Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Remimazolam
* Drug: Propofol group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remimazolam group<br>Patients were slowly injected of 0.08 ug/kg of sufentanil. Patients received remimazolam 0.1mg/kg to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. | Drug: Remimazolam<br>* 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).<br>* Other names: experimental;|
| Active Comparator: Propofol group<br>Patients were slowly injected of 0.08 ug/kg of sufentanil for 1 min during the examination.Patients received Propofol 1.5mg/kg to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure. | Drug: Propofol group<br>* 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).<br>* Other names: active comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hyoxemia | The proportion of blood oxygen saturation < 90%. | two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of respiratory depression | The incidence of respiratory rate < 8 times/min | two hours | 
| Incidence of hypotension | The incidence of systolic blood pressure decreased by more than 20% before sedation or systolic blood pressure decreased to ≤ 80 mmHg. | two hours | 
| The time of Improved Aldrete≥9 | improved Aldrete≥9 was evaluated every 1 min after the last administration, and the time from the last administration to improved Aldrete score ≥9 . | two hours | 
| The time of discharge score ≥9 | the discharge score was evaluated every 3 minutes after the modified Aldrete≥9, and the time from the last administration to the discharge score ≥9. | two hours | 
| Postoperative cognitive decline rate | Changes in MOCA score before and after surgery | two hours | 
| Incidence of postoperative amnesia | incidence of anterograde and retrograde amnesia | two hours | 
| Incidence of postoperative anxiety | incidence of patients with generalized Anxiety Disorder Scale (GAD-7) score ≥ 10 | two hours | 
| Incidence of postoperative vertigo | incidence of vertigo patients | two hours | 
| Incidence of postoperative pain | incidence of patients with visual analogue scale (VAS) ≥ 4 | two hours | 
| Adverse events | abnormal clinical symptoms and vital signs, and abnormalities in laboratory tests | two hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remimazolam, Elderly, Endoscopes, Gastrointestinal, Propofol