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. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Weren 2008.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis
Participants Baseline characteristics
Dexamethasone
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 38

  • Received treatment (n): NA

  • Analysed (n): 38

  • Age (mean ± SD, median (IQR), median (range)): 45.03 ± 16.07

  • Weight (mean ± SD, median (IQR), median (range)): NA

  • BMI (mean ± SD, median (IQR), median (range)): 28.05 ± 10.50

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): 86.85

  • History of PONV/motion sickness (%): 10.53/NA

  • Type of general anaesthesia: inhalational anaesthesia (desflurane, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 112.5

  • Use of perioperative opioids (if yes, which?): 26.51 µg sufentanil, 10 mg piritramide

  • Type of surgery: gynaecological, laparoscopic, abdominal


Methylprednisolone
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): NA

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 45.35 ± 15.23

  • Weight (mean ± SD, median (IQR), median (range)): NA

  • BMI (mean ± SD, median (IQR), median (range)): 25.20 ± 20

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): 67.5

  • History of PONV/motion sickness (%): 7.50/NA

  • Type of general anaesthesia: inhalational anaesthesia (desflurane, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 127.5

  • Use of perioperative opioids (if yes, which?): 27.94 µg sufentanil, 10 mg piritramide

  • Type of surgery: gynaecological, laparoscopic, abdominal


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 47.28 ± 16.58

  • Weight (mean ± SD, median (IQR), median (range)): NA

  • BMI (mean ± SD, median (IQR), median (range)): 25.80 ± 7.45

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): 87.5

  • History of PONV/motion sickness (%): 10.00/NA

  • Type of general anaesthesia: inhalational anaesthesia (desflurane, N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 105.0

  • Use of perioperative opioids (if yes, which?): 23.94 µg sufentanil, 10 mg piritramide

  • Type of surgery: gynaecological, laparoscopic, abdominal


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
  • Dose: 8 mg

  • Time point of administration: at induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): alizapride 50 mg or ondansetron 4 mg


Methylprednisolone
  • Dose: 40 mg

  • Time point of administration: at induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): alizapride 50 mg or ondansetron 4 mg


Placebo
  • Dose: normal saline

  • Time point of administration: at induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): alizapride 50 mg or ondansetron 4 mg

Outcomes Vomiting (0 to 2 hours)
  • Outcome type: dichotomous outcome


Vomiting (2 to 24 hours)
  • Outcome type: dichotomous outcome


PONV (0 to 24 hours)
  • Outcome type: dichotomous outcome

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