Schedule of enrolment, interventions and assessments for the trial
Study period | |||||||||||||
Enrolment | Allocation | Postallocation | Follow-up | ||||||||||
Time point* | 1 day before surgery (T0) | Surgery day | T1 | T2 | T3 | T4 | T5 | T6 | T7 | T8 | T9 | T10 | 1 day after surgery (F1) |
Enrolment | |||||||||||||
Eligibility screen | x | ||||||||||||
Informed consent | x | ||||||||||||
Allocation | x | ||||||||||||
Interventions | |||||||||||||
Remimazolam | ![]() | ||||||||||||
Propofol | ![]() | ||||||||||||
Assessments | |||||||||||||
Baseline variables | x | x | |||||||||||
Haemodynamic variables | x | x | x | x | x | x | x | x | x | x | x | ||
Vasoactive drugs consumption | ![]() | ||||||||||||
The number of hypotension or hypertension episodes | ![]() | ||||||||||||
The cumulative duration of hypotension or hypertension | ![]() | ||||||||||||
Rescue drug consumption | ![]() | ||||||||||||
Duration of extubation and awakening | ![]() | ||||||||||||
Adverse event† | ![]() |
*T0: at ward (as baseline), T1: at intubation, T2: 15 min after intubation, T3: the beginning of surgery, T4-7: 15 min, 30 min, 60 min, 90 min after the beginning of surgery, T8: the end of surgery, T9: at extubation, T10: 10 min after extubation.
†Including hallucinations, agitation, delirium, hepatic and renal dysfunction, haematuria, nausea and vomiting, and so on.