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A safety study of different dose maintenance regimens of remimazolam versus propofol for anesthesia in painless gastroenteroscopy

A safety study of different dose maintenance regimens of remimazolam versus propofol for anesthesia in painless gastroenteroscopy

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116951
Enrollment
Unknown
Registered
2026-01-16
Start date
2026-01-16
Completion date
Unknown
Last updated
2026-01-27

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

Conditions

Painless gastroscopy and colonoscopy

Interventions

Low-dose remimazolam group:During the maintenance of anesthesia, remimazolam was administered via intravenous infusion at a rate of 0.2 - 0.5 mg/kg/h.
High-dose remimazolam group:During the maintenance of anesthesia, remimazolam was administered via intravenous infusion at a rate of 0.6 - 1 mg/kg/h.
Propofol group:During the maintenance of anesthesia, remimazolam was administered via intravenous infusion at a rate of 3-6 mg/kg/h.

Sponsors

The 963rd Hospital of the Joint Logistic Support Force of the People's Liberation Army of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.elective painless gastrointestinal endoscopy requiring intravenous anesthesia; 2.Age of 18-80 years old, both sexes; 3. ASA grade I-III; 4.Body mass index (BMI) 18.5-28.0kg/m² 5.can understand the relevant information of the trial, sign the informed consent voluntarily, and can cooperate to complete the postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1. Allergic to remimazolam, propofol, or other benzodiazepines 2.patients with severe cardiovascular disease, respiratory system disease, endocrine system disease, liver dysfunction (Child-Pugh C) or renal dysfunction (eGFR < 30mL/min/1.73m²); 3.use of strong central depressants (short-acting opioids, barbiturates, intravenous benzodiazepines, etc.) within 48 hours before surgery or with drug dependence due to long-term use; 4.pregnant or lactating women; 5.patients who may need endotracheal intubation or are identified as high risk of airway management complications by preoperative evaluation; 6. cognitive impairment, psychiatric disorders, or inability to cooperate with clinical assessment; 7.Participants who participated in other clinical trials within the past 3 months;

Design outcomes

Primary

MeasureTime frame
hypotension;

Secondary

MeasureTime frame
hypoxia;respiratory depression;hypertension;tachycardia;bradycardia;intraoperative body movement;supplemental dose of sedative;time to fully alert;endoscopist satisfaction scores;patient satisfaction scores;muscular tremor;postoperative nausea and vomiting;dizziness;blurred vision;agitation ;delirium;hallucinations;Use of vasoactive drugs;Face mask oxygen supply or airway intervention;

Countries

China

Contacts

Public ContactHongxia Xiang

The 963 Hospital of the Joint Support Force

xhx2020616@outlook.com+86 195 4539 1016

Outcome results

None listed

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