NCT06015711

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Aug 2023Dec 2026

First Submitted

Initial submission to the registry

August 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

August 23, 2023

Last Update Submit

September 30, 2025

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

  • Remifentanil requirement

    Intraoperative remifentanil requirement

    3 hours, from incision to skin closure

Secondary Outcomes (1)

  • postoperative analgesic requirement

    1 hour, while in the recovery room

Study Arms (2)

Maxigesic group

EXPERIMENTAL

Administration of Maxigesic before surgery start.

Drug: Maxigesic administration

Control group

NO INTERVENTION

Administration of normal saline before surgery start.

Interventions

Maxigesic administrationDRUG

Preoperative Maxigesic IV administration

Also known as: Preoperative Maxigesic administration
Maxigesic group

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients (19-60 years old) with ASA physical status 1, 2, 3
  • Scheduled surgery under general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

Study Officials

  • In Kyong Yi, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

In Kyong Yi, MD

CONTACT

+82-31-219-5579lyrin01@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assitant professor

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 29, 2023

Study Start

August 30, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

In case of individual reasonable request to PI

Locations

KR(1)