TABLE 1.
Timepoint | Study period | ||||||
---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post-allocation | Close-out | ||||
Anesthesia clinic visit | Prior to sedation | During sedation | Sedation emergence | 15 min in recovery room | 30 min in recovery room | Hospital discharge | |
Enrollment | — | — | — | — | — | — | — |
Eligibility criteria | × | — | — | — | — | — | — |
Written informed consent | × | — | — | — | — | — | — |
Demographic data | × | — | — | — | — | — | — |
Baseline characteristics | × | — | — | — | — | — | — |
Randomization | — | × | — | — | — | — | — |
Allocation | — | × | — | — | — | — | — |
Interventions | — | — | — | — | — | — | |
Ciprofol and esketamine | — | × | — | — | — | — | — |
Propofol and esketamine | — | × | — | — | — | — | — |
Ciprofol and placebo | — | × | — | — | — | — | — |
Propofol and placebo | — | × | — | — | — | — | — |
Assessments | — | — | — | — | — | — | — |
Desaturation events | — | — | × | × | × | × | × |
Hypotension events | — | — | × | × | × | × | × |
Severe desaturation | — | — | × | × | × | × | × |
Severe hypotension | — | — | × | × | × | × | × |
Bradycardia | — | — | × | × | × | × | × |
Nausea and vomiting | — | — | — | × | × | × | × |
Dizziness or headache | — | — | — | × | × | × | × |
Hallucination or nightmare | — | — | — | × | × | × | × |
Injection pain | — | — | × | — | — | — | — |
VAS pain scores | — | — | — | × | × | × | — |
VAS fatigue scores | — | — | — | × | × | × | |
Endoscopist satisfaction | — | — | × | — | — | — | — |
Patient satisfaction | — | — | — | — | — | — | × |
According to SPIRIT, 2013 statement of defining standard protocol items for clinical trials.
VAS, visual analog scale.