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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOndokuz Mayıs University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: IBUPROFEN (GROUP B)Experimental treatment 1 intervention
Group B: CONTROL (GROUP C)No intervention 0 interventions

Trial outcomes

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.

Time frame
preoperative and intraoperative

Secondary outcomes

1

Postoperative cognitive dysfunction (MMSE score)

Cognitive functions in the preoperative and postoperative periods will be assessed using the Mini-Mental State Examination (MMSE) for patients with at least 5 years of education, and the MMSE for uneducated individuals for those with less than 5 years of education. Patients unable to complete the test (total score ≤24) will be excluded from the study.

Time frame
until the end of postoperative day 2 and preoperative day
2

Postoperative delirium score (NU-DESC)

NU-DESC is a delirium screening tool. A total score of 2 or higher will be considered clinically significant for delirium.

Time frame
until the end of postoperative day 2
3

Postoperative Resting and activity NRS score (Numeric Rating Scale)

Patients' pain will be assessed using the Resting and activity NRS (Numeric Rating Scale), scored from 0 to 10. Rescue analgesia will be administered if the score is 4 or higher.

Time frame
until the end of postoperative day 1
4

Postoperative nausea and vomiting status

Nausea and vomiting will be assessed using the Verbal Descriptive Scale (VDS), with scores ranging from 0 to 4. Accordingly, patients with a score of 3 or higher will receive IV ondansetron at a dose of 0.05 mg/kg.

Time frame
until the end of postoperative day 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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