Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Treatments: Propofol

Criteria

Inclusion Criteria:

• Age ≥60, no gender limitation;

• Patients receiving gastroscopy or gastrointestinal endoscope;

• ASA physical status score of I to III;

• 18 kg/m² < BMI < 30kg/m²;

• They clearly understand and voluntarily participate in the study and sign informed consent

Exclusion Criteria:

• Endoscopic diagnosis and treatment techniques with complex operation are required;

• Patients with respiratory management difficulties;

• Anemia or Thrombocytopenia;

• Have a history of drug abuse and/or alcohol abuse within 2 years prior to the beginning of the screening period;

• Patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (sital systolic blood pressure ≥160 mmHg at screening stage, and/or diastolic blood pressure ≥100 mmHg at screening stage);

• Allergic or contraindicated to benzodiazepines, opioids, propofol, lidocaine and their components;

• Participated in clinical trials of other drugs as a subject within the last 3 months;

• The investigator considered the patients unfit to participate in the trial.