Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high. Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,800
Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high.
Renji Hospital
Shanghai, Shanghai, China, China
RECRUITINGShanghai East Hospital
Shanghai, Shanghai, China, China
RECRUITINGAffiliated Hospital of Jiaxing University
Jiaxing, China
RECRUITINGThe Second Affifiliated Hospital of Jiaxing University
Jiaxing, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, China
RECRUITINGThe success rate of remazolam tosylate for sedation in gastroscopy diagnosis and treatment
1\) Complete the entire process of gastroscopy; 2) No sedative remedy is given; 3) After the initial dose of the test drug is administered, additional administration ≤ 2 times within any 5-minute period; 4) The initial dose of propofol After the end, within any 5-minute period of additional administration ≤ 2 times, it is recorded as propofol (control group) successfully sedated
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Sedation induction time
induction time
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Sedation recovery time
recovery time
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Incidence of drug injection pain
drug injection pain
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Doctor satisfaction and patient satisfaction
There is a scale from 1 to 10. Endoscopists and patients will score their satisfaction with the scale ,with 1-3 (dissatisfied),4-6 (satisfied) and 7-10 (very satisfied) after gastroscopy.
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The time it takes for the patient to wake up and leave the hospital if the Sedation/Anaesthesia Discharge Rating Scale score exceeds 9 points;
Sedation/Anaesthesia Discharge Rating Scale
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
The incidence of hypoxia during sedation
(75% ≤ SpO2 \< 90% for \<60 s);(SpO2 \< 75% for any duration or 75% \< SpO2 \< 90% for \>/=60 s)
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other adverse events assessed by the World SIVA adverse sedation event reporting tool
other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force and HFNC supportive oxygen therapy-related adverse events.
Time frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
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