Wattwil 2003.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Dexamethasone (group D)
Ondansetron (group O)
Included criteria: ASA I to III, 19 to 80 years of age, undergoing breast surgery for carcinoma Excluded criteria: receiving preoperative steroid medication Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids, non‐smoker): no; (history of PONV/motion sickness): unclear |
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Interventions |
Intervention characteristics Dexamethasone (group D)
Ondansetron (group O)
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Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 4 hours)
Vomiting (4 to 8 hours)
Nausea (0 to 24 hours)
Subjects with any AE (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: Sweden Setting: in‐ and outpatient, single‐centre Author's name: M. Wattwil Institution: Department of Anesthesiology and Intensive Care, University Hospital, Örebro, Sweden Email: magnus.wattwil@orebroll.se Address: Department of Anesthesiology and Intensive Care, University Hospital, SE‐701 85 Örebro, Sweden Duration of study: NA Language: English Study's primary outcome: incidence of PONV Trial registry number: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "using computer‐generated random numbers" |
Allocation concealment (selection bias) | Unclear risk | Quote: "using computer‐ generated random numbers inserted into sealed envelopes" Judgement comment: not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "patients were blinded since they received the study drug after induction of anesthesia" Judgement comment: no information on blinding of anaesthesiologist |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "nurses recording episodes of retching or vomiting were not blinded" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "eighty patients were scheduled for the study but two patients in Group D were excluded due to violation of the study protocol (one incorrect premedication and one intubation anesthesia)" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Quote: "demographic data and duration of operation are presented in Table 1. No differences were seen between the groups" Judgement comment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids, non‐smoker): no; (history of PONV/motion sickness): unclear |