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Study on the Safety and Comfort of Different Dosages of Remimazolam Combined with Propofol for Painless Digestive Endoscopy in Elderly Patients

Study on the Safety and Comfort of Different Dosages of Remimazolam Combined with Propofol for Painless Digestive Endoscopy in Elderly Patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086792
Enrollment
Unknown
Registered
2024-07-11
Start date
2024-07-15
Completion date
Unknown
Last updated
2024-07-15

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

Conditions

intestinal polyp

Interventions

Propofol group:Induce anesthesia with 1.5mg/kg propofol, adding 0.5mg/kg propofol each time until the subject's MOAA/S score is = 1
Low dose Remimazolam group:0.05mg/kg remimazolam combined with 0.5mg/kg propofol anesthesia induction, with each additional 0.5mg/kg propofol added until the subject's MOAA/S score is = 1
Medium dose Remimazolam group:0.1mg/kg remimazolam combined with 0.5mg/kg propofol anesthesia induction, with each additional 0.5mg/kg propofol added until the subject's MOAA/S score is = 1
High dose Remimazolam group:0.15mg/kg remimazolam combined with 0.5mg/kg propofol anesthesia induction, with each additional 0.5mg/kg propofol added until the subject's MOAA/S score is = 1

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. All patients who are willing to receive sedation/anesthesia through digestive endoscopy for diagnosis and treatment needs. 2. Age = 65 years old. 3. ASA grade I to III patients. 4. 18 = BMI = 30kg/m ². 5. Mentally normal and able to communicate normally. 6. Clearly understand, voluntarily participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Complex surgery requires endoscopic diagnostic and therapeutic techniques (such as endoscopic mucosal resection, endoscopic submucosal dissection, etc.). 2. Patients who require intubation for airway management. 3. Diseases of the circulatory and respiratory systems that may threaten life if not properly controlled. 4. Allergies or contraindications to sedative/anesthetic drugs. 5. Identify patients with difficult airways. 6. Have a history of drug abuse and/or alcoholism. 7. Severe neurological disorders (such as stroke, hemiplegia, convulsions, epilepsy, etc.). 8. I have participated in clinical trials of other drugs as a subject in the past three months.

Design outcomes

Primary

MeasureTime frame
The incidence of hypotension (mean arterial pressure decreased by = 25% from baseline or systolic blood pressure = 90mmHg);

Secondary

MeasureTime frame
Low oxygen incidence rate (SpO2 = 90);Duration of anesthesia induction;Endoscopic operation duration;Awakening time;Anesthesia induction and maintenance of additional medication frequency;Postoperative adverse events;Patient satisfaction;The magnitude of blood pressure drop;

Countries

China

Contacts

Public ContactXuan Zhao

Shanghai Tenth People's Hospital

zhaoxuan301@tongji.edu.cn+86 130 5208 2279

Outcome results

None listed

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