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. 2021 May 18;2021(5):CD007579. doi: 10.1002/14651858.CD007579.pub3

Voigt 2013.

Study characteristics
Methods RCT
Participants Inclusion criteria:
  • Women undergoing elective CS under spinal anaesthesia

  • N = 308 women randomised, none excluded after randomisation but we only included 2 groups in our analysis so 147 women were included in our analysis


Exclusion criteria:
Interventions 4 groups:
Intervention 1 (group 2): 5HT3 antagonist + dopamine antagonist ‐ not used in this review
  • Tropisetron+metoclopramide

  • N = 82


Intervention 2 (group 3): antihistamine+corticosteroid ‐ not used in this review
  • Dimenhydrinate+dexamethasone

  • N = 79


Intervention 3 (group 4): 5HT3 antagonist (Comparison 1)
  • Tropisetron alone,

  • 4mg given after cord clamping

  • N = 71


Comparator (group 1): placebo
  • no prophylaxis

  • N = 76


We include only group 1 (control) and group 4 Tropisetron alone
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.
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.