GRADE assessment of quality of evidence
| Certainty assessment | No. of patients | Effect | Certainty | Importance | ||||||||
| No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Local anaesthetic with vasoconstrictor | Local anaesthetic without vasoconstrictor | Relative (95% CI) | Absolute (95% CI) | ||
| Mean blood pressure during the procedure (assessed with: mm Hg) | ||||||||||||
| 1 | Randomised trials | Serious * | Not serious | Serious† | Serious‡ | None | 10 | 10 | – | SMD 0.05 SD lower (0.93 lower to 0.82 higher) | ⨁◯◯◯ VERY LOW | IMPORTANT |
| Systolic blood pressure during the procedure (assessed with: mm Hg) | ||||||||||||
| 3 | Randomised trials | Very serious § | Not serious | Serious† | Not serious | None | 55 | 57 | – | SMD 0.39 SD lower (0.8 lower to 0.03 higher) | ⨁◯◯◯ VERY LOW | NOT IMPORTANT |
| Diastolic blood pressure during the procedure (assessed with: mm Hg) | ||||||||||||
| 3 | Randomised trials | Very serious§ | Serious¶ | Serious† | Not serious | None | 55 | 57 | – | SMD 0.51 SD lower (1.07 lower to 0.06 higher) | ⨁◯◯◯ VERY LOW | IMPORTANT |
| Heart rate during the procedure (assessed with: bpm) | ||||||||||||
| 3 | Randomised trials | Very serious § | Not serious | Serious** | Not serious | None | 55 | 57 | – | SMD 0.24 SD lower (0.61 lower to 0.13 higher) | ⨁◯◯◯ VERY LOW | NOT IMPORTANT |
| Mean blood pressure after the procedure (assessed with: mm Hg) | ||||||||||||
| 2 | Randomised trials | Serious†† | Not serious | Serious† | Not serious | None | 38 | 41 | – | SMD 0.26 SD lower (0.71 lower to 0.18 higher) | ⨁⨁◯◯ LOW | IMPORTANT |
| Systolic blood pressure after the procedure (assessed with: mm Hg) | ||||||||||||
| 3 | Randomised trials | Very serious‡‡ | Not serious | Serious† | Not serious | None | 53 | 56 | – | SMD 0.95 SD lower (1.35 lower to 0.55 lower) | ⨁◯◯◯ VERY LOW | NOT IMPORTANT |
| Diastolic blood pressure after the procedure (assessed with: mm Hg) | ||||||||||||
| 3 | Randomised trials | Very serious‡‡ | Serious¶ | Serious† | Not serious | None | 53 | 56 | – | SMD 0.53 SD lower (1.06 lower to 0.01 higher) | ⨁◯◯◯ VERY LOW | IMPORTANT |
| Heart rate after the procedure (assessed with: HR) | ||||||||||||
| 3 | Randomised trials | Very serious*** | Not serious | Serious** | Not serious | None | 55 | 57 | – | SMD 0.2 SD lower (0.57 lower to 0.17 higher) | ⨁◯◯◯ VERY LOW | NOT IMPORTANT |
| Arrhythmia | ||||||||||||
| 3 | Randomised trials | Serious*** i | Not serious | Serious§§ | Serious‡ | None | 12/94 (12.8%) | 6/92 (6.5%) | RR 2.16 (0.87 to 5.41) | 76 more per 1.000 (from 8 fewer to 288 more) | ⨁◯◯◯ VERY LOW | NOT IMPORTANT |
| ST segment depression | ||||||||||||
| 2 | Randomised trials | Serious¶¶ | Serious¶ | Serious*** | Serious††† | None | 7/57 (12.3%) | 6/59 (10.2%) | RR 1.53 (0.17 to 13.72) | 54 more per 1.000 (from 84 fewer to 1.000 more) | ⨁◯◯◯ VERY LOW | NOT IMPORTANT |
*The study was not blinding for outcome assessment. The protocol of the study was not registered previously.
†Blood pressure is a surrogate outcome.
‡Wide CI considering the size of the generated effect.
§Three studies not blinded also allocation not concealment without register of protocols.
¶Moderate heterogeneity without explanation of differences between studies.
**Heart rate is a surrogate outcome.
††One study was not blinded for outcome assessment.
‡‡Two studies from three of them were not blinded.
§§Arrhythmia is a surrogate outcome.
¶¶One study was not blinded for outcome assessment, and two without previous register of protocol.
***ST segment depression is a surrogate outcome.
†††One study with wide CI considering the size of the generated effect.
‡‡‡Three studies without blinding outcome assessment. Two of them not clear to allocation concealment and two without any previous register of protocol.
GRADE, Grading of Recommendations Assessment, Development and Evaluation; RR, risk ratio; SMD, standardised mean difference.