euphoria
Conditions
Interventions
Ciprofol group (Group C):Slowly inject 0.3-0.5 mg/kg of ciprofol intravenously
at the start of the gastrointestinal endoscopy, set the target sedation level to a MOAA/S score of <=1. If the subject experiences body movements or obvious swallowing movements during the procedure,
maintain a sedation depth MOAA/S score <= 2 points during the procedure.
Ciprofol + remazolam 0.05 mg/kg group (Group R1):Slow intravenous injection of 0.3-0.5 mg/kg ciprofol
at the start of gastrointestinal endoscopy, the target sedation level was set to MOAA/S score <= 1 point. After ciprofol anesthesia induction, Group R1 was slowly injected with 0.05 mg/kg of remimazol
the depth of sedation was maintained at MOAA/S score <=2 points during the operation.
Ciprofol + remazolam 0.1 mg/kg group (Group R2):Slow intravenous injection of 0.3-0.5 mg/kg ciprofol
at the start of gastrointestinal endoscopy, the target sedation level was set to MOAA/S score <= 1 point. After induction of anesthesia with ciprofol, Group R2 received a slow injection of 0.1 mg/kg o
sedation depth was maintained at MOAA/S score <= 2 during the procedure.
Sponsors
Northern Jiangsu People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Proposed to perform painless GI endoscopy, and simple endoscopic maneuvers, such as single small polyp clamping, performing Hp tests, and so on; 2. Gender is not limited; 3. 18 years old <= age <= 70 years old; 4. ASA state: I-II; 5. 18kg/m^2< BMI <30 kg/m^2; 6. Informed consent, voluntary participation in the trial, and informed consent signed by the subjects themselves.
Exclusion criteria
Exclusion criteria: 1. Been adjudicated to have difficulty with respiratory management; 2. Participation in a clinical trial of another drug or device within 3 months prior to the Screening Period; 3. Subjects taking medications for psychiatric or neurological disorders (e.g., antidepressants, anxiolytics, convulsants, antiepileptics, etc.) or opioid analgesics, etc., for a variety of reasons (e.g., insomnia, pain, anxiety, etc.) within 3 months prior to the Screening Period; 4. Allergy or contraindication to the study drug or components thereof; 5. The subject has a severe communication impairment due to various reasons such as severe hearing deterioration; 6. Refusal to participate in this study; 7. Other subjects deemed unsuitable by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of euphoria; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of euphoria;Changes in perioperative euphoria;The degree of perioperative euphoria;level of emotion;Pain level;Fatigue condition;Short-term sleep in the 72h postoperative period;Perioperative adverse events;Subjects' satisfaction with the quality of anesthesia;Subjects' dreaming;Postoperative mobility; | — |
Countries
China
Contacts
Public ContactGao Ju
Northern Jiangsu People's Hospital
Outcome results
None listed