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

Yilmazlar 1996.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 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)): 42.5 ± 3.2

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

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 80

  • Non‐smoker (%): NA

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

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

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

  • Use of perioperative opioids (if yes, which?): intraoperative fentanyl 50 µg to 75 µg IV

  • Type of surgery: thyroidectomy


Metoclopramide
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 43.2 ± 4.1

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

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 80

  • Non‐smoker (%): NA

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

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

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

  • Use of perioperative opioids (if yes, which?): intraoperative fentanyl 50 µg to 75 µg IV

  • Type of surgery: thyroidectomy


Tropisetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 20

  • Received treatment (n): NA

  • Analysed (n): 20

  • Age (mean ± SD, median (IQR), median (range)): 41.1 ± 2.8

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

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 85

  • Non‐smoker (%): NA

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

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

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

  • Use of perioperative opioids (if yes, which?): intraoperative fentanyl 50 µg to 75 µg IV

  • Type of surgery: thyroidectomy


Included criteria: ASA I or II, 22 to 60 years of age, scheduled for thyroidectomy with postoperative bed rest of at least 24 hours
Excluded criteria: nausea or emesis in the preoperative period, history of postoperative vomiting after previous anaesthesia, ASA III and IV
Pretreatment: baseline characteristics (age, ASA): no; (weight): unclear. Potential effect modifiers (gender, history of PONV): no; (history of motion sickness, duration of anaesthesia, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Placebo
  • Dose: saline

  • Time point of administration: during anaesthesia induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): not defined


Metoclopramide
  • Dose: 0.2 mg/kg

  • Time point of administration: during anaesthesia induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): not defined


Tropisetron
  • Dose: 5 mg

  • Time point of administration: during anaesthesia induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): not defined

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

Identification Sponsorship source: NA
Country: Turkey
Setting: inpatient, single‐centre
Author's name: A. Yilmazlar
Institution: Department of Anaesthesiology, Uludag University School of Medicine, Bursa, Turkey
Email: NA
Address: Department of Anaesthesiology, Uludag University School of Medicine, Corukle 16059, Bursa, Turkey
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) Unclear risk Quote: "randomized"
Judgement comment: insufficient information about the sequence generation process
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: "double‐blind". No further statement
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: "double‐blind". No further 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 Unclear risk Quote: "Table 1 summarizes the demographic data of the three groups, which were comparable with regard to age and sex. The three groups were not significantly different (P> 0.05). The number of patients vomiting..."
Judgement comment: baseline characteristics (age, ASA): no; (weight): unclear. Potential effect modifiers (gender, history of PONV): no; (history of motion sickness, duration of anaesthesia, non‐smoker, perioperative opioids): unclear