Preoperative Maxigesic to reduce remifentanil needs during surgery
The Effect of Preoperative Maxigesic® Administration on Analgesic Nociception Index (ANI) Guided Remifentanil Administration
We'll see if giving Maxigesic (intravenous ibuprofen plus acetaminophen) before general anesthesia reduces how much remifentanil adults aged 19–60 need during surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 19 Years to 60 Years |
| Sex | All |
| Sponsor | Ajou University School of Medicine Academic / other |
| Locations | 1 site (Suwon, Gyeonggi-do) |
| Trial ID | NCT06015711 on ClinicalTrials.gov |
What this trial studies
The trial gives adults scheduled for general anesthesia a preoperative dose of Maxigesic (combined IV ibuprofen and acetaminophen) and records intraoperative remifentanil use. Intraoperative nociception and opioid dosing are monitored, with total remifentanil requirement as the main outcome. The Analgesia Nociception Index (ANI), a heart-rate variability–based monitor, is used to track real-time nociception during anesthesia. The study is performed at Ajou University School of Medicine in Suwon among ASA class 1–3 patients aged 19–60.
Who should consider this trial
Good fit: Adults aged 19–60 with ASA physical status 1–3 who are scheduled for surgery under general anesthesia and have no contraindications to NSAIDs or acetaminophen.
Not a fit: People who are pregnant, have liver or kidney disease, asthma, NSAID or acetaminophen allergy, chronic pain or opioid dependence, active alcohol use disorder, psychiatric medication use, or a history of gastrointestinal ulcer or bleeding are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, preoperative Maxigesic could lower intraoperative opioid exposure and reduce postoperative pain and opioid-related side effects.
How similar studies have performed: Prior studies show preoperative ibuprofen or acetaminophen can reduce postoperative opioid use, but using them specifically to lower intraoperative remifentanil requirement is novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (19-60 years old) with ASA physical status 1, 2, 3 * Scheduled surgery under general anesthesia Exclusion Criteria: * The patient does not conset * Pregnancy * hepatic disorder * Renal disorder * Asthma * Hypersensitivity to the NSAIDs or acetaminophen * Patients receiving chronic pain therapy * Drug dependence * Patients taking psychiatric drugs * Alcoholics * History of gastrointestinal ulcer or bleeding
Where this trial is running
Suwon, Gyeonggi-do
- Ajou university school of medicine — Suwon, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Principal investigator: In Kyong Yi, MD — Ajou University School of Medicine
- Study coordinator: In Kyong Yi, MD
- Email: lyrin01@gmail.com
- Phone: +82-31-219-5579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.