Effect of Opiranserin on catheter related bladder discomfort in patients undergoing transurethral resection of bladder tumor

Effect of Opiranserin on catheter related bladder discomfort in patients undergoing transurethral resection of bladder tumor : a randomized, double-blind, placebo-controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0011555

Enrollment

140

Registered

2026-01-30

Start date

2026-02-18

Completion date

Unknown

Last updated

2026-02-09

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

Conditions

None listed

Interventions

Drug : Following the induction of general anesthesia, a solution containing 1,000 mg of Opiranserin diluted in 500 ml of normal saline (concentration: 2 mg/ml) will be prepared for the experimental gr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing Transurethral Resection of Bladder Tumor (TURB) under general anesthesia Patients aged 20 to less than 80 years Patients with American Society of Anesthesiologists (ASA) physical status class I to III Patients who have voluntarily provided written informed consent to participate in this clinical study

Exclusion criteria

Exclusion criteria: Conversion to open surgery Patients with a history or current diagnosis of overactive bladder, neurogenic bladder, or bladder outflow obstruction Patients with a known history of hypersensitivity to Opiranserin or any of its components Uncontrolled cardiovascular disease: Systolic blood pressure < 90 mmHg, myocardial infarction within the last 3 months, unstable angina, or severe arrhythmia Severe hepatic or renal impairment Pregnant or lactating women Patient refusal

Design outcomes

Primary

Measure	Time frame
Catheter related bladder discomfort at postoperative 0 hours	—

Secondary

Measure	Time frame
Catheter related bladder discomfort at postoperative 1 hours;Catheter related bladder discomfort at postoperative 2 hours;Catheter related bladder discomfort at postoperative 6 hours;Numeric rating scale assessed at postoperative 0 hours;Numeric rating scale assessed at postoperative 6 hours;The patients' satisfaction assessed at postoperative 6 hours;Total analgesic consumption during the first 24 hours after surgery;Postoperative complication related Opiranserin;Delirium assess	—

Measure

Time frame

Catheter related bladder discomfort at postoperative 1 hours;Catheter related bladder discomfort at postoperative 2 hours;Catheter related bladder discomfort at postoperative 6 hours;Numeric rating scale assessed at postoperative 0 hours;Numeric rating scale assessed at postoperative 6 hours;The patients' satisfaction assessed at postoperative 6 hours;Total analgesic consumption during the first 24 hours after surgery;Postoperative complication related Opiranserin;Delirium assess

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Countries

Korea, Republic of

Contacts

Public ContactJun-Young Park

Asan Medical Center

parkjy@amc.seoul.kr+82-2-3010-3868

Outcome results