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

Ganem 2001.

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

  • Enrolled (n): ‐

  • Randomized (n): 27

  • Received treatment (n): NA

  • Analysed (n): 27

  • Age (mean ± SD, median (IQR), median (range)): 35 ± 7

  • Weight (mean ± SD, median (IQR), median (range)): 62 ± 14

  • 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 (%): 0/NA

  • Type of general anaesthesia: TIVA (N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 54

  • Use of perioperative opioids (if yes, which?): sufentanil for induction

  • Type of surgery: diagnostic or surgical gynaecological laparoscopy


Alizapride
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 25

  • Received treatment (n): NA

  • Analysed (n): 25

  • Age (mean ± SD, median (IQR), median (range)): 32 ± 6

  • Weight (mean ± SD, median (IQR), median (range)): 61 ± 10

  • 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 (%): 0/NA

  • Type of general anaesthesia: TIVA (N₂O)

  • Duration of anaesthesia or surgery (in min; as mean or median): 53

  • Use of perioperative opioids (if yes, which?): sufentanil for induction

  • Type of surgery: diagnostic or surgical gynaecological laparoscopy


Included criteria: female, 21 to 50 years of age, ASA I or II, BMI < 30, submitted to diagnostic or surgical gynaecological laparoscopy
Excluded criteria: current or previous gastric complaints, history of nausea and vomiting with previous anaesthesia, movement kinetosis, psychiatric disease, menstruating, alcohol and drug abusers
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
Ondansetron
  • Dose: 4 mg

  • Time point of administration: immediately before anaesthetic induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): Intravenous ondansetron (4 mg)


Alizapride
  • Dose: 50 mg

  • Time point of administration: immediately before anaesthetic induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): Intravenous ondansetron (4 mg)

Outcomes Vomiting (0 to 1 hour, PACU)
  • Outcome type: dichotomous outcome

Identification Sponsorship source: NA
Country: Brazil
Setting: inpatient
Author's name: Eliana Marisa Ganem
Institution: Departamento de Anestesiologiada FMB ‐ UNESP
Email: NA
Address: Deptº de Anestesiologia da FMB ‐ UNESP, Distrito de Rubião Júnior, 18618‐970 ‐ Botucatu, SP
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: "patients were randomly distributed in two groups according to the antiemetic drug, that is, group 1, ondansetron (4 mg) and group 2 alizapride (50 mg)"
Judgement comment: no information on randomization method provided
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: no statement
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 Unclear risk Quote: "groups were homogeneous as to age, weight, height and surgery and anesthesia duration (Table I)"
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