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Efficacy of prophylactic diffenrent sub-anesthetic doses of esketamine on postoperative bladder catheter related discomfort in patients undergoing ureteroscopic litholapaxy: a randomized, double-blind, placebo-controlled study

Efficacy of prophylactic diffenrent sub-anesthetic doses of esketamine on postoperative bladder catheter related discomfort in patients undergoing ureteroscopic litholapaxy: a randomized, double-blind, placebo-controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076262
Enrollment
Unknown
Registered
2023-09-28
Start date
2023-10-01
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

postoperative bladder catheter related discomfort

Interventions

Group A :A single dose of esketamine 0.15 mg /kg in 2 ml normal saline is to inject intravenously 30 minites before the end of the surgery
Group B:A single dose of esketamine 0.25 mg /kg in 2 ml normal saline is to inject intravenously 30 minites before the end of the surgery
group C:2 ml normal saline is to inject intravenously 30 minites before the end of the surgery

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Participants undergoing selective ureteroscopic litholapaxy; 2. Aged 18-65 years old; 3. ASA 1~2; 4. Participants voluntarily participated in the study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Delayed extubation or need to be sent to the ICU for continued monitoring after surgery; 2. Chronic pain or opioid abuse; 3. History of previous urinary tract obstruction requiring surgery; 4. Heart failure (ejection fraction 40); 15. Participnats with hypersensitivity to the active ingredient or all excipients of this product.

Design outcomes

Primary

MeasureTime frame
The incidence of catheter-related bladder discomfort above a moderate grade at 0h postoperatively;

Secondary

MeasureTime frame
The incidence of catheter-related bladder discomfort above a moderate grade at 1h/2h/6h postoperativel;The severity of catheter-related bladder discomfort at 0, 1, 2, and 6h postoperatively;The VAS score at 0, 1, 2, and 6h postoperatively;Sedation scores at 0, 1, 2, and 6 h postoperatively;Postoperative nausea and vomiting during the first 6h after surgery;The hallucination during the first 6h after surgery;Respiratory depression during the first 6h after surgery;Diplopia during the first 6h after surgery;The total sufentanil dosage used during surgery;The rescue tramadol dosage during the first 6h after surgery;The rescue metoclopramide dasage during the first 6h after surgery;Patient satisfaction at 6h postoperatively;

Countries

China

Contacts

Public ContactWang Zhaoli

Peking University Shenzhen Hospital

wzhli86@126.com+86 136 8232 1293

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026