG score, and postoperative analgesic methods in patients undergoing elective laparoscopic cholecystectomy in the reverse Trendelenburg position.
Postoperative SpO₂ and FiO₂ values will be recorded within the first postoperative hour, and the SpO₂/FiO₂ ratio will be calculated.
Analgesic techniques applied as part of routine clinical practice will be documented.
The study does not involve any additional intervention beyond standard care.
The findings are expected to contribute to a better understanding of factors associated with early postoperative oxygenation and hypoxemia risk.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ilke dolgun
- Phone Number: +905555485632
- Email: ilkeser2004@gmail.com
Study Locations
-
-
Merkez Mahallesi
-
Istanbul, Merkez Mahallesi, Turkey (Türkiye), 34250
- Istinye University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population consists of adult patients aged 18 years and older with ASA physical status I-III who undergo elective laparoscopic cholecystectomy in the reverse Trendelenburg position.
All participants provide written informed consent.
Patients with significant respiratory or cardiovascular comorbidities, emergency surgery, or perioperative respiratory complications are excluded.
Description
Inclusion Criteria:
- Age ≥ 18 years
- Patients who provide written informed consent
- ASA physical status I-III
- Patients undergoing elective laparoscopic cholecystectomy
- Surgery performed in the reverse Trendelenburg position (30°)
- Expected operative duration < 3 hours
- Exclusion Criteria:
- Age < 18 years
- Refusal or inability to provide informed consent
- ASA physical status IV or higher
- Known chronic respiratory diseases (e.g., asthma, COPD)
- Severe cardiac failure (NYHA class III-IV) or advanced cardiovascular disease
- Emergency surgery
- Preoperative oxygen supplementation or baseline SpO₂ < 90%
- Prolonged intubation or perioperative respiratory complications
- Requirement for postoperative noninvasive ventilation or intensive care unit admission
- Missing SpO₂ or FiO₂ data preventing calculation of the SpO₂/FiO₂ ratio
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control
|
No intervention is applied in this study.
Patients are managed according to routine clinical practice.
Demographic data, body mass index, STOP-BANG score, postoperative analgesic methods, and postoperative SpO₂ and FiO₂ values are recorded, and the SpO₂/FiO₂ ratio is calculated.
All data are collected observationally without any additional procedures or changes to standard care.
|
|
Postoperative Observational Cohort
|
No intervention is applied in this study.
Patients are managed according to routine clinical practice.
Demographic data, body mass index, STOP-BANG score, postoperative analgesic methods, and postoperative SpO₂ and FiO₂ values are recorded, and the SpO₂/FiO₂ ratio is calculated.
All data are collected observationally without any additional procedures or changes to standard care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative SpO₂/FiO₂ Ratio
Time Frame: Within the first postoperative hour (0-60 minutes after surgery)
|
The SpO₂/FiO₂ ratio calculated using peripheral oxygen saturation (SpO₂) and fraction of inspired oxygen (FiO₂) measured during the early postoperative period to assess postoperative oxygenation.
|
Within the first postoperative hour (0-60 minutes after surgery)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Perilli V, Sollazzi L, Bozza P, Modesti C, Chierichini A, Tacchino RM, Ranieri R. The effects of the reverse trendelenburg position on respiratory mechanics and blood gases in morbidly obese patients during bariatric surgery. Anesth Analg. 2000 Dec;91(6):1520-5. doi: 10.1097/00000539-200012000-00041.
- Aboseif A, Bedewy A, Nafei M, Hammad R, Amin S. Effect of Intraoperative Lung Recruitment and Transversus Abdominis Plane Block in Laparoscopic Bariatric Surgery on Postoperative Lung Functions: A Randomized Controlled Study. Anesth Pain Med. 2023 Mar 5;13(2):e128440. doi: 10.5812/aapm-128440. eCollection 2023 Apr.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 15, 2026
Primary Completion (Estimated)
March 15, 2026
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
February 3, 2026
First Submitted That Met QC Criteria
February 3, 2026
First Posted (Actual)
February 10, 2026
Study Record Updates
Last Update Posted (Actual)
February 10, 2026
Last Update Submitted That Met QC Criteria
February 3, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 293-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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