Summary of findings 3. Summary of findings (serious adverse events).
| HARM | |||||||
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Patient or population: adults undergoing any type of surgery under general anaesthesia Interventions: antiemetic drugs (monoprophylaxis and combination prophylaxis)* Comparator (reference): placebo (or no treatment) Outcome: serious adverse events (SAEs) Setting: inpatient and outpatient | |||||||
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Total studies: 28 RCTs Total participants: 10,766 Number of treatments: 22 Geometry of the network** |
Relative effect*** (95% CI) |
Anticipated absolute effect **** (95% CI) | Certainty of evidence |
Ranking ***** (P score) |
Interpretation of findings | ||
| Without intervention | With intervention | Difference | |||||
| 5‐HT3 receptor antagonists | |||||||
|
Dolasetron (3 RCTs; 1448 participants) |
0.31 (0.10 to 1.00) |
14 per 10001 | 4 per 1000 | 10 fewer per 1000 (13 fewer to 0 fewer) |
⊕⊕⊖⊖ Low Due to study limitations, imprecision2 |
Rank 1 (0.8229) Rank 14 of 13 single drugs |
Dolasetron may reduce SAEs |
|
Granisetron (2 RCTs; 401 participants) |
1.21 (0.11 to 13.15) |
14 per 10001 | 17 per 1000 | 3 more per 1000 (12 fewer to 170 more) |
⊕⊖⊖⊖ Very low Due to study limitations, imprecision3 |
Rank 16 (0.4612) Rank 10 of 13 single drugs |
We are uncertain whether granisetron increases SAEs |
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Ondansetron (3 RCTs; 833 participants) |
1.62 (0.32 to 8.10) |
14 per 10001 | 23 per 1000 | 9 more per 1000 (10 fewer to 99 more) |
⊕⊖⊖⊖ Very low Due to study limitations, imprecision3 |
Rank 20 (0.3708) Rank 12 of 13 single drugs |
We are uncertain whether ondansetron increases SAEs |
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Palonosetron (3 RCTs; 1319 participants) |
0.71 (0.33 to 1.53) |
14 per 10001 | 10 per 1000 | 4 fewer per 1000 (9 fewer to 7 more) |
⊕⊖⊖⊖ Very low Due to study limitations, imprecision2,3 |
Rank 3 (0.6255) Rank 3 of 13 single drugs |
We are uncertain whether palonosetron reduces SAEs |
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Ramosetron (1 RCT; 236 participants) |
0.89 (0.05 to 15.74) |
14 per 10001 | 12 per 1000 | 2 fewer per 1000 (13 fewer to 206 more) |
⊕⊖⊖⊖ Very low Due to study limitations, imprecision4 |
Rank 8 (0.5366) Rank 7 of 13 single drugs |
We are uncertain whether ramosetron reduces SAEs |
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Tropisetron (2 RCTs; 727 participants) |
0.58 (0.10 to 3.24) |
14 per 10001 | 8 per 1000 | 6 fewer per 1000 (13 fewer to 31 more) |
⊕⊖⊖⊖ Very low Due to study limitations, imprecision3 |
Rank 2 (0.6905) Rank 2 of 13 single drugs |
We are uncertain whether tropisetron reduces SAE |
| D2 receptor antagonists | |||||||
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Amisulpride (2 RCTs; 904 participants) |
0.86 (0.38 to 1.94) |
14 per 10001 | 12 per 1000 | 2 fewer per 1000 (9 fewer to 13 more) |
⊕⊕⊖⊖ Low Due to imprecision2,5 |
Rank 6 (0.5579) Rank 5 of 13 single drugs |
Amisulpride may reduce SAEs |
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Droperidol (2 RCTs; 304 participants) |
0.88 (0.08 to 9.71) |
14 per 10001 | 12 per 1000 | 2 fewer per 1000 (13 fewer to 122 more) |
⊕⊕⊖⊖ Low Due to imprecision5 |
Rank 7 (0.5430) Rank 6 of 13 single drugs |
Droperidol may reduce SAEs |
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Haloperidol (0 RCTs; 0 participants) |
NA | NA | NA | NA | NA | NA | No studies were found that looked at SAEs |
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Metoclopramide (0 RCTs; 0 participants) |
NA | NA | NA | NA | NA | NA | No studies were found that looked at SAEs |
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Perphenazine (0 RCTs; 0 participants) |
NA | NA | NA | NA | NA | NA | No studies were found that looked at SAEs |
| NK1 receptor antagonists | |||||||
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Aprepitant (no direct evidence, indirect evidence only) |
1.39 (0.26 to 7.36) |
14 per 10001 | 19 per 1000 | 5 more per 1000 (10 fewer to 89 more) |
⊕⊖⊖⊖ Very low Due to study limitations, imprecision, incoherence6,7 |
Rank 17 (0.4421) Rank 11 of 13 single drugs |
We are uncertain whether aprepitant increases SAEs |
