General anaesthesia
Conditions
Brief summary
Success rate of general anesthesia induction: A successful general anesthesia induction will meet both of the following conditions: a) Induction success (MOAA/S ≤1) after administration of the study drug, and b) One or less top-up doses required without using any rescue drugs.
Detailed description
The proportion of subjects with any injection-site pain at time of drug administration on the Numeric Rating Scale (NRS ≥1)., The proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, and without significant cardiac and respiratory depression within 15 minutes post initiation start of study drug administration.
Interventions
DRUGMIDAZOLAM
DRUGPROPOFOL
DRUGROCURONIUM BROMIDE
DRUGCipepofol Injectable Emulsion
DRUGFENTANYL
DRUGSEVOFLURANE
Sponsors
Haisco-USA Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of general anesthesia induction: A successful general anesthesia induction will meet both of the following conditions: a) Induction success (MOAA/S ≤1) after administration of the study drug, and b) One or less top-up doses required without using any rescue drugs. | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with any injection-site pain at time of drug administration on the Numeric Rating Scale (NRS ≥1)., The proportion of subjects with successful induction who maintain the desired depth of anesthesia for general elective surgery, and without significant cardiac and respiratory depression within 15 minutes post initiation start of study drug administration. | — |
Countries
Poland, Spain
Outcome results
None listed