postoperative discomfort symptoms of painless gastrointestinal gastroscopy
Conditions
Interventions
Experimental group:Using the Remimazolam Tosilate and butorphanol to administer anesthesia
control group:Using the Propofol and butorphanol to administer anesthesia
Sponsors
Northern Jiangsu People's Hospital Anesthesiology Department
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria before they can participate in this study: 1) Aged 18 to 60 years old; 2) patients undergoing routine gastroscopy and simple treatment operation , such as taking pathological specimens; 3) ASA <=level II; 4) BMI 18 to 30 ; 5) informed consent, voluntary participation in the test, and informed consent signed by the patients themselves.
Exclusion criteria
Exclusion criteria: 1) Endoscopic diagnosis and treatment techniques with complex operation or large traumatic stimulation are required (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, oral endoscopic myotomy, removal of foreign bodies in the upper digestive tract, ligation of esophageal varices, hemostasis of the upper digestive tractesophagostenosis and dilation, etc.); 2) the operation time is expected to be more than 20 minutes; 3) the patient has serious communication obstacle caused by serious hearing degradation, etc.; 4) other drugs are expected to be used in operation for various reasons, except for preoperative preparation scheme, sedation scheme and physiological saline (such as Intraoperative spraying of Lugol solution/indigo carmine/methylene blue/acetic acid may assist in magnifying gastroscopy and early cancer screening; it may be necessary to spray norepinephrine on the wound surface to stop bleeding due to the large number of samples taken from the biopsy clip; there is atrial fibrillation that is not well controlled before the operation, and it is expected that rapid ventricular rate atrial fibrillation may occur during the operation, requiring drug treatment, etc.); 5) pregnant or lactating women; 6) the patient has a history of severe vertigo and severe carsickness; 7) subjects with Malampati grade >=III, limited neck movement, short distance between nail and chin ( 40% white spirit / 150ml wine); 9) the patients definitely refuse to participate in this study; 10) the patients have participated in clinical trials of other drugs or devices within three months before the screening period; 11) the patients have not carried out drug elution and taken banned drugs according to table 1 below; Types of drugs Drug name Minimum elution time Forbidden period Sedative hypnotic Benzodiazepines (midazolam, diazepam, etc.), non benzodiazepines (zolpidem, zopiclone, zaleplon, etc.); barbiturates (phenobarbital, isopentobarbital, secobarbital, etc.) >=7d From the beginning of elution time to the end of observation period of this study Anesthetics and Sedatives Tropofol, sevoflurane, isoflurane, desflurane, etomidate, ketamine, sodium hydroxybutyrate, etc Analgesics Opioid analgesics (morphine, sufentanil, remifentanil, alfentanil, fentanyl, methadone, oxycodone, dizosin, butorphanol, buprenorphine, codeine, etc.); non steroidal analgesics (flurbiprofen axetil, diclofenac sodium, celecoxib, meloxicam, etc.); other analgesics Antidepressant Tricyclic antidepressants (doxepin, amitriptyline, promethazine, chlorpromazine, etc.); selective 5-hydroxytryptamine reuptake inhibitors (fluoxetine (Prozac), paroxetine (celet), fluvoxamine (Lan Shi), etc.); selective 5-hydroxytryptamine and noradrenaline reuptake inhibitors (bupropion, venlafaxine, etc.) Local anesthetics: Lidocaine, procaine, bupivacaine, levobupivacaine, ropivacaine, dacronin, etc Antiepileptic: Carbamazepine, gabapentin, pregabalin, lamotrigine, phenytoin, etc. Table 1 forbidden drugs, elution time and forbidden period. 12) The patients could not know whether they had taken the forbidden drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) 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), h;The incidence, severity and duration of other postoperative discomfort of the subjects;3) The change of sleep state after operation of the subjects; | — |
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);In the course of gastroscopy, the incidence and severity of adverse events such as hypotension, hypoxemia, arrhythmia, etc;During the gastroscopy, the additional times of remimazolam 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);Satisfaction score of subjects, drug users and endoscopists for anesthesia process; | — |
Countries
China
Contacts
Public ContactGao Ju
Northern Jiangsu People's Hospital Anesthesiology Department
Outcome results
None listed