Table 2.
Study Period | ||||||
---|---|---|---|---|---|---|
Enrollment | Allocation | Post-Allocation | Close-Out | |||
Timepoint | Anesthesia Clinic Visit | Prior to Sedation | During Sedation | Emergence from Sedation | 15 Min in Recovery Room | Hospital Discharge |
Patient enrollment | ||||||
Inclusion criteria | × | |||||
Exclusion criteria | × | |||||
Written informed consent | × | |||||
Demographic data | × | |||||
Baseline characteristics | × | |||||
Randomization | × | |||||
Allocation | × | |||||
Study interventions | ||||||
Esketamine | × | |||||
Normal saline placebo | × | |||||
Endpoint measurements | ||||||
Desaturation events | × | |||||
Hypotension events | × | |||||
Total dose of propofol | × | |||||
NRS pain scores | × | × | ||||
NRS fatigue scores | × | × | ||||
Dizziness | × | × | × | |||
Hallucination or nightmare | × | × | × | |||
Nausea and vomiting | × | × | × | |||
Endoscopist satisfaction | × | |||||
Patient satisfaction | × |
Abbreviation: NRS, numerical rating scale.