Effect of Perioperative IV Ibuprofen on Cerebral Oxygenation and Postoperative Cognition During One-Lung Ventilation

NCT07399184 | Not Yet Recruiting

• 1 other identifier: IBU2025
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study compares the effects of ibuprofen administered during surgery and within the first 24 hours after surgery, versus no ibuprofen, on cerebral oxygenation, postoperative changes in consciousness (postoperative delirium and cognitive dysfunction), length of stay in the intensive care unit, and the incidence of postoperative pain, nausea, vomiting, and pruritus in patients undergoing lung lobectomy or segmentectomy using a closed (video-assisted) method (VATS - video-assisted thoracoscopic surgery), in whom one-lung ventilation is applied. The aim of this study is to evaluate the effects of ibuprofen on cerebral oxygenation, postoperative cognitive changes, and delirium in patients undergoing one-lung ventilation.

Conditions

Postoperative Delirium; Cerebral Oxygen Saturation; Postoperative Cognitive Dysfunction (POCD)

Keywords

cerebral oxygenation; near infrared spectroscopy; thoracic anesthesia; postoperative delirium; one lung ventilation; ibuprofen

Outcome Measures

Primary Outcomes (1)

• Right and left intraoperative cerebral oxygenation values (rScO₂)

  The primary outcome of this study is the preoperative and intraoperative right and left regional cerebral oxygenation values. Cerebral oxygenation is measured using near-infrared spectroscopy (NIRS). The ability of near-infrared light to penetrate biological tissues and to be absorbed by oxyhemoglobin and deoxyhemoglobin constitutes the basic principle of regional cerebral oxygen saturation measurement. Using this method, the balance between oxygen supply and demand in cerebral tissue can be continuously evaluated in real time. During measurements, it is assumed that the blood volume within the venous, capillary, and arterial compartments of the brain remains constant. Therefore, cerebral oximeters provide an average value reflecting the oxygenation of these compartments. Low regional cerebral oxygen saturation values have been associated with cerebral hypoxia and/or ischemia.

  preoperative and intraoperative

Secondary Outcomes (4)

• Postoperative cognitive dysfunction (MMSE score)

  until the end of postoperative day 2 and preoperative day

• Postoperative delirium score (NU-DESC)

  until the end of postoperative day 2

• Postoperative Resting and activity NRS score (Numeric Rating Scale)

  until the end of postoperative day 1

• Postoperative nausea and vomiting status

  until the end of postoperative day 1

Study Arms (2)

IBUPROFEN (GROUP B)

EXPERIMENTAL

In the study, patients will be randomized into two groups (Group B: ibuprofen group; Group C: control group). Patients in Group B will receive 400 mg intravenous ibuprofen administered by the anesthesia research resident 15 minutes before the surgical incision. Group B patients will also receive postoperative intravenous ibuprofen at a dose of 400 mg three times daily. No intraoperative or postoperative ibuprofen treatment will be administered to patients in Group C.

Drug: ibuprofen

CONTROL (GROUP C)

NO INTERVENTION

In this study, patients will be randomized into two groups (Group B: ibuprofen group; Group C: control group). Patients in Group B will receive 400 mg IV ibuprofen administered by the anesthesia research resident 15 minutes before the surgical incision. Group B patients will also receive postoperative IV ibuprofen at a dose of 400 mg three times daily. No intraoperative or postoperative ibuprofen treatment will be administered to patients in Group C.

Interventions

ibuprofen DRUG

In the study, patients in Group B will receive a single intraoperative dose of 400 mg IV ibuprofen, followed by postoperative administration of 400 mg IV ibuprofen three times daily for 24 hours. We hypothesize that, by benefiting from the anti-inflammatory effects of ibuprofen, intraoperative cerebral oxygenation will be preserved, thereby reducing the incidence of postoperative delirium and cognitive dysfunction.

