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Efficacy and safety of Remimazolam Tosilate for injection intravenous anesthesia for painless ERCP: a multicenter, randomized, controlled study

Efficacy and safety of Remimazolam Tosilate for injection intravenous anesthesia for painless ERCP: a multicenter, randomized, controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042946
Enrollment
Unknown
Registered
2021-02-01
Start date
2021-03-10
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

ERCP

Interventions

R Group:Remimazolam Tosilate
F Group :Midazolam combined with etomidate

Sponsors

Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients scheduled for therapeutic ERCP under total intravenous anesthesia; (2) They were 60-89 years old; (3) ASA grade II, III; (4) Sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Severe cardiovascular disease (such as preoperative blood pressure >= 180 / 110mmhg), malignant arrhythmia, myocardial infarction, nhya heart function grade >= III, severe valve insufficiency within 3 months); (2) Severe bradycardia (< 50 beats / min) and severe hypotension (map < 60mmhg) were found; (3) Severe nervous system diseases (such as Parkinson's disease, epilepsy, stroke, intracerebral hemorrhage, etc.) not effectively controlled; (4) Difficult airway and severe respiratory diseases (such as difficult airway, osaha, acute exacerbation of chronic lung disease, asthma exacerbation, SpO2 <= 90% before operation, etc.); (5) A history of long-term or suspected abuse of psychotropic drugs, drug use, and alcohol abuse was identified or suspected; (6) Allergic to narcotic sedative analgesics; (7) Communication barriers, difficult to cooperate; (8) preoperative 6h and fasting or / or 2H * gastric emptying disorders had reached the time of fasting, but gastric retention was still visible under ultrasound.

Design outcomes

Primary

MeasureTime frame
Basic vital signs at each observation time point;Operation time, recovery time, VAS score, satisfaction and other related indicators of recovery period;The dosage of drugs, the success rate of sedation and other sedation related indicators;

Secondary

MeasureTime frame
Recovery of orientation and muscle strength;Safety index evaluation;

Countries

China

Contacts

Public ContactJin-Gui Gao

The Second Hospital of Hebei Medical University

gaojingui@126.com+86 15803210586

Outcome results

None listed

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