Blitz 2012.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis and combination prophylaxis |
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Participants |
Baseline characteristics Palonosetron + dexamethasone
Palonosetron
Included criteria: ASA I and II, 3 or more risk factors for PONV, scheduled to undergo elective outpatient laparoscopic abdominal or gynaecological surgery under general anaesthesia Excluded criteria: pregnant or nursing mothers, received antiemetics within 24 hours of surgery, experienced retching or vomiting within 24 hours before surgery, on long‐term steroid therapy, were immunocompromised, documented allergy to 5‐HT3 receptor antagonists or dexamethasone Pretreatment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker, perioperative opioids): unclear |
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Interventions |
Intervention characteristics Palonosetron + dexamethasone
Palonosetron
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Outcomes |
Vomiting (0 to 2 hours)
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Identification |
Sponsorship source: funding provided by Eisai Inc. Country: USA Setting: outpatient, single‐centre Author's name: Jeanna D. Blitz Institution: Department of Anesthesiology, New York University Langone Medical Centre, New York Email: jeanna.viola@nyumc.org Address: Department of Anesthesiology, New York University Langone Medical Centre, 550 1st Avenue RR 605, New York, NY 10016 Duration of study: NA Language: English Study's primary outcome: complete response Trial registry number: NCT00952133 |
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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: "were randomized". 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: NCT00952133 (retrospective registration) |
Other bias | Unclear risk | Judgement comment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender): no; (history of PONV/motion sickness, duration of anaesthesia, non‐smoker, perioperative opioids): unclear |