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Clinical observational study of remimazolam tosilate combined with dexmedetomidine and butorphanol for sedation during ERCP in very elderly patients

Clinical observational study of remimazolam tosilate combined with dexmedetomidine and butorphanol for sedation during ERCP in very elderly patients

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049750
Enrollment
Unknown
Registered
2021-08-09
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

endoscopic retrograde cholangiopancreatography

Interventions

remimazolam group:No Intervention
midazolam group:No

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Subjects receiving ERCP; 2. Male or female, ASA class I-II, age 65~ years old; 3. Body mass index (BMI) >=18 and =10 and =90% when inhaling air; SBP>=90 mmHg; DBP>=60 mmHg; heart rate should be >=60 and <=120 times/min; 6. Be able to understand the procedures and methods of this research, be willing to sign the informed consent and strictly follow the clinical research protocol to complete this research.

Exclusion criteria

Exclusion criteria: 1. Elderly patients with epilepsy, glaucoma and enlarged prostate; 2. Those with contraindications to deep sedation/general anesthesia or those who have had a history of sedation/anesthesia accident in the past; 3. Patients who are judged to be difficult to manage the respiratory tract (modified Markov score is grade IV), and the basic blood oxygen saturation is less than 90%; 4. Those with contraindications to routine endoscopic operation; 5. Patients who are considered by the investigator to have any other factors that are not suitable for participating in this clinical study.

Design outcomes

Primary

MeasureTime frame
success rate of procedure sedation;

Secondary

MeasureTime frame
time to adequate sedation;time to fully alert;incidence of respiratory depression;the requirement for sedative rescue medication ( propofol ), the number of dose and total additional dose were compared between the two groups;pain score;patient satisfaction score;

Countries

China

Contacts

Public ContactZhang Fan

Department of Anesthesiology, Renmin Hospital of Wuhan University

zfluck2002@163.com+86 15337193171

Outcome results

None listed

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