Voigt 2013.
Study characteristics | ||
Methods | RCT | |
Participants | Inclusion criteria:
Exclusion criteria: |
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Interventions | 4 groups: Intervention 1 (group 2): 5HT3 antagonist + dopamine antagonist ‐ not used in this review
Intervention 2 (group 3): antihistamine+corticosteroid ‐ not used in this review
Intervention 3 (group 4): 5HT3 antagonist (Comparison 1)
Comparator (group 1): placebo
We include only group 1 (control) and group 4 Tropisetron alone |
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Outcomes | Nausea and vomiting: intra‐operative; early post‐operative (0–2 hours); late post‐operative (2–24 hours). We include intra‐operative and early post‐operative as per our Methods (data from the earliest time point). | |
Notes | Setting: Evangelian Deaconry Hospital, Freiburg, Germany. Dates: 2010 to 2012 Funding source: not reported Declaration of interest: authors stated “None of the authors have any financial relationships with commercial companies involved with a product in this study”. We will write to the authors and request data separated into nausea and vomiting and for information on the risk of bias assessments. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation method poorly described ("sealed envelopes") |
Allocation concealment (selection bias) | Unclear risk | Although authors report quote: "Sealed opaque envelopes opened by anaesthetist immediately prior to surgery" it is not reported if they were serially numbered. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Data collected by quote: "trained investigators" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | All women appeared to be included in outcome data |
Selective reporting (reporting bias) | High risk | Satisfaction and complications do not appear to be reported as per the Methods. We did not assess the trial protocol. |
Other bias | Unclear risk | Limited methodological information reported. |