The Effect of Preoperative Maxigesic® on Intraoperative Remifentanil Requirement

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06015711
• Other study ID #: AJOUIRB-IV-2023-400
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Ajou University School of Medicine
• Contact: In Kyong Yi, MD
• Phone: +82-31-219-5579
• Email: lyrin01[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Intervention

Drug:
• Maxigesic administration
Preoperative Maxigesic IV administration

Locations

Country	Name	City	State
Korea, Republic of	Ajou university school of medicine	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remifentanil requirement	Intraoperative remifentanil requirement	3 hours, from incision to skin closure
Secondary	postoperative analgesic requirement	postoperative fentanyl requirement	1 hour, while in the recovery room