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

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

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.

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.

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

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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