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NCT Number: NCT06015711

The Effect of Preoperative Maxigesic® on Intraoperative Remifentanil Requirement

Maxigesic is combined intravenous analgesic of ibuprofen and acetaminphen. The purpose of this study is investigate weather preoperative Maxigesic administration can reduce intraoperative remifentanil requirement.

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Key information

Conditions

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location status: Recruiting

Location contact

In Kyong Yi, MD

CONTACT

[email protected]

+82-31-219-5579 ext. 7724

About this study

Remifentanil is an ultra-short-acting opioid that is useful during surgery because of its fast onset and recovery. However, because of this profile, it is known that the use of high doses of remifentanil during surgery paradoxically increases postoperative pain. It has been reported that intraoperative remifentanil use resulted in higher pain scores 2 hours after surgery compared to intraoperative dexmedetomidine, and that the incidence of hypotension, tremor, and postoperative nausea and vomiting were higher in the remifentanil group. Therefore, minimizing the use of remifentanil during surgery is clinically meaningful.

Nonsteroidal anti-inflammatory drugs (NSAIDs) play an important role in multimodal analgesia, and are known to reduce the use of opioids when used together with opioids in postoperative pain [3]. It has also been reported that preoperative administration of ibuprofen reduces postoperative opioid use. Administration of acetaminophen has also been reported to reduce opioid usage. However, there is no study on whether the administration of these NSAIDs and acetaminophen reduces the opioid requirement used during surgery, not after surgery.

The Analgesia nociception index (ANI, MDoloris medical system, France) was developed to measure real-time nociception in patients undergoing surgery under general anesthesia. This index measures parasympathetic nerve activity based on heart rate variability. It is known to be superior in detecting nociceptive stimuli rather than judging only by existing pulse rate and blood pressure. In addition, since information is provided as an objectified numerical value, analgesic drugs can be adjusted during surgery based on this information. This helps to provide an appropriate amount of opioids during surgery when needed, and can prevent overdose. A previous study reported that when ANI-guided remifentanil infusion was performed, the amount of remifentanil used was reduced compared to conventional control of remifentanil only with blood pressure and pulse rate.

Maxigesic® is a combination of acetaminophen and ibuprofen, and is a drug that rapidly relieves various types of pain. It is known to be more effective in relieving postoperative pain than single acetaminophen or ibuprofen. The hypothesis of this study is that administration of Maxigesic®, a combination of acetaminophen and NSAIDs, reduces intraoperative remifentanil requirement. This study aims to investigate whether preoperative Maxigesic® administration can reduce intraoperative remifentanil requirements by performing ANI-guided remifentanil infusion for objective control of remifentanil administration.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maxigesic administration

Drug

Preoperative Maxigesic IV administration

Other names: Preoperative Maxigesic administration

Primary outcomes

  1. Remifentanil requirement

    Time frame: 3 hours, from incision to skin closure

    Intraoperative remifentanil requirement

Secondary outcomes

  1. postoperative analgesic requirement

    Time frame: 1 hour, while in the recovery room

    postoperative fentanyl requirement

Study contacts

Contact information is provided by the study sponsor or research team.

In Kyong Yi, MD

CONTACT

[email protected]

+82-31-219-5579 ext. 7724

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

The Effect of Preoperative Maxigesic® Administration on Analgesic Nociception Index (ANI) Guided Remifentanil Administration

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2023
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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