Rothenberg 1998.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Droperidol
Dexamethasone
Included criteria: ASA I or II, requiring outpatient gynaecological laparoscopy Excluded criteria: currently receiving antiemetic or corticosteroid therapy; history of immunosuppression, peptic ulcer disease, diabetes mellitus, hypertension, recent tuberculosis, Cushing’s syndrome, or cataracts Pretreatment: baseline characteristics (age, weight, ASA): no. 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 Droperidol
Dexamethasone
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Outcomes |
Vomiting (PACU)
Vomiting (discharge to 24 hours)
PONV (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: USA Setting: outpatient, single‐centre Author's name: David M. Rothenberg Institution: Department of Anesthesiology, Rush‐Presbyterian‐St. Luke's Medical Center, Chicago, Illinois, USA Email: NA Address: Department of Anesthesiology, Rush‐Presbyterian‐St. Luke's Medical Center, 1653 W. Congress Parkway, Chicago, Illinois, USA 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) | Unclear risk | Quote: "the purpose of this randomized..." Judgement comment: no information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "unlabeled numbered aliquots of the study drugs were prepared in equal volumes by an operating room pharmacist without knowledge of the study design" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "within 24 h a blinded observer telephoned each patient to inquire about additional postoperative complications" Quote: "...by a nurse not directly participating in the study" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "five patients (5%) were excluded from data analysis due to the need to perform surgical laparotomy (2 patients) and failure to achieve telephone contact (3 patients). Of the remaining 95 patients, 47 were assigned to the droperidol group, and 48 were assigned to the dexamethasone group" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Quote: "...assigned to the dexamethasone group. There were no differences between the two groups in relationship to patient age, weight, prior episodes of PONV, preoperative history of motion sickness, timing of menses, duration of surgery, amount of IV fluid or vecuronium administered or propofol maintenance dosage (Table 1)..." Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |