Short-term postoperative sleep
Conditions
Interventions
RR group:Remazolam 0.3mg/kg + remifentanil 0.3ug/kg iv
additional remazolam 0.05mg/kg every 5min . If the subject's intraoperative body movement, obvious swallowing movements, etc., additional remazolam 0.05mg/kg by turn until the recovery of stability
remifentanil 0.3ug/kg every 10min
intraoperative maintenance of the depth of sedation MOAA/S score = 2
HR group:Cipofol 0.5mg/kg + remifentanil 0.3µg/kg, iv.
additional cypropofol 0.125mg/kg every 5min. If the subject had intraoperative body movements, obvious swallowing movements, etc., additional cipofol 0.125mg/kg was added one by one until stabilizatio
remifentanil 0.3ug/kg was added every 10min
and the depth of sedation was maintained at a MOAA/S score of =2 during the operation
BR group:Propofol 2.0mg/kg + remifentanil 0.3ug/kg iv
additional propofol 0.5mg/kg every 5min. If the subject's intraoperative body movements, obvious swallowing movements, etc., add propofol 0.5mg/kg one by one until the recovery of stability
add remifentanil 0.3ug/kg every 10min
maintain the depth of intraoperative sedation MOAA/S score = 2.
Sponsors
Northern Jiangsu People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old; 2. Gender is not limited; 3. Patients undergoing routine gastroscopy and simple gastroscopy, such as picking up pathological specimens; 4. ASA grade I-II; 5.18kg/m^2<BMI<30 kg/m^2; 6. Informed consent, voluntarily participate in the trial, and the patient himself signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Required endoscopic diagnosis and treatment techniques with complex operations or large noxious stimuli (such as cholangiopancreatography, ultrasound endoscopy, endoscopic mucosal resection, endoscopic submucosal dissection, oral endoscopic myositation, upper gastrointestinal foreign body removal, esophageal variceal ligation, upper gastrointestinal hemostasis, esophageal stricture dilatation, etc.); 2. The operation time is expected to be > 20min; 3. The patient has severe communication impairment caused by severe hearing deterioration and other reasons; 4. It is expected that other drugs other than preoperative preparation plan, sedation regimen and normal saline will be required during the operation (such as Lugo's solution/indigo rouge/methylene blue/acetic acid-assisted magnification gastroscopy and early cancer screening may be sprayed intraoperatively); It may be due to the large number of biopsy cases and the large wound, and the wound needs to be sprayed with norepinephrine to stop bleeding; Preoperative atrial fibrillation is not well controlled, and it is expected that tachycardial rate atrial fibrillation may occur during surgery, requiring medication, etc.); 5. Pregnant or lactating women; 6. The patient has a history of severe motion sickness and severe vertigo; 7. The subject has limited neck movement, short nail and chin distance ( 40% of liquor/150ml of wine); 9. Patients explicitly refuse to participate in this study; 10. Participated in other drug or device clinical trials within 3 months before the screening period; 11. The patient has not undergone prohibited drug washout and taken prohibited drugs;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence, severity and duration of 12 major postoperative discomfort symptoms of the subjects. The 12 main symptoms were: nausea, vomiting, dizziness (the feeling of peripheral environment or self rotation, movement, shaking), drowsy (the feeling of drowsy, lightness of head and feet, and not refreshing), headache;The incidence, severity and duration of other postoperative discomfort of the subjects;Postoperative sleep;During the gastroscopy, the additional times of remimazolam, cipropol and propofol (refers to the times of temporary addition due to the non-standard body movement and sedation depth during the operation);Time of sedation and recovery (from the time of last sedative administration to the Aldrete>= 9);n the course of gastroscopy, the incidence and severity of adverse events such as hypotension, hypoxemia, arrhythmia, etc;Satisfaction score of subjects, drug users and endoscopists for anesthesia process; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sedation success rate (sedation success is defined as the completion of the whole gastroscope diagnosis and treatment operation, without the occurrence of other circumstances that meet the sedation failure standard, such as receiving sedative remedy drugs; sedation success rate is the proportion of sedation successful;Sedation induction time (from the beginning of sedation administration to the beginning of gastroscopy, or from the beginning of sedation administration to the MOAA/S score <=1); | — |
Countries
China
Contacts
Public ContactLiu Xin
Northern Jiangsu People's Hospital
Outcome results
None listed