| Sugar water | Licorice | ||
|---|---|---|---|
| Age (years) | mean (SD) | 58.0 (16.1) | 56.7 (14.9) |
| Sex | Male | 73 (62.4%) | 69 (58.5%) |
| Female | 44 (37.6%) | 49 (41.5%) | |
| Body mass index (kg/m²) | mean (SD) | 25.6 (4.2) | 25.6 (4.3) |
| ASA physical status | I | 19 (16.2%) | 22 (18.6%) |
| II | 67 (57.3%) | 67 (56.8%) | |
| III | 31 (26.5%) | 29 (24.6%) | |
| Mallampati class | I | 31 (26.5%) | 39 (33.1%) |
| II | 69 (59.0%) | 66 (55.9%) | |
| III | 16 (13.7%) | 13 (11.0%) | |
| IV | 1 (0.9%) | 0 (0.0%) | |
| Smoking | Current | 45 (38.5%) | 45 (38.1%) |
| Past | 36 (30.8%) | 36 (30.5%) | |
| Never | 36 (30.8%) | 37 (31.4%) | |
| Sore throat before surgery | No | 115 (98.3%) | 118 (100.0%) |
| Yes | 2 (1.7%) | 0 (0.0%) | |
| Surgery size | Small | 24 (20.5%) | 32 (27.1%) |
| Medium | 83 (70.9%) | 75 (63.6%) | |
| Large | 10 (8.5%) | 11 (9.3%) |
5 Baseline characteristics
All 235 patients in the file are described here, in the arm they were randomized to: 117 sugar water and 118 licorice. No baseline value is missing. Continuous variables are shown as mean (SD) and categorical variables as n (%).
Any differences between randomized arms are due to chance, so there are no significance tests here. Nothing in this table was used to choose covariates for the adjusted analysis. Those were fixed in the plan (Chapter 3; D-009), for the reason given in Chapter 4.
Two baseline facts matter for the pre-specified analyses:
- Only 2 patients had a sore throat before surgery. That is fewer than ten, so by the plan’s rule the variable is left out of the adjusted model (D-011). The primary analysis keeps these patients (D-005).
- No covariate in the adjusted model has a category with fewer than ten patients, so no categories are merged (D-016). Mallampati class is not in any model, so the rule does not apply to it.
No models are fitted in this chapter.