Opioid UseNCT06015711
The Effect of Preoperative Maxigesic® on Intraoperative Remifentanil Requirement
A study testing Maxigesic administration in people with Opioid Use, run by Ajou University School of Medicine at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Opioid Use
- What is being tested?
- Maxigesic administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Aug 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients (19-60 years old) with ASA physical status 1, 2, 3
- Scheduled surgery under general anesthesia
Who cannot join
- The patient does not conset
- Pregnancy
- hepatic disorder
- Renal disorder
- Asthma
- Hypersensitivity to the NSAIDs or acetaminophen
Show all 11Show fewer
- Patients receiving chronic pain therapy
- Drug dependence
- Patients taking psychiatric drugs
- Alcoholics
- History of gastrointestinal ulcer or bleeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Ajou university school of medicine
Suwon, Gyeonggi-do, 16499
In Kyong Yi, MD, +82-31-219-5579 ext. 7724, lyrin01@gmail.com
About this study
Official title: The Effect of Preoperative Maxigesic® Administration on Analgesic Nociception Index (ANI) Guided Remifentanil Administration
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.
Read the detailed 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.
- Conditions
- Opioid Use
- Being tested
- Maxigesic administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxigesic administrationDrug
Also called Preoperative Maxigesic administration
Preoperative Maxigesic IV administration
| Study group | Role | What they receive |
|---|---|---|
| Maxigesic group | Experimental | Administration of Maxigesic before surgery start. Receives: Drug: Maxigesic administration |
| Control group | No intervention | Administration of normal saline before surgery start. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil requirement
Intraoperative remifentanil requirement
Measured: 3 hours, from incision to skin closure
Secondary outcomes (1)
postoperative analgesic requirement
postoperative fentanyl requirement
Measured: 1 hour, while in the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start30 Aug 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
- Investigators
- In Kyong Yi, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015711
- Sponsor's protocol ID
- AJOUIRB-IV-2023-400
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In case of individual reasonable request to PI
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Maxigesic® Administration on Analgesic Nociception Index (ANI) Guided Remifentanil Administration
- ClinicalTrials.gov ID
- NCT06015711
- Acronym / sponsor ID
- AJOUIRB-IV-2023-400
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxigesic group | Experimental | Drug: Maxigesic administrationAdministration of Maxigesic before surgery start. |
| Control group | No intervention | –Administration of normal saline before surgery start. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients (19-60 years old) with ASA physical status 1, 2, 3
- Scheduled surgery under general anesthesia
Key exclusion criteria (11 listed)
- The patient does not conset
- Pregnancy
- hepatic disorder
- Renal disorder
- Asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maxigesic administrationAlso: Preoperative Maxigesic administrationPreoperative Maxigesic IV administration | Drug | Maxigesic group |
Primary outcome
Remifentanil requirement
Time frame: 3 hours, from incision to skin closure
Intraoperative remifentanil requirement
1 secondary outcome
postoperative analgesic requirement
Time frame: 1 hour, while in the recovery room
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No. In case of individual reasonable request to PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
In Kyong Yi, MD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxigesic administration in people with Opioid Use, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact In Kyong Yi, MD (+82-31-219-5579 ext. 7724, lyrin01@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remifentanil requirement (time frame: 3 hours, from incision to skin closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.