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Safety and efficacy of Esketamine combined with Rimazzolam in endoscopic retrograde cholangiopancreatography assisted by nasopharyngeal airway: A randomized controlled trial.

Safety and efficacy of Esketamine combined with Rimazzolam in endoscopic retrograde cholangiopancreatography assisted by nasopharyngeal airway: A randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116715
Enrollment
Unknown
Registered
2026-01-14
Start date
2026-01-21
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

endoscopic retrograde cholangiopancreatography

Interventions

Experimental group:With nasopharyngeal airway assistance, induction with remimazolam 0.4 mg/kg and esketamine 1 mg/kg, maintenance with remimazolam 1 mg/(kg·h) and esketamine 0.5 mg/(kg·h), maintainin
Control group:Induction with propofol 1 mg/kg and fentanyl 1 µg/kg
maintenance with propofol 4 mg/(kg·h) and fentanyl 12 µg/(kg·h), maintaining a BIS value of 40-60.

Sponsors

Chaohu Hospital Affiliated to Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who undergo diagnostic or therapeutic ERCP (including choledocholithiasis, biliary stricture dilatation/stent implantation, etc.); 2. Age 60 ~ 80 years old; 3.ASA classification I-?; 4. BMI18~28kg/m^2; 5. There is no difficult airway risk in airway evaluation (Mallampati grade I-III, mouth opening >=3cm, neck mental distance >= 6 cm); 6. There is no obvious abnormality in preoperative liver and kidney function, coagulation function and electrocardiogram (or abnormal indicators do not affect anesthesia safety); 7. Voluntary participation and signing of written informed consent can cooperate with postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1. Severe heart, brain, kidney, lung and other organ dysfunction: NYHA heart function grade III-IV, COPDGOLD grade III-IV, EGFR < 30 ml/min/1.73m^2, stroke or myocardial infarction in the last 6 months; 2. Regularly taking benzodiazepines or opioids in the past 3 months; 3. Allergic to propofol, fentanyl, remazolam and other research drugs; 4. ASA classification ?-?; 5. Difficult airway assessment is positive or complicated with severe respiratory diseases (such as severe asthma); 6. Diagnosed mental illness, related family history or cognitive dysfunction (MMSE score < 24); 7. Preoperative resting heart rate < 55 beats/min or degree II or above atrioventricular block; 8. Delayed gastric emptying or high risk of reflux aspiration (such as pyloric obstruction and eating within 4 hours before operation); 9. The patient refuses to participate or the researcher judges that it is not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence rate of intraoperative adverse events;Average blood pressure, heart rate, respiratory rate, and blood oxygen saturation at various time points;

Secondary

MeasureTime frame
Post-awakening pain score;Anesthesia induction time;Awakening event;Incidence of postoperative adverse reactions;

Countries

China

Contacts

Public ContactYu Yongbo

Chaohu Hospital Affiliated to Anhui Medical University

ch2022640014@fy.ahmu.edu.cn+86 183 5519 6892

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026