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

Bianchin 2007.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline Characteristics
Dexamethasone (group DESA)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 36

  • Age (mean ± SD, median (IQR), median (range)): 55 (24 to 80)

  • Weight (mean ± SD, median (IQR), median (range)): 69 (51 to 104)

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 69.44

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 0/NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 78

  • Use of perioperative opioids (if yes, which?): fentanyl for anaesthesia up to 3 µg/kg

  • Type of surgery: laparoscopic cholecystectomy


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 37

  • Age (mean ± SD, median (IQR), median (range)): 56 (31 to 80)

  • Weight (mean ± SD, median (IQR), median (range)): 71 (49 to 100)

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 59.46

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 0/NA

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 86

  • Use of perioperative opioids (if yes, which?): fentanyl for anaesthesia up to 3 µg/kg

  • Type of surgery: laparoscopic cholecystectomy


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
Interventions Intervention characteristics
Dexamethasone (group DESA)
  • Dose: 8 mg

  • Time point of administration: 2 minutes before beginning of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV


Placebo
  • Dose: normal saline

  • Time point of administration: 2 minutes before beginning of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV

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


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


Subjects with any SAE (postoperatively)
  • Outcome type: dichotomous outcome


Subjects with any AE (postoperatively)
  • Outcome type: dichotomous outcome


Postoperative wound infection (postoperatively)
  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)
  • Outcome type: general notes on side effects

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
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