Stefani 1995.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Placebo
Tropisetron
Included criteria: female, ASA I or II Excluded criteria: NA Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear |
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Interventions |
Intervention characteristics Placebo
Tropisetron
|
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Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
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Identification |
Sponsorship source: NA Country: Italy Setting: inpatient, single‐centre Author's name: M. Stefani Institution: Servizi di Anestesia e Terapia del Dolore, Ospedale Regina Apostolorum Alabano Laziale, Roma Email: NA Address: NA Duration of study: NA Language: Italian (translated by Insa Backhaus) Study's primary outcome: NA Trial registry number: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement comment: quote: "with a randomized double‐blind system, the patients were randomly assigned to two groups of 20 people" (translated). No further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: insufficient information on blinding ("double‐blind") |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: insufficient information on blinding ("double‐blind") |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: no missing outcome data |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear |