Effect of ORI-guided Oxygen Titration on Oxidative Stress in Rhinoplasty Surgery

NCT07158073 | Completed

• 1 other identifier: DLKCH-AR-RK-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate whether the use of Oxygen Reserve Index (ORİ) can prevent hyperoxia in patients undergoing rhinoplasty surgery and whether it can reduce oxidative stress caused by hyperoxia.

Conditions

Rhinoplasty; Oxidative Stress; Hyperoxia; Oxygen Reserve Index

Keywords

Rhinoplasty surgery; Oxygen Reserve Index; Oxidative Stress; Hyperoxia

Outcome Measures

Primary Outcomes (2)

• Change in thiol-disulfide balance.

  Plasma native thiol, total thiol, and disulfide levels will be measured. The disulfide-to-thiol ratio will be used as a marker of oxidative stress. Unit of Measure: µmol/L

  preoperative to end of surgery (before awakening)

• Change in ischemia-modified albumin (IMA) levels.

  Serum IMA levels will be measured as an indicator of oxidative stress. IMA reflects modification of the N-terminal region of albumin by reactive oxygen species (ROS). Unit of Measure: Absorbance Units (ABS units)

  preoperative-end of surgery (before awakening)

Secondary Outcomes (1)

• PaO₂ levels.

  From baseline (after intubation) to end of surgery (before awakening)

Study Arms (2)

ORI group (Group R)

ACTIVE COMPARATOR

Patients in Group R received ORI monitoring in addition to intraoperative standart monitoring (ECG, pulse oximetry, non-invasive arterial blood pressure). For this purpose, an ORI sensor (RD Rainbow SET sensor, Masimo Corp., Irvine, CA, USA) was placed on the fourth finger of the upper extremity where there was no blood pressure cuff. The sensor was wrapped to prevent exposure to light and connected to an oximeter device (Raical-7® Pulse CO-Oximater®, Masimo Corp., Irvine, CA, USA).In Group R, mask ventilation was administered with 50% oxygen. FiO₂ was titrated between 30% and 50% under the guidance of ORI and SpO₂ values. Accordingly, if SpO₂ was ≥ 98%, FiO₂ was reduced in 5% increments to a minimum of 30%, aiming to achieve an ORI value of 0 or as close to 0 as possible.

Device: FiO₂ titration, under the guidance of ORI

Control group (Group C)

ACTIVE COMPARATOR

Patients in Group C received only standard monitoring. Mask ventilation was administered with 100% oxygen. FiO₂ was maintained at 50% throughout the surgery, provided that SpO₂ remained ≥ 98%.

Device: Conventional oxygen administration

Interventions

FiO₂ titration, under the guidance of ORI DEVICE

In Group R, FiO₂ was titrated between 30% and 50% under the guidance of ORI and SpO₂ values. Accordingly, if SpO₂ was ≥ 98%, FiO₂ was reduced in 5% increments to a minimum of 30%, aiming to achieve an ORI value of 0 or as close to 0 as possible.

ORI group (Group R)

Conventional oxygen administration DEVICE

In Group C, FiO₂ was maintained at 50% throughout the surgery, provided that SpO₂ remained ≥ 98%.

Control group (Group C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• classified as ASA physical status I or II

You may not qualify if:

• under 18 years of age
• ASA classification greater than II
• Mallampati score of 3 or 4
• findings suggestive of difficult intubation during physical examination
• any pathological findings on chest X-ray evaluation (e.g., pleural effusion, nodular density increase, emphysema, atelectasis, calcification, mediastinal widening, or infiltration)
• a history of circulatory disorders
• hematocrit or hemoglobin values outside the normal range (Hemoglobin: 12-16 g/dL for males, 11-14 g/dL for females; Hematocrit: 36-48% for males, 33-42% for females)
• a known hypersensitivity to any anesthetic agent to be used in the study.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, kartal, 34862, Turkey (Türkiye)

Location

Related Publications (1)

• Karakasoglu R, Geyik FD, Cevik BE, Saracoglu KT. The effect of oxygen reserve index guided oxygen titration on oxidative stress in rhinoplasty surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Nov 4;25(1):542. doi: 10.1186/s12871-025-03424-0.

  PMID: 41188744 DERIVED

MeSH Terms

Conditions

Hyperoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Banu E Çevik, MD

  University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital

  STUDY DIRECTOR

• Fatih D Geyik, MD

  University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital

  PRINCIPAL INVESTIGATOR

• Kemal T Saraçoğlu, MD

  University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital

  PRINCIPAL INVESTIGATOR

• Recep karakaşoğlu, MD

  University of Health Sciences, Kartal Dr. Lütfi Kırdar City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the clinicians involved in intraoperative patient management and the researchers responsible for data collection were blinded to group assignments. Additionally, randomization was performed on the day of surgery using the sealed envelope method, whereby patients were randomly assigned to either the ORI group (Group R) or the control group (Group C).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: On the day of surgery, patients were randomly assigned into two groups -ORI group (Group R) and control group (Group C)- using the sealed envelope method. Patients in Group R received ORI monitoring in addition to intraoperative standart monitoring (ECG, pulse oximetry, non-invasive arterial blood pressure). For this purpose, an ORI sensor (RD Rainbow SET sensor, Masimo Corp., Irvine, CA, USA) was placed on the fourth finger of the upper extremity where there was no blood pressure cuff. The sensor was wrapped to prevent exposure to light and connected to an oximeter device (Raical-7® Pulse CO-Oximater®, Masimo Corp., Irvine, CA, USA). Patients in Group C received only standard monitoring.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 5, 2025
• Study Start: March 1, 2021
• Primary Completion: August 20, 2021
• Study Completion: August 30, 2021
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)