Weren 2008.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis |
|
Participants |
Baseline characteristics Dexamethasone
Methylprednisolone
Placebo
Included criteria: female adult, elective abdominal or gynaecological surgery, informed consent Excluded criteria: pregnancy, lactation, intake of antiemetic drugs within 24 hours preceding surgery and emergency procedure Pretreatment: baseline characteristics (age, BMI): no; (ASA): unclear. Potential effect modifiers (gender, history of PONV): no; (history of motion sickness): unclear; (perioperative opioids, non‐smoker, duration of anaesthesia): yes |
|
Interventions |
Intervention characteristics Dexamethasone
Methylprednisolone
Placebo
|
|
Outcomes |
Vomiting (0 to 2 hours)
Vomiting (2 to 24 hours)
PONV (0 to 24 hours)
|
|
Identification |
Sponsorship source: NA Country: Belgium Setting: inpatient, single‐centre Author's name: Matijn Weren Institution: Kliniek St. Jan, Brussels, Kruidtuinlaan 32, 1000 Brussel Email: matijnweren@yahoo.co.uk Address: UZ Gasthuisberg, Department of Anesthesia, Herestraat 49, 3000 Leuven Language: English Duration of study: NA Trial registry number: NA Study's primary outcome: primary endpoint is to compare dexamethasone and methylprednisolone to placebo for prevention of PONV |
|
Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Judgement comment: "patients were randomized in three groups by a computer generated list" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: "prophylactic anti‐emetic drugs were given according to the randomization in a double‐blind matter. all patients were given a 10 ml intravenous solution at the induction of anaesthesia". Insufficient information on blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: no statement |
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 | High risk | Judgement comment: quote: "there were no significant differences between our 3 groups with regard to age, type of surgery, body mass index (BMI), history of PONV, smoking status, use of N₂O or use of clonidine. Duration of anaesthesia was significantly longer in the methylprednisolone group in comparison with placebo. Significantly more sufentanil was used in the methylprednisolon group in comparison with placebo.Neither the use of sufentanil nor the duration of anaesthesia was significantly different between the two steroid groups" Baseline characteristics (age, BMI): no; (ASA): unclear. Potential effect modifiers (gender, history of PONV): no; (history of motion sickness): unclear; (perioperative opioids, non‐smoker, duration of anaesthesia): yes |