Gastric disease
Conditions
Interventions
Group C:Intravenous injection of sufentanil was 0.1µg /kg (infusion time 10 s), and intravenous infusion of cipofol was 0.4 mg/kg (infusion time not less than 30s) 1min later. MOAA/S score was perform
Group EP:Intravenous injection of Sufentanil 0.1µg /kg (infusion time 10 s), 1min later intravenous injection of remazolam 0.3mg /kg (infusion time not less than 30s). MOAA/S score was performed every
Sponsors
Wuhan University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Subjects receiving gastroscopy; 2) Male or female, ASA grade I-II, age = 18 years and < 65 years; 3) Body mass index (BMI) =18 and < 30 kg/m2; 4) The respiratory rate in the screening period and the baseline period should be =10 and =24 times/min; SpO2 suction air should be = 95%; SBP = 90 mmHg; DBP = 60 mmHg; Heart rate should be = 60 and = 100 beats/min; 5) Able to understand the procedures and methods of this study, willing to sign informed consent and strictly follow the clinical study protocol to complete this study.
Exclusion criteria
Exclusion criteria: 1) Patients with contraindications to deep sedation/general anesthesia or who have a history of sedation/anesthesia accidents in the past; 2) People who are known to be allergic to cyclopofol, remazolam, opioids and their relief drugs; Contraindications of cyclopofol, remazolam, opioids and their relief drugs; 3) Individuals with contraindications for routine endoscopic procedures; 4) Researchers believe that patients with any other factors that are not suitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of successful sedation/anesthesia induction (the time from the first initiation of the study drug to the first modification of the investigator's wakefulness/sedation score (MOAA/S) =1);Success rate of the first dose of sedation (modified investigator wakefulness/sedation score (MOAA/S) =1 can be achieved after the first dose of study drugs, no additional drugs are required);Full wakefulness duration;Duration of absence from the chamber (from the end of the last dose to the first occurrence of 3 consecutive absence scores (Aldrete score) =9);Incidence of respiratory adverse events (respiratory depression, apnea, hypoxemia, cough, hiccup) during diagnosis and treatment;;Incidence of hypotension requiring intervention (SBP 2min, therapeutic drugs: dopamine, norepinephrine) and bradycardia (HR < 50 beats/min, therapeutic drugs: atropine, epinephrine);Evaluation of injection pain;Occurrence and severity of nausea, vomiting and vertigo when leaving the room;Evaluation of doctor-patient satisfaction;Records of other anesthesia related adverse events (body movements, dreams, etc.); | — |
Countries
China
Contacts
Public ContactLei shaoqing
Wuhan University People's Hospital
Outcome results
None listed