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Clinical trial

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

ID
Name
AJOUIRB-IV-2023-400
Description
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 arms
Trial start
2023-08-30
Estimated PCD
2024-08-31
Trial end
2024-12-31
Status
Not yet recruiting
Treatment
Maxigesic administration
Preoperative Maxigesic IV administration
Arms:
Maxigesic group
Other names:
Preoperative Maxigesic administration
Size
96
Primary endpoint
Remifentanil requirement
3 hours, from incision to skin closure
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}
Updated at
2023-08-29

1 organization

1 product

1 indication

Organization
Ajou University School of Medicine
Product
Maxigesic
Indication
Opioid Use