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

Logie 2010.

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

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 73

  • Age (mean ± SD, median (IQR), median (range)): 42.3 ± 14.3

  • Weight (mean ± SD, median (IQR), median (range)): 66 ± 13

  • BMI (mean ± SD, median (IQR), median (range)): 24.8 ± 5.0

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: balanced anaesthesia (sevoflurane, sufentanil)

  • Duration of anaesthesia or surgery (in min; as mean or median): 112

  • Use of perioperative opioids (if yes, which?): intraoperative sufentanil, piritramide as postoperative rescue analgesics

  • Type of surgery: laparoscopic gynaecological surgery


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 53

  • Age (mean ± SD, median (IQR), median (range)): 41.9 ± 14.2

  • Weight (mean ± SD, median (IQR), median (range)): 65 ± 12

  • BMI (mean ± SD, median (IQR), median (range)): 23.5 ± 5.0

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: balanced anaesthesia (sevoflurane, sufentanil)

  • Duration of anaesthesia or surgery (in min; as mean or median): 120

  • Use of perioperative opioids (if yes, which?): intraoperative sufentanil, piritramide as postoperative rescue analgesics

  • Type of surgery: laparoscopic gynaecological surgery


Included criteria: adult women scheduled for elective laparoscopic gynaecological surgery
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Alizapride
  • Dose: 100 mg

  • Time point of administration: 30 minutes before end of the operation

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): first‐line droperidol 1.25 + dexamethasone 5 mg, second‐line ondansetron 4 mg + alizapride 100 mg


Placebo
  • Dose: saline

  • Time point of administration: 30 minutes before end of the operation

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): first‐line droperidol 1.25 + dexamethasone 5 mg, second‐line ondansetron 4 mg + alizapride 100 mg

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

Identification Sponsorship source: NA
Country: Belgium
Setting: NA
Author's name: Nathalie Logie
Institution: NA
Email: NA
Address: NA
Duration of study: NA
Language: English
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: "randomised". 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): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear