Euphoria
Conditions
Interventions
Control group:2mg/kg propofol
1)Induction of anesthesia: propofol 2mg/kg
The target sedation level was set as MOAA/S score <=1, and endoscopists were allowed to perform gastroscopy when the sedation level reached the standard.
2)Maintenance of anesthesia: Propofol 0.5mg/kg
Experimental group 1:Experimental group 1: 0.1mg/kg remimazolam tosilate combined with propofol group.
1)Induction of anesthesia: 0.1mg/kg remimazolam tosilate combined with 2mg/kg propofol.The target
Experimental group 2:Experimental group 2: 0.15mg/kg remimazolam tosilate combined with 2mg/kg propofol group.
1)Induction of anesthesia: 0.15mg/kg remimazolam tosilate combined with 2mg/kg propofol.T
Sponsors
Northern Jiangsu People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1)Painless gastroscopy and simple procedures under gastroscopy, such as single small polyp clamp removal, helicobacter pylori examination, etc; (2)No gender limitation; (3)18 years <= Age <=60 years; (4)ASA:I-II ; (5)18kg/m^2<BMI<30 kg/m^2; (6)No habit of chewing areca nut, or chewing areca nut less than 3 times a week; (7)Informed consent, voluntary participation in the experiment and signed by the subject informed consent.
Exclusion criteria
Exclusion criteria: (1)Long-term smoking or drinking; (2)Those who are judged to have difficulty managing their respiratory tract; (3)The operation time of gastroscopy is expected to be > 20min; (4)History of substance abuse and drug use; (5)Participated in other drug or device clinical trials within 3 months prior to the screening period; (6)Within 3 months prior to the screening period, subjects used therapeutic drugs (such as benzodiazoles, opioid analgesics) that may have an impact on the test results for various reasons (such as insomnia, pain, etc); (7)Allergy or contraindication to the investigational drug or its ingredients; (8)Previous history of mental and neurological disorders (such as schizophrenia, mania, bipolar disorder, insanity, epilepsy, neuralgia, etc.) and the use of corresponding psychiatric and neurological disorders (such as antidepressants, anti-anxiety, convulsive, anti-epileptic drugs, etc.); (9)Pregnant woman; (10)The subjects have serious communication disorders caused by various reasons such as severe hearing degradation; (11)Refused to participate in the study; (12)Deemed unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of euphoria 1;Assessment of euphoria 2;Perioperative euphoric changes;Propofol-related euphoria duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjects' memories of intraoperative dreams;Short-term sleep quality 72h after surgery;Anxiety level;Perioperative adverse events;Subjects' satisfaction with the quality of anesthesia; | — |
Countries
China
Contacts
Public ContactJu Gao
Northern Jiangsu People's Hospital
Outcome results
None listed