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

Stefani 1995.

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

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 56.3 ± 12.03

  • Weight (mean ± SD, median (IQR), median (range)): 72.8 ± 14.66

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 68.5

  • Use of perioperative opioids (if yes, which?): 1.5 µg/kg fentanyl at induction, ketorolac for postoperative analgesia

  • Type of surgery: laparoscopic cholecystectomy


Tropisetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 50.55 ± 10.31

  • Weight (mean ± SD, median (IQR), median (range)): 68.95 ± 10.09

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 67.55

  • Use of perioperative opioids (if yes, which?): 1.5 µg/kg fentanyl at induction, ketorolac for postoperative analgesia

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: female, ASA I or II
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear
Interventions Intervention characteristics
Placebo
  • Dose: saline

  • Time point of administration: 15 minutes before end of surgery

  • Route of administration: IV

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


Tropisetron
  • Dose: 5 mg

  • Time point of administration: 15 minutes before end of surgery

  • 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

Identification Sponsorship source: NA
Country: Italy
Setting: inpatient, single‐centre
Author's name: M. Stefani
Institution: Servizi di Anestesia e Terapia del Dolore, Ospedale Regina Apostolorum Alabano Laziale, Roma
Email: NA
Address: NA
Duration of study: NA
Language: Italian (translated by Insa Backhaus)
Study's primary outcome: NA
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Judgement comment: quote: "with a randomized double‐blind system, the patients were randomly assigned to two groups of 20 people" (translated). No further information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding ("double‐blind")
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: insufficient information on blinding ("double‐blind")
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 Unclear risk Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear