Postoperative discomfort symptoms of painless gastrointestinal gastroscopy
Conditions
Interventions
Experimental group:remimazolam tosilate in combination with remifentanil was used for 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 inclusion criteria to participate in this study: 1. Subjects aged 18 to 60 years; 2. Subjects of any gender; 3. Subjects who received routine gastroscopy and simple gastroscopy, such as endoscopic polypectomy; 4. Subjects with ASA <= II; 5. 18 kg / m2 < BMI < 30 kg / m2 subjects; 6. Subjects with informed consent voluntarily participated in the trial and signed the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects with any of the following characteristics were excluded from this study: 1. Subjects who need endoscopic diagnosis and treatment techniques with complex operation or high harmful stimulation (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, oral endoscopic myotomy, removal of foreign body from upper digestive tract, ligation of esophageal varices, hemostasis of upper digestive tract, dilation of esophageal stricture, etc.); 2. Subjects whose operation time is expected to be more than 20 minutes; 3. Subjects with severe communication impairment caused by severe hearing deterioration; 4. Subjects who are expected to use other drugs (such as Lugol's solution / indigo carmine / methylene blue / acetic acid) in addition to preoperative preparation, sedation and normal saline for various reasons (e.g. spraying Lugol's solution / indigo carmine / methylene blue / acetic acid during operation) to assist magnifying gastroscopy and early cancer screening; Norepinephrine should be sprayed on the wound to stop bleeding because of the large number of biopsies and large wound; There is atrial fibrillation that is not well controlled before operation, and it is expected that atrial fibrillation with rapid ventricular rate may occur during operation, which needs drug treatment, etc.); 5. Pregnant or lactating women; 6. Patients with history of severe motion sickness and severe vertigo; 7. Patients with malampati grade >= III, neck movement limitation, short distance between nail and chin ( 40% wine Baijiu /150ml). 9. The patients who refused to participate in this study were identified; 10. Patients who participated in clinical trials of other drugs or devices within 3 months before the screening period; 11. Patients who did not elute or take prohibited drugs as shown in Table 1 below; Table 1 forbidden drugs, elution time and forbidden period 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, scobarbital, etc.) >=7d From the beginning of elution time to the end of observation period in this study Anesthetics and Sedatives Propofol, sevoflurane, isoflurane, desflurane, etomidate, ketamine, sodium hydroxybutyrate, etc Analgesics Opioid analgesics (morphine, sufentanil, remifentanil, alfentanil, fentanyl, methadone, oxycodone, dezocine, butorphanol, buprenorphine, codeine, etc.); Non steroidal analgesics (flurbiprofen axetil, diclofenac sodium, celecoxib, meloxicam, etc.); Other analgesics (tramadol, Lappaconitine, Lappaconitine, etc.) antidepressant Tricyclic antidepressants (doxepin, amitriptyline, imipramine, chlorpromazine, etc.); Selective serotonin reuptake inhibitors (fluoxetine, Prozac, paroxetine, salmeterol, fluvoxamine, etc.); Selective serotonin and norepinephrine reuptake inhibitors (bupropion, venlafaxine, etc.) Local anesthetics Lidocaine, procaine, bupivacaine, levobupivacaine, ropivacaine, Dyclonine, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence, severity and duration of 12 major postoperative discomfort symptoms of the subjects: 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), etc.;The incidence, severity and duration of other postoperative discomfort of the subjects;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/ Lliu Xin
Northern Jiangsu People's Hospital Anesthesiology Department
Outcome results
None listed