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Casopitant (No direct evidence, indirect evidence only) |
3.64 (0.57 to 23.11) |
14 per 10001 | 51 per 1000 | 37 more per 1000 (6 fewer to 310 more) |
⊕⊖⊖⊖ Very low Due to study limitations, imprecision, incoherence6 |
Rank 22 (0.1498) Rank 13 of 13 single drugs |
We are uncertain whether casopitant increases SAEs |
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Fosaprepitant (0 RCTs; 0 participants) |
NA | NA | NA | NA | NA | NA | No studies were found that looked at SAEs |
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Rolapitant (0 RCTs; 0 participants) |
NA | NA | NA | NA | NA | NA | No studies were found that looked at SAEs |
| Corticosteroids | |||||||
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Dexamethasone (3 RCTs; 376 participants) |
1.16 (0.28 to 4.85) |
14 per 10001 | 16 per 1000 | 2 more per 1000 (10 fewer to 54 more) |
⊕⊖⊖⊖ Very low Due to study limitations, imprecision3 |
Rank 15 (0.4632) Rank 9 of 13 single drugs |
We are uncertain whether dexamethasone increases SAEs |
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Methylprednisolone (0 RCTs; 0 participants) |
NA | NA | NA | NA | NA | NA | No studies were found that looked at SAEs |
| Antihistamines | |||||||
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Dimenhydrinate (0 RCTs; 0 participants) |
NA | NA | NA | NA | NA | NA | No studies were found that looked at SAEs |
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Meclizine (0 RCTs; 0 participants) |
NA | NA | NA | NA | NA | NA | No studies were found that looked at SAEs |
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Promethazine (0 RCTs; 0 participants) |
NA | NA | NA | NA | NA | NA | No studies were found that looked at SAEs |
| Anticholinergics | |||||||
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Scopolamine (1 RCT; 174 participants) |
0.98 (0.02 to 48.71) |
14 per 10001 | 14 per 1000 | 0 fewer per 1000 (14 fewer to 668 more) |
⊕⊖⊖⊖ Very low Due to study limitations, imprecision4 |
Rank 12 (0.5101) Rank 8 of 13 single drugs |
We are uncertain whether scopolamine has no or minimal effect on SAEs |
| Comparator | |||||||
| Placebo | Reference comparator | Not estimable | Not estimable | Not estimable | Reference comparator |
Rank 14 (0.5020) |
Reference comparator |
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NMA‐SoF table definitions: * Certainty of evidence was assessed only for single antiemetic drugs of direct interest. ** Geometry of the network is presented in Figure 10 (netgraph). *** Network estimates are reported as risk ratio (RR) with confidence interval (CI). **** Anticipated absolute effects. The anticipated absolute effect compares two risks by calculating the difference between risk of the intervention group and risk of the control group. ***** Ranking of treatments includes all single drugs and combinations of drugs and is based on the P score (a value on a continuous 0 to 1 scale), which measures the extent of certainty that a treatment is better than another treatment, averaged over all competing treatments (Supplementary Files‐2‐SAE). Larger P scores indicate better treatments. In addition, the rank of the treatment out of all single drugs is indicated. | |||||||
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GRADE working group grades of evidence (or certainty of the evidence). High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of effect. Very low certainty: we have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect. | |||||||
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Explanatory footnotes: 1 Baseline risks (assumed control risk) are based on the total events of all placebo groups included in the outcome SAEs. The general incidence of SAEs after surgery with placebo is about 1.43%. 2 Poorly connected to the network. Only direct evidence available. 3 Serious concerns for study limitations and very serious concerns for imprecision. 4 Very serious concerns for study limitations and imprecision. 5 Very serious concerns for imprecision. 6 Serious concerns for study limitations and incoherence, and very serious concerns for imprecision. 7 Poorly connected to the network. Aprepitant was directly compared only to ondansetron. | |||||||