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Remimazolam Safety in Elderly Gastrointestinal Endoscopy
NCT05406102Phase 4
Key facts
- Status
- Unknown
- Start
- Jul 2022
- Primary completion
- May 2023
- Countries
- 1
- Sponsor
- First Affiliated Hospital of Xi'an Jiaotong University
- Modality
- Small Molecules
- Drugs
- remimazolam
- Conditions
- Procedural sedation (PS)
01
Overview
Phase 4, randomised trial of remimazolam in Procedural sedation (PS) (2 arms), sponsored by First Affiliated Hospital of Xi'an Jiaotong University. Primary endpoint: Incidence of hypoxemia at 2 hours. Status: unknown.
02
Design
2 arms- Study design
- Randomized
Remimazolam Group
Sufentanil 0.08 ug/kg + Remimazolam 0.1 mg/kg (titrated)
Propofol Group
Sufentanil 0.08 ug/kg + Propofol 1.5 mg/kg (titrated)
03
Who it enrols
Elderly patients (>=60 years) undergoing gastroscopy or gastrointestinal endoscopy with ASA I-III and BMI 18-30 kg/m^2. Excludes patients with respiratory management difficulties, anemia, thrombocytopenia, uncontrolled hypertension, or history of drug/alcohol abuse.
04
Endpoints
Primary
Incidence of hypoxemia
Secondary
Incidence of respiratory depression
Incidence of hypotension
The time of Improved Aldrete >= 9
The time of discharge score >= 9
Postoperative cognitive decline rate
Incidence of postoperative amnesia
Incidence of postoperative anxiety
Incidence of postoperative vertigo
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