Feroci 2011.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Dexamethasone
Placebo
Included criteria: underwent thyroid surgery for benign disease categorized as ASA I and II, weighed 50 kg to 100 kg Excluded criteria: younger than 18 years of age, previous malignant disease, previous thyroid surgery or neck surgery, had received antiemetic therapy within 48 hours before surgery, chronic pain disorder, insulin‐dependent diabetes mellitus, history of severe and/or repeated PONV after previous minor surgery, pregnancy Pretreatment: baseline characteristics (age, ASA): no; (weight): unclear. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear |
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Interventions |
Intervention characteristics Dexamethasone
Placebo
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Outcomes |
Mortality (0 to 48 hours)
Postoperative wound infection (0 to 30 days)
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Identification |
Sponsorship source: NA Country: Italy Setting: inpatient, single‐centre Author's name: Francesco Feroci Institution: General Surgery Unit, Misericordia and Dolce Hospital, Prato, Italy Email: fferoci@yahoo.it Address: NA Language: English Duration of study: January to December 2009 Trial registry number: NCT00888303 Study's primary outcome: primary outcome measure was PONV |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomization was performed by a computer‐generated list of random numbers" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "identical syringes were prepared by staff who were not involved in the study according to the random number list. The patients, anesthetists, and investigators who collected the postoperative data were blinded to the randomization process and to the types of drugs administered" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "investigators who collected the postoperative data were blinded to the randomization process and to the types of drugs administered" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "between January 2009 and December 2009, 114 patients underwent surgery for thyroid disease at our institution. Ten patients were excluded from the randomization according to the following exclusion criteria: 2 patients who had a previous malignant disease, 2 patients who had undergone previous thyroid surgery, 4 patients who had insulin‐dependent diabetes mellitus, and 2 patients because of the lack of any comprehension of the Italian language. Two patients in the control arm were excluded from all analyses due to a postoperative hemorrhage requiring an urgent reparative operation. Therefore, data from 102 patients (51 for each group) were available for the analysis per protocol. One other patient in the dexamethasone group was excluded from subjective voice function analysis due to a verified lesion on the recurrent laryngeal nerve" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: NCT00888303 (retrospective registration) |
Other bias | Unclear risk | Quote: "there were no statistically significant differences between the 2 groups with regard to patient demographics, operation type, postoperative morbidity, and length of stay (Table 1)" Judgement comment: baseline characteristics (age, ASA): no; (weight): unclear. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear |