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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
300
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).
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).
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Affiliated Tumor Hospital of Zhengzhou University
Zhengzhou, Henan, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China
Xian Yang Central Hospital
Xi'an, Shaanxi, China
Affiliated Hospital of Shaanxi University of traditional Chinese Medicine
Xianyang, Shaanxi, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine
Xinjiang, Xinjiang, China
Incidence of hyoxemia
The proportion of blood oxygen saturation \< 90%.
Time frame: two hours
Incidence of respiratory depression
The incidence of respiratory rate \< 8 times/min
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: two hours
Postoperative cognitive decline rate
Changes in MOCA score before and after surgery
Time frame: two hours
Incidence of postoperative amnesia
incidence of anterograde and retrograde amnesia
Time frame: two hours
Incidence of postoperative anxiety
incidence of patients with generalized Anxiety Disorder Scale (GAD-7) score ≥ 10
Time frame: two hours
Incidence of postoperative vertigo
incidence of vertigo patients
Time frame: two hours
Incidence of postoperative pain
incidence of patients with visual analogue scale (VAS) ≥ 4
Time frame: two hours
Adverse events
abnormal clinical symptoms and vital signs, and abnormalities in laboratory tests
Time frame: two hours
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