Schedule of enrolment, interventions and assessments
Study period | Screening | Allocation | During examination | PACU | Day 1 | Day 3 | Day 7 |
Enrolment: | |||||||
Inclusion criteria | X | ||||||
Exclusion criteria | X | ||||||
Informed consent | X | ||||||
Randomisation | X | ||||||
Demographic data | X | ||||||
Physical examination data | X | ||||||
Interventions: | |||||||
The intervention group | ![]() | ||||||
The control group | ![]() | ||||||
Assessments: | |||||||
Clinical monitoring | |||||||
Vital signs (ECG, HR, MAP, SpO2) | X | X | X | ||||
MOAA/S | X | X | X | ||||
BIS | X | X | |||||
Reference BIS | X | ||||||
Hypoxaemia | X | X | |||||
Time to ambulation | X | ||||||
Airway manoeuvres | X | X | |||||
Rescue sedation | |||||||
Remimazolam tosilate | X | ||||||
Propofol | X | ||||||
Sleep quality (AIS) | X | X | X | X | |||
Sedation failure | X | ||||||
Adverse events | X | X | |||||
Cost of sedatives | X |
AIS, Athens Insomnia Scale; BIS, Bispectral Index; HR, heart rate; MAP, mean arterial blood pressure; MOAA/S, Modified Observer’s Assessment of Alertness and Sedation; PACU, post-anaesthesia care unit; SpO2, pulse oxygen saturation.