Preemptive versus Postoperative Administration of Opiranserin in Patients Undergoing Laparoscopic Gastrectomy

Preemptive versus Postoperative Administration of Opiranserin in Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012148

Enrollment

130

Registered

2026-06-19

Start date

2026-06-23

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Participants will be randomly assigned to either the preemptive group or the postoperative group. Both groups will receive the same dose and regimen of opiranserin, and the only difference betw

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients aged 19 years or older undergoing laparoscopic or robot-assisted gastrectomy

Exclusion criteria

Exclusion criteria: • History of allergy or adverse reactions to medications • Unstable angina, congestive heart failure, or electrocardiographic findings of QRS > 200 ms or QTcF > 450 msec • Moderate-to-severe renal impairment • Moderate-to-severe hepatic impairment • Current use of medications known to prolong the PR or QRS interval • Current use of strong CYP3A4 inhibitors • Chronic pain requiring analgesic medication • Cognitive impairment • Pregnant or breastfeeding women • Inability to understand the informed consent form

Design outcomes

Primary

Measure	Time frame
Opioid consumption during the 24 hours after surgery	—

Secondary

Measure	Time frame
Postoperative opioid consumption ;Postoperative pain scores;AUC (Area Under the Curve) of postoperative pain scores;Pain sensitivity (MPT, WUR, Pain score at a standardized stimulus);Postoperative PCA demands;Requirement for rescue analgesics;Time to first rescue analgesic ;Postoperative nause and vomiting;Intraoperative opioid consumption ;Intraoperative vital signs, ANI (Analgesia Nociception Index), PSI (Patient State Index), EEG features	—

Measure

Time frame

Postoperative opioid consumption ;Postoperative pain scores;AUC (Area Under the Curve) of postoperative pain scores;Pain sensitivity (MPT, WUR, Pain score at a standardized stimulus);Postoperative PCA demands;Requirement for rescue analgesics;Time to first rescue analgesic ;Postoperative nause and vomiting;Intraoperative opioid consumption ;Intraoperative vital signs, ANI (Analgesia Nociception Index), PSI (Patient State Index), EEG features

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Countries

Korea, Republic of

Contacts

Public ContactMyung Il Bae

Yonsei University Health System, Gangnam Severance Hospital

bmi87@yuhs.ac+82-2-2019-3520

Outcome results