Table 2.
GRADE assessment.
| Remimazolam compared to midazolam for procedural sedation | |||||||
|---|---|---|---|---|---|---|---|
| Certainty assessment | Summary of findings | ||||||
| Participants (studies) Follow up | Risk of bias | Inconsistency | Indirectness | Imprecision | Publication bias | Overall certainty of evidence | Anticipated absolute effects Risk difference |
| Procedure success | |||||||
| 1091 (5 RCTs) | Seriousa | Not serious | Not serious | Not serious | Publication bias strongly suspected b | ⊕⊕◯◯ LOW | 478 more per 1,000 (from 209 more to 598 more) |
| Completion of procedure | |||||||
| 1091 (5 RCTs) | Seriousa | Not serious | Not serious | Seriousc | Publication bias strongly suspectedb | ⊕◯◯◯ VERY LOW | 10 more per 1,000 (from 10 fewer to 19 more) |
| No administration of rescue medication | |||||||
| 1091 (5 RCTs) | Seriousa | Not serious | Not serious | Not serious | Publication bias strongly suspectedb | ⊕⊕◯◯ LOW | 482 more per 1,000 (from 293 more to 535 more) |
| Time to recovery | |||||||
| 1041 (5 RCTs) | Serious a | Not serious | Not serious | Not serious | Publication bias strongly suspectedb | ⊕⊕◯◯ LOW | MD 5.7 fewer (8.68 fewer to 2.72 fewer) |
| Change in cognition recovery of Hopkins Verbal Learning Test-Revised | |||||||
| 209 (2 RCTs) | Seriousa | Not serious | Not serious | Not serious | Publication bias strongly suspectedb | ⊕⊕◯◯ LOW | MD 5.22 higher (2.88 higher to 7.55 higher) |
| Adverse event | |||||||
| 1091 (5 RCTs) | Seriousa | Not serious | Not serious | Seriousc | Publication bias strongly suspectedb | ⊕◯◯◯ VERY LOW | 58 fewer per 1,000 (from 237 fewer to 113 more) |
a
Overall risk of bias by Cochrane Rob 2.0 tool was judged as “some concern”.
b
Asymmetry in Doi plot, and all commercially funded by PAION, UK Ltd with small sample sizes.
c
Insufficient sample size, calculated by trial sequential analysis.