None listed
Conditions
Interventions
Drug : Oxycodone 0.1 mg/kg immediately after the end of skin suture, followed by oxycodone 2 mg if body weight is below 80 kg or oxycodone 3 mg if body weight is 80 kg or above.
Sponsors
Mundipharma Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male and female patient at the age of 20 or above. 2) American Society of Anesthesiologist Physical Status 1 or 2. 3) Patient planned to have stomach, colorectal, and hepatobiliary surgery. 4) Patient who signed the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1) Pregnant or lactating woman; pregnancy is defined as the time period from after conception to the end of gestation and is to be confirmed by urine test. 2) Known hypersensitivity reactions to oxycodone or its excipients or any other opioids. 3) Serious respiratory dysfunction or respiratory depression. 4) Current or past treatment with monoamine oxidase inhibitors (MAOIs) within 2 weeks. 5) Convulsive disorder, head injury, decreased level of consciousness of unknown cause, intracranial lesion, increased intracranial pressure, or serious liver injury. 6) Treatment with other Central Nerve System depressants that may induce respiratory depression, hypotension, deep sedation, or coma. 7) Applicable to contraindications for oxycodone as listed in the Investigator’s Brochure or Package Insert. 8) Clinically significant cardiovascular, respiratory, hepatobiliary, or renal impairment. 9) Patient considered by the investigator to be not appropriate for study participation due to other reasons not mentioned in the inclusion/exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MEC and MEAC of Intravenous Oxycodone in Major Intra-abdominal Open Surgeries | — |
Countries
Korea, Republic of
Contacts
Public ContactJeongsim Yang
Asan Medical Center
Outcome results
None listed