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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam group | Experimental | 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. |
|
| Propofol group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remimazolam | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hyoxemia | The proportion of blood oxygen saturation < 90%. | two hours |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Wang | Contact | 0086-02985323646 | dr.wangqiang@139.com | |
| Wei Gao | Contact | 15209225834 | gaowei2906@xjtufh.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Wang | First Affiliated Hospital Xi'an Jiaotong University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Lanzhou University | Lanzhou | Gansu | China | |||
| Affiliated Tumor Hospital of Zhengzhou University |
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|
| Propofol group | Drug | 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). |
|
|
| 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 |
| Zhengzhou |
| Henan |
| China |
| Qinghai University Affiliated Hospital | Xining | Qinghai | China |
| First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | 029710061 | China |
| Shaanxi Provincial People's Hospital | Xi'an | Shaanxi | 029710068 | China |
| Xian Yang Central Hospital | Xi'an | Shaanxi | China |
| Affiliated Hospital of Shaanxi University of traditional Chinese Medicine | Xianyang | Shaanxi | 029712000 | China |
| First Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine | Xinjiang | Xinjiang | China |
| ID | Term |
|---|---|
| C522201 | remimazolam |
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