Also known as: IV ibuprofen

IBUPROFEN (GROUP B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-75 years
• American Society of Anesthesiologists (ASA) Physical Status Classification System I-III
• Patients scheduled for lobectomy or segmentectomy via Video-Assisted Thoracic Surgery (VATS ) with one-lung ventilation
• New York Heart Association (NYHA) class I-II
• Patients who have been informed about the study and have provided written informed consent will be included.

You may not qualify if:

• Patients younger than 18 years or older than 75 years
• History of alcohol or substance abuse
• Patients with chronic NSAID use and/or NSAID use within the last 30 days, or NSAID allergy
• Allergy to other drugs used in the study (e.g., bupivacaine)
• ASA Physical Status IV-V
• Severe hearing, visual, or speech impairment
• Dementia, Alzheimer's disease, or psychiatric disorders (psychosis, bipolar disorder, schizophrenia)
• History of previous head trauma
• Chronic liver disease
• Pregnancy
• History of cerebrovascular disease
• Moderate-to-severe chronic obstructive pulmonary disease (COPD) (predicted FEV₁ \<50%)
• GFR \<60 mL/min/1.73 m²
• Patients who do not provide written informed consent
• Conditions that may cause inaccurate cerebral oximetry readings (subdural and/or extracranial hematoma, intracranial arteriovenous shunts, hyperbilirubinemia)

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Related Publications (4)

• Shen L, Chen JQ, Yang XL, Hu JC, Gao W, Chai XQ, Wang D. Corrigendum: Flurbiprofen used in one-lung ventilation improves intraoperative regional cerebral oxygen saturation and reduces the incidence of postoperative delirium. Front Psychiatry. 2023 Jun 6;14:1228369. doi: 10.3389/fpsyt.2023.1228369. eCollection 2023.

  PMID: 37346900 BACKGROUND

• Tang L, Kazan R, Taddei R, Zaouter C, Cyr S, Hemmerling TM. Reduced cerebral oxygen saturation during thoracic surgery predicts early postoperative cognitive dysfunction. Br J Anaesth. 2012 Apr;108(4):623-9. doi: 10.1093/bja/aer501. Epub 2012 Feb 5.

  PMID: 22311364 BACKGROUND

• Hayashi K, Yamada Y, Ishihara T, Tanabe K, Iida H. Comparison of regional cerebral oxygen saturation during one-lung ventilation under desflurane or propofol anesthesia: A randomized trial. Medicine (Baltimore). 2022 Oct 14;101(41):e30030. doi: 10.1097/MD.0000000000030030.

  PMID: 36254073 BACKGROUND

• Liu Z, Jin Y, Wang L, Huang Z. The Effect of Ciprofol on Postoperative Delirium in Elderly Patients Undergoing Thoracoscopic Surgery for Lung Cancer: A Prospective, Randomized, Controlled Trial. Drug Des Devel Ther. 2024 Feb 5;18:325-339. doi: 10.2147/DDDT.S441950. eCollection 2024.

  PMID: 38344256 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Canan ASAR SAHIN

  Ondokuz Mayıs University Faculty of Medicine Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Central Study Contacts

Elif Bengi SENER

CONTACT

+90 (532) 341 67 11; bengimd@gmail.com

Halil CEBECI, Asst. prof.

CONTACT

+(90) 505 387 23 85; halilcebeci55@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: This study is conducted using a parallel-group interventional study model. Eligible participants are randomly assigned in a 1:1 ratio to one of two groups: the ibuprofen intervention group or the control group. Randomization is performed using a computer-generated allocation sequence and implemented via sequentially numbered, opaque, sealed envelopes to ensure allocation concealment. The intervention is applied perioperatively, and participants remain in their assigned group throughout the study with no crossover between groups. Outcomes are assessed and compared between groups in parallel over the defined intraoperative and postoperative follow-up period. The study is designed as prospective, single-center, randomized, controlled, and single-blind, consistent with a parallel assignment model.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 10, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share