NCT05406102

Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy

Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal : a Multicenter,Randomized Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Gastroenteroscopy diagnosis and treatment drugs need to meet the needs of quick onset, quick recovery and less anesthesia complications. Remimazolam is an anesthetic sedative independently developed by China. It is a new short-acting GABA(A) receptor agonist. Remimazolam has the advantages of rapid onset, rapid recovery, antagonist, controllable degree of cardiovascular and respiratory depression, low incidence of hypotension and respiratory depression. However, elderly patients as important and special patients, there are still a lack of relevant studies and reports. In order to verify the safety and effectiveness of remimazolam in the gastroenteroscopy treatment of elderly patients, it can reduce the incidence of intraoperative hypotension or respiratory depression rate, improve the quality of recovery of elderly patients.

Detailed description

Patients are fasted for at least 6 hours and water for at least 2 hours. After entering the gastroscopic room, patients took 0.1 g of dacronin hydrochloride glue in the throat for about 5 minutes, instructed the patient to be in the left recumbent position and nasal catheter oxygen (4 L / min), finger oxygen and blood pressure ; after static pushing sufentanil 0.08 μg/kg, respectively, give remimazolam or propofol for sedation; MOAA/S score ≤ 3 , start gastrointestinal endoscopy, maintain MOAA/S ≤ 4 during the operation. After the end of gastrointestinal treatment, the patient is moved to the recovery room for recovery. The evaluators also assessed the incidence of blood oxygen saturation \< 90%, the incidence of respiratory rate \< 8 times/min, the incidence of hypotension, the time of improved aldrete≥9, the time of discharge score ≥9 points, the postoperative cognitive function, amnesia, anxiety, dizziness, pain, nausea, and adverse events.

Conditions

• Anesthetics
• Recovery
• Drug Effect
• Safety
• Psychotropic Drugs
• Anesthetics, Intravenous

Interventions

Type	Name	Description
DRUG	Remimazolam	Patients received an initial dose of 0.1mg/kg of remimazolam (add to 0.05 mg/kg top-ups doses to a total of up to five times within 15minutes).
DRUG	Propofol group	Patients received an initial dose of 1.5mg/kg of propofol(add to 0.5 mg/kg top-ups doses to a total of up to five times within 15minutes).

Timeline

• Start date: 2022-07-10
• Primary completion: 2023-05-01
• Completion: 2023-06-01
• First posted: 2022-06-06
• Last updated: 2022-07-01

Locations

9 sites across 1 country: China