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

Badaoui 1999.

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): NA

  • Received treatment (n): NA

  • Analysed (n): 50

  • Age (mean ± SD, median (IQR), median (range)): 51 ± 19

  • Weight (mean ± SD, median (IQR), median (range)): 72 ± 17

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

  • ASA I/II/III/IV (n): 30/15/5/0

  • Gender (female in %): 56

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: balanced anaesthesia (isoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 62

  • Use of perioperative opioids (if yes, which?): intraoperative fentanyl 0.1 mg bolus as required

  • Type of surgery: cholecystectomy, parotid, proctologic surgery, thyroidectomy, mastectomy, varicosectomy


Droperidol
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 50

  • Age (mean ± SD, median (IQR), median (range)): 49 ± 16

  • Weight (mean ± SD, median (IQR), median (range)): 76.5 ± 16

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

  • ASA I/II/III/IV (n): 26/20/3/1

  • Gender (female in %): 50

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: balanced anaesthesia (isoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 66

  • Use of perioperative opioids (if yes, which?): intraoperative fentanyl 0.1 mg bolus as required

  • Type of surgery: cholecystectomy, parotid, proctologic surgery, thyroidectomy, mastectomy, varicosectomy


Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 45

  • Age (mean ± SD, median (IQR), median (range)): 52 ± 15

  • Weight (mean ± SD, median (IQR), median (range)): 75 ± 17

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

  • ASA I/II/III/IV (n): 27/16/2/0

  • Gender (female in %): 53.3

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: balanced anaesthesia (isoflurane, N₂O, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 61

  • Use of perioperative opioids (if yes, which?): intraoperative fentanyl 0.1 mg bolus as required

  • Type of surgery: cholecystectomy, parotid surgery, proctologic surgery, thyroidectomy, mastectomy, varicosectomy


Included criteria: age over 18 years, elective surgery that "was considered emetogenic", ASA I to III
Excluded criteria: NA
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Placebo
  • Dose: 125 ml NaCl

  • Time point of administration: 30 minutes before anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Droperidol
  • Dose: 1 mg

  • Time point of administration: 30 minutes before anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA


Ondansetron
  • Dose: 4 mg

  • Time point of administration: 30 minutes before anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): NA

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


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

Identification Sponsorship source: NA
Country: France
Setting: inpatient, single‐centre
Author's name: D.R. Badaoui
Institution: Department of Anesthesia Resuscitation B, Chu Nord
Email: NA
Address: Départment d'Anesthésie‐Réanimation B, CHU Nord, place Victor‐Pauchet, 80054 Amiens Cedex 01
Duration of study: February to July 1997
Language: French (2 reviewers: MSS, AA)
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: "randomized" (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: quote: "double‐blind" (translated)
Insufficient information on blinding
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: quote: "double‐blind" (translated)
Insufficient information on blinding
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Judgement comment: it is stated that 150 participants have been included and 145 CRFs were analysable. No reasons/further information for exclusion of the 5 participants, which apparently have been all in the ondansetron arm, are provided
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): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids): unclear