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Effects of different doses of remazolam combined with afentanil on hemodynamics during induction in elderly patients with ERCP

Effects of different doses of remazolam combined with afentanil on hemodynamics during induction in elderly patients with ERCP: a single-center, randomized, dose-controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090855
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-10-15
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

endoscopic retrograde cholangiopancreatography

Interventions

R1 group (Remazolam 0.15mg/kg group):Anesthesia induction: Slowly intravenous injection of afentanil 5ug/kg, 30s later, slowly intravenous injection of remazolam 0.15mg/kg Anesthesia maintenance: Rema
R2 group (Remazolam 0.20mg/kg group):Anesthesia induction: Slowly intravenous injection of afentanil 5ug/kg, 30s later, slowly intravenous injection of remazolam 0.20mg/kg Anesthesia maintenance: Rema
R3 group (Remazolam 0.25mg/kg group):Anesthesia induction: Slowly intravenous injection of afentanil 5ug/kg, 30s later, slowly intravenous injection of remazolam 0.25mg/kg Anesthesia maintenance: Rema

Sponsors

Chinese People's Liberation Army Northern Theater Command General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
75 Years to No maximum

Inclusion criteria

Inclusion criteria: a. Age > 75 years old for ERCP surgery; b.ASA Grade I-III; c. Body mass index (BMI) 18-30 kg/m2; d. The anesthesia method was MAC anesthesia; e. Willing to sign informed consent and strictly follow the clinical study protocol.

Exclusion criteria

Exclusion criteria: a. Circulatory diseases (heart failure, angina pectoris, myocardial infarction, arrhythmia); b. uncontrolled hypertension (systolic =160 mmHg or diastolic =100 mmHg) or hypotension (systolic =90 mmHg or diastolic =60 mmHg); (c) Respiratory diseases (acute respiratory infections, asthma attacks, bronchitis, chronic obstructive pulmonary disease); A D.Allampati score of 3 or 4; e. Liver insufficiency: Child-Pugh grade C or above; f. Renal insufficiency: glomerular filtration rate 2.5 mg/dL; g. Anemia or thrombocytopenia (hemoglobin < 90 g/L, platelet count <80×109 /L); h. Modified Allen test negative; i. Those who are allergic to experimental drugs drink alcohol or use psychotropic drugs or painkillers for a long time; j. Patients with previous history of anesthesia and sedation accidents and contraindications; Participants in clinical trials of other drugs within the last three months.

Design outcomes

Primary

MeasureTime frame
Mean arterial pressure;

Secondary

MeasureTime frame
Heart rate;Blood oxygen saturation;bispectral index;Dosage of norepinephrine;Bradycardia (HR 1min);hiccup;Injection pain;Time of loss of consciousness (from the first infusion of remazolam to MOAA/S score =1 and BIS<60);Additional sedation cases;

Countries

CHNIA

Contacts

Public ContactDandan SONG

Chinese People's Liberation Army Northern Theater Command General Hospital

songdandan6@163.com+86 177 9099 3788

Outcome results

None listed

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