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The effect of esketamine hydrochloride on intraoperative intestinal peristalsis and postoperative gastrointestinal function recovery in patients with ERCP: A single-center, prospective, randomized, double-blind, controlled study

The effect of esketamine hydrochloride on intraoperative intestinal peristalsis and postoperative gastrointestinal function recovery in patients with ERCP: A single-center, prospective, randomized, double-blind, controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115784
Enrollment
Unknown
Registered
2025-12-31
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Pancreaticobiliary diseases

Interventions

Experimental Group:Esketamine hydrochloride at a dose of 0.3 mg/kg was administered before the operation
Control group:Sufentanil at a dose of 0.1 µ g/kg was administered before the operation, while all other conditions remained unchanged.

Sponsors

General Hospital of Ningxia Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. All patients aged 65-80 who underwent ERCP 2. Patients scheduled for ERCP 3. Voluntarily sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with a history of psychiatric disorders who are taking antipsychotic drugs or narcotic sedative and analgesic drugs; 2. Patients who are allergic to or have contraindications to anesthetic drugs such as propofol, opioids, and esketamine; 3. Use of concomitant medications prohibited in clinical trials of esketamine, which affect efficacy and safety assessments (such as aminophylline or theophylline); 4. Use drugs that affect the hepatic and renal metabolism of esketamine, such as hepatic enzyme inhibitors like chlorpromazine; 5. Patients with severe hepatic and renal dysfunction in the decompensation phase; 6. Have experienced unstable angina pectoris, myocardial infarction, or congestive heart failure within the past 6 months; 7. Patients with any of the following contraindications to the use of esketamine injection: 1) Patients with severe risk of elevated blood pressure or intracranial pressure; 2) Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; 3) Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic blood pressure over 180 mmHg, or resting diastolic blood pressure over 100 mmHg); 4) Patients with untreated or inadequately treated hyperthyroidism; 8. The researcher believes that there are any other reasons that make the patient unsuitable for participating in this study

Design outcomes

Primary

MeasureTime frame
The incidence of intestinal peristalsis and intestinal spasm;The time of the first exhaust, defecation, the first oral meal, and the first time to get out of bed and move around;Incidence of complications;

Secondary

MeasureTime frame
Postoperative cognitive dysfunction;Nausea and vomiting;Hypotension;Respiratory depression;The percentage of successful selective intubation;Intubation time;Measurement result;

Countries

China

Contacts

Public ContactZhenzhou Li

General Hospital of Ningxia Medical University

lizhenzhou3211@163.com+86 150 0867 5282

Outcome results

None listed

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