Table 1.
The study schedule for enrollment, treatments, outcome measurements, and data collection.
| Study period | |||||||||
| Timepoint | Enrollment | Allocation | Post-allocation | ||||||
| Pre-2 | 0 | Pre-1 (t0) | Pod-0 (t1-t2) | Pod-1 (t3) | Pod-2 (t4) | Pod-3 (t5) | Pod-5 (t6) | Pod-30 (t7) | |
| Enrollment | |||||||||
| Inclusion criteria | ☑ | ||||||||
| Exclusion criteria | ☑ | ||||||||
| Informed consent | ☑ | ||||||||
| Randomization | |||||||||
| Allocation | ☑ | ||||||||
| Interventions | |||||||||
| Active-taVNS group | ☑ | ☑ | ☑ | ||||||
| Sham taVNS group | ☑ | ☑ | ☑ | ||||||
| Outcome measurement | |||||||||
| ALT | ☑ | ☑ | ☑ | ||||||
| AST | ☑ | ☑ | ☑ | ||||||
| TBA | ☑ | ☑ | ☑ | ||||||
| DBIL | ☑ | ☑ | ☑ | ||||||
| TBIL | ☑ | ☑ | ☑ | ||||||
| BUN | ☑ | ☑ | ☑ | ||||||
| Cr | ☑ | ☑ | ☑ | ||||||
| IL-6 | ☑ | ☑ | |||||||
| TNF-α | ☑ | ☑ | |||||||
| FRAIL | ☑ | ||||||||
| NRS | ☑ | ☑ | ☑ | ☑ | |||||
| CAM | ☑ | ☑ | ☑ | ☑ | ☑ | ||||
| SAS | ☑ | ☑ | ☑ | ☑ | ☑ | ||||
| I-FEED | ☑ | ☑ | ☑ | ☑ | |||||
| FSS | ☑ | ☑ | ☑ | ☑ | ☑ | ||||
| QoR-15 | ☑ | ☑ | ☑ | ☑ | ☑ | ||||
| Adverse events | ☑ | ☑ | ☑ | ☑ | ☑ | ☑ | ☑ | ||
According to SPIRIT 2013 statement: defining standard protocol items for clinical trials. Pre, preoperative day; Pod, postoperative day; ALT, Alanine aminotransferase; AST, Aspartate aminotransferase; TBA, Total bile acids; TBIL, Total bilirubin; DBIL, Indirect bilirubin; BUN, Blood Urea nitrogen; Cr, Creatinine; IL-6, Interleukin-6; TNF-α, tumor necrosis factor-α; FRAIL, Fatigue, Resistance, Ambulation, Illness and Loss of Weight Index; NRS, Numerical Rating Scale; CAM, The Confusion Assessment Method; SAS, Simpson-Angus Scale; IEED, Intake, feeling nauseated, emesis, exam and duration of symptoms; FSS, Fatigue Severity Scale; QoR-15, Quality of Recovery-15.