McKenzie 1997.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis and combination prophylaxis |
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Participants |
Baseline characteristics Ondansetron
Ondansetron + dexamethasone
Included criteria: after approval of the Magee‐Women's Hospital Institutional Review Board, informed consent was obtained from 80 women 18 to 65 years of age, who were scheduled for major gynaecological surgery. All women were ASA I, II, or III Excluded criteria: diabetes; had recently (within 24 hours) ingested any other medicine with potential antiemetic properties; had hypersensitivity to soybean, ondansetron, or corticoids; if continuous gastric suction was ordered during the 24‐hour postoperative period Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
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Interventions |
Intervention characteristics Ondansetron
Ondansetron + dexamethasone
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Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 2 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: US Setting: inpatient, single‐centre Author's name: Ray McKenzie Institution: Department of Anesthesiology, Magee‐Womens Hospital, Pittsburgh, PA, USA Email: NA Address: 300 Halket Street, Pittsburgh, PA 15213, USA Language: English Duration of study: NA Trial registry number: NA Study's primary outcome: complete response, defined as no emesis and no administration of rescue antiemetic medication during the 24‐hour postoperative period |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "...each ml of blood lost. The patients were stratified by a positive or negative history of PONV with previous surgery to assure an equal number of patients (n = 20) in each subgroup. After induction of anesthesia and when the patient was stable, ondansetron 4 mg IV was given. Identical syringes of saline (Group 1) or dexamethasone 20 mg (Group 2) were prepared via random number table assignment by personnel not involved in the study. The unknown study drug was administered..." |
Allocation concealment (selection bias) | Low risk | Quote: "...4 mg IV was given. Identical syringes of saline (Group 1) or dexamethasone 20 mg (Group 2) were prepared via random number table assignment by personnel not involved in the study. The unknown study drug was administered IV..." Judgement comment: participants and investigators could not foresee assignment (random number table and syringes generated by personnel not involved in the study) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "after induction of anesthesia and when the patient was stable, ondansetron 4 mg IV was given. Identical syringes of saline (Group 1) or dexamethasone 20 mg (Group 2) were prepared via random number table assignment by personnel not involved in the study. The unknown study drug was administered IV after confirming no change in vital signs. The 24hour study duration began..." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: no statement on blinding of outcome assessors |
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): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |