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A Comparative Study on the Clinical Effects of Different Doses of Hydromorphone Hydrochloride and Low-dose Esketamine on Catheter-Related Bladder Discomfort in Elderly Male Patients after General Anesthesia

A Study on the Clinical Effects of Different Doses of Hydromorphone Hydrochloride and Low-dose Esketamine on Catheter-Related Bladder Discomfort in Elderly Male Patients after General Anesthesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112701
Enrollment
Unknown
Registered
2025-11-18
Start date
2025-03-18
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Catheter-related bladder irritation syndrome

Interventions

Normal-dose hydromorphinone group:Intravenous injection of 10 µ g/kg of hydromorphinone hydrochloride
Subdose hydromorphinone dose group:Intravenous injection of 6 µ g/kg of hydromorphinone hydrochloride
Subdose esketamine dose group:Intravenous injection of 0.2 mg/kg esketamine
Sham Group:Intravenous saline injection

Sponsors

Affiliated Hospital of Chengdu University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >=65 years old, male; 2.Patients who are scheduled to undergo flexible ureteroscopic lithotripsy under general anesthesia; 3.ASA score of grade II to III; 4. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to hydromorphinone hydrochloride, opioid drugs or ketamine drugs, as well as other components in these drugs; 2. People with mental disorders, those who have been using analgesics, opioids for a long time, and those addicted to opioids; 3. Patients with severe liver and kidney dysfunction, bladder outflow tract obstruction and other diseases; 4.Those who have recently used analgesics, sedatives, or drugs that have a synergistic effect with opioids; 5. Severe disorders of liver and kidney function, heart and lung function, and coagulation function, as well as severe diabetes complicated with diabetic complications; 6. Preoperative admission to the ICU; 7. Concurrent diseases related to immune or nutritional disorders (such as tuberculosis, malignant tumors, hyperthyroidism, etc.); 8.Abnormal urethral anatomy; Bladder dysfunction such as overactive bladder syndrome (urination more than 3 times per night or more than 8 times per 24 hours), neurogenic bladder dysfunction, and bladder outflow tract obstruction; 9. Patients with paralytic ileus.

Design outcomes

Primary

MeasureTime frame
Incidence and severity of CRBD ;The MMSE scores were recorded immediately after extubation (T0), 1 hour after extubation (T1), 4 hours after extubation (T2), 24 hours after extubation (T3), and 48 hours after extubation (T4).;Awakening time;Extubation time;

Secondary

MeasureTime frame
Blood oxygen saturation immediately after extubation (T0), 1 hour after extubation (T1), 4 hours after extubation (T2), immediately after being able to speak and follow instructions (T0), 1 hour after extubation;After extubation, the ability to speak and follow instructions immediately (T0), 1 hour after extubation (T1), 4 hours after extubation (T2), 24 hours after extubation (T3), and 48 hours after extubation;After the tube removal, the patient was able to speak and follow instructions immediately (T0), 1 hour after tube removal (T1), 4 hours after tube removal (T2), 24 hours after tube removal (T3), and 48 hours after extubation;

Countries

China

Contacts

Public ContactShuai Yang

Affiliated Hospital of Chengdu University

m13708183144@163.com+86 137 0818 3144

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 20, 2026