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Effect of different doses of remimazolam on the requirement of propofol and adverse reactions in painless gastrointestinal endoscopy in elderly patients

Effect of different doses of remimazolam on the requirement of propofol and adverse reactions in painless gastrointestinal endoscopy in elderly patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101988
Enrollment
Unknown
Registered
2025-05-07
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

None

Interventions

R0 group:Saline+Intravenous pumping of propofol
R0.05 group:Remimazolam 0.05mg/kg+Intravenous pumping of propofol
R0.10 group:Remimazolam 0.10mg/kg+Intravenous pumping of propofol
R0.15 group:Remimazolam 0.15mg/kg+Intravenous pumping of propofol
R0.20 group:Remimazolam 0.20mg/kg+Intravenous pumping of propofol

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 60-79 years old 2. Elderly patients undergoing gastroenteroscopy under general anesthesia 3. American Society of Anesthesiologists Health Status Classification (ASA Classification) I-II 4. Conscious and able to complete the questionnaires and surveys with the help of medical personnel

Exclusion criteria

Exclusion criteria: 1. Patients with combined mental system diseases, long-term history of taking psychotropic drugs and cognitive dysfunction, such as schizophrenia, mental retardation, mania, insanity, etc. 2. Patients with severe cardiac, pulmonary, hepatic, renal and other systemic pathologies and significant preoperative respiratory or circulatory dysfunction, e.g., severe cardiac arrhythmia, heart failure, A.S. syndrome, unstable angina pectoris, myocardial infarction within the last 6 months, history of tachycardia/bradycardia requiring medication, third-degree atrioventricular block, history of obstructive pulmonary disease, history of bronchospasm requiring treatment within 3 months, acute upper respiratory tract infection within 1 week. Upper respiratory tract infection within 1 week 3. History of regular preoperative use of benzodiazepines and/or opioids, such as diazepam, eszopiclone, midazolam, morphine, oxycodone, fentanyl, etc. 4. active gastrointestinal bleeding in the last week 5. Patients allergic to research drugs, eggs, soy products, opioids and their antidotes, etc. 6. Emergency surgery, hypovolemia, shock or comatose state 7. Patients with estimated airway difficulties, such as those with obstructive sleep apnea syndrome (OSAS) 8. Risk of aspiration 9. Complex endoscopic techniques (e.g. cholangiopancreatography, ultrasonic endoscopy, endoscopic mucosal resection, endoscopic submucosal dissection, transoral endoscopic myotomy, etc.) 10. Patients who are to be extubated 11. Participation as a subject in a clinical trial of another drug within 3 months. 12. Patients who, in the opinion of the investigator, should not be enrolled in this trial.

Design outcomes

Primary

MeasureTime frame
Propofol requirements;EC50 for propofol;Incidence of adverse events;Length of PACU Stay;

Secondary

MeasureTime frame
Success rate of gastroenteroscopy;Time to anesthesia onset;Time to anesthesia emergence;Patient Satisfaction Score;Safety assessment;

Countries

China

Contacts

Public ContactWang Junlu

The First Affiliated Hospital of Wenzhou Medical University

wangjunlu973@163.com+86 138 0668 9854

Outcome results

None listed

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