Bianchin 2007.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline Characteristics Dexamethasone (group DESA)
Placebo
Included criteria: scheduled for laparoscopic cholecystectomy Excluded criteria: ASA status III and IV, over 80 years or under 20 years of age, endoscopic retrograde cholangiopancreatography within 1 month before operation, chronic pain disorder; history of alcohol abuse, uncontrolled metabolic disease (diabetes mellitus, hypertension), previous PONV for general anaesthesia Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV): no; (history of motion sickness, non‐smoker, perioperative opioids): unclear |
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Interventions |
Intervention characteristics Dexamethasone (group DESA)
Placebo
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Outcomes |
Vomiting (0 to 24 hours)
Nausea (0 to 24 hours)
Subjects with any SAE (postoperatively)
Subjects with any AE (postoperatively)
Postoperative wound infection (postoperatively)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: Italy Setting: inpatient, single‐centre Author's name: A. Bianchin Institution: Anesthesia Department, ASL 8 Asolo, G. Carretta City Hospital, Montebelluna, Treviso, Italy Email: andbia@libero.it Address: Via Marco Polo 25/7, 31031 Caerano S. Marco (TV), Italy Language: English Duration of study: NA Trial registry number: NA Study's primary outcome: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "each patient was allocated randomly to one of the two groups using a computer‐generated random number table" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "patient, anaesthesiologist, surgeon and nurses were all blinded with respect to the study group" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "nurses were all blinded with respect to the study group" Judgement comment: no information on outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "eighty patients were enrolled. Seven were excluded: 4 laparotomic conversions, 2 for anaesthesiological reasons (droperidol, fentanyl over 3 µg/kg), 1 laparoscopic [cholecystectomy and hernioplasty]. Seventy‐three patients have completed the study" |
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, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV): no; (history of motion sickness, non‐smoker, perioperative opioids): unclear |