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Interventional Effect of Tegilidine Fumarate on Catheter-Related Bladder Discomfort in Male Patients After Transurethral Surgery

Interventional Effect of Tegilidine Fumarate on Catheter-Related Bladder Discomfort in Male Patients After Transurethral Surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126214
Enrollment
Unknown
Registered
2026-06-05
Start date
2026-06-12
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Catheter-Related Bladder Discomfort (CRBD)

Interventions

Control group:An equal volume of normal saline was administered intravenously 30 minutes before the end of surgery.
Tegileridine group:Tegileridine fumarate 1 mg was administered intravenously 30 minutes before the end of surgery.

Sponsors

Chongqing University Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Male patients aged 18–80 years; 2.ASA physical status class I–III; 3.Undergoing elective transurethral resection of bladder tumor under general anesthesia; 4.Body mass index (BMI): 18–30 kg/m²; 5.Fully informed of the trial procedure, voluntary participation in the study, and signed informed consent obtained.

Exclusion criteria

Exclusion criteria: 1.Patients with contraindications to general anesthesia or a history of previous anesthetic accidents; 2.Patients with known or suspected allergy or contraindication to any component of the study drug or routine medications specified in the research protocol; 3.History of drug abuse, alcoholism, or drug dependence; 4.Suspected abuse of narcotic analgesics or sedatives; 5.Complicated with craniocerebral injury, intracranial hypertension, stroke, unstable angina pectoris, or myocardial infarction; 6.History of mental disorders, chronic pain or abnormal pain sensation; 7.Past history of psychiatric diseases or preoperative cognitive impairment; 8.Males in the childbearing preparation period; 9.Participation in any clinical drug trial within 30 days prior to screening; 10.Preoperative urinary tract infection accompanied by symptoms such as frequent micturition, urgent micturition and dysuria; 11.Occurrence of severe intraoperative complications such as reflux aspiration and bronchospasm; 12.Any other conditions deemed inappropriate for participation in this trial by the investigator.

Design outcomes

Primary

MeasureTime frame
The incidence and severity of Catheter-Related Bladder Discomfort (CRBD);

Secondary

MeasureTime frame
Incidence of nausea, vomiting, respiratory depression, dizziness and hypotension within 24 hours postoperatively;Pain scores and sedation scores at 0, 1, 6 and 24 hours postoperatively;Use of rescue medications within 24 hours postoperatively;Patient satisfaction at 6 hours postoperatively;

Countries

China

Contacts

Public ContactQianyun Pang

Chongqing University Cancer Hospital

pqy047417@163.com+86 23 65075689

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026