None
Conditions
Interventions
Esketamine group:Esketamine 0.4mg/kg
Nalbuphine group:Nalbuphine 0.2mg
Sponsors
Shanghai Dongfang Hospital
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with an ASA grade III-IV age >= 65 years who intend to undergo ERCP.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of mental illness taking antipsychotic drugs; 2. Damage or disease of the central nervous system; history of epilepsy; 3. Patients with a history of abuse or addiction to anesthetic analgesics or sedatives, such as ketamine or opioids; patients with alcohol abuse; 4. Patients with allergies to dexmedetomidine, esketamine, or soybean or those with contraindications; 5. Patients with visual impairment; patients with inability to elevate intraocular pressure; patients with glaucoma; 6. Concomitant medications prohibited in clinical trials involving esketamine, which may affect efficacy and safety assessments (e.g., aminophylline or theophylline); 7. Use drugs that affect the hepatic and renal metabolism of esketamine, such as hepatic enzyme inhibitors like chlorpromazine; 8. Patients with severe decompensated liver or renal function; 9. Patients at high risk of elevated blood pressure or intracranial pressure; patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic/diastolic blood pressure exceeding 180/100 mmHg); 10. Patients with hyperthyroidism; 11. Unstable angina or myocardial infarction within the past 6 months; a history of severe angina; congestive heart failure; 12. The researchers determine that the subjects, including but not limited to those with impaired major organ functions and/or severe systemic diseases, are unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of hypoxia-related adverse events during sedation: SpO2 < 95%; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe decrease in pulse oxygen saturation (SpO2= 20% of baseline);severe hypertension (MBP increase >= 20% of baseline);The main risk factors for intraoperative respiratory depression; | — |
Countries
China
Contacts
Public ContactXinge Lu
Shanghai Dongfang Hospital
Outcome results
None listed