Efficacy and Safety Profile of Remimazolam-alfentanil Combination for ERCP Sedation

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Moderate to deep levels of sedation and analgesia are required for ERCP. Propofol-based sedation is simple, easy to use, and effective, but is not without cardiovascular and respiratory adverse effects. The combination of remimazolam and alfentanil has shown promising results for sedation in other similar scenarios. The aim of this study was to compare the efficacy and safety of a standard propofol-alfentanil regimen with a remimazolam-alfentanil combination.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Nankai Hospital
• Treatments: Alfentanil; Propofol

Criteria

Inclusion Criteria:

• Age is between 18 and 85 years

• ASA I and II levels;

• Patients undergone elective ERCP surgery, non-intubation patients;

Exclusion Criteria:

• Chronic pain with long-term use of analgesics, psychotropic substances (including opioids, NSAIDs, sedatives, antidepressants), alcohol abusers, with known drug allergy;

• 15 percent of body weight below or above standard weight;

• Abnormal liver or renal function (ALT、AST、BUN or Cr ) ;

• Previous abnormal surgical anesthesia recovery history;

• Hypertension or systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 95 mmHg when the patient admission to the operating room

• Suffering from esophageal reflux;

• Sedatives, analgesics and antipruritic drugs were used 24 hours before operation;

• Expected difficult intubation ;

• Liver surgery history;

• Opioids allergy history;

• Take monoamine oxidase inhibitor or antidepressant within 15 days;

• Shock;

• COPD;

• Pregnant or parturient women;

• Involved in other drug trials within three months;

• Patients who can not communicate well with the researcher