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Not yet recruiting NCT07401589

Postoperative SpO₂/FiO₂ Ratio and Analgesic Methods in Laparoscopic Surgery

— Observational Postoperative Hypoxemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of Care.
Who it may be relevant to
Registry conditions: Postoperative Hypoxemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Standard of Care
    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.

Primary outcome measures

  • postoperative SpO₂/FiO₂ Ratio [Time frame: Within the first postoperative hour (0-60 minutes after surgery)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Istinye Üniversity — Istanbul

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. PMID 11094011
  • 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. PMID 37645008

Identifiers

NCT: NCT07401589 · 293-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