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

Chen 1996.

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

  • Enrolled (n): ‐

  • Randomized (n): 25

  • Received treatment (n): 25

  • Analysed (n): 24

  • Age (mean ± SD, median (IQR), median (range)): 40.1 ± 8.8

  • Weight (mean ± SD, median (IQR), median (range)): 55.7 ± 8.0

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 21/30

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 106.0

  • Use of perioperative opioids (if yes, which?): 17.4 mg methadone, 11 pethidine

  • Type of surgery: abdominal hysterectomy or ovarian surgery


Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 25

  • Received treatment (n): 25

  • Analysed (n): 25

  • Age (mean ± SD, median (IQR), median (range)): 39.7 ± 9.0

  • Weight (mean ± SD, median (IQR), median (range)): 56.2 ± 7.4

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

  • ASA I/II/III/IV (n): NA

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 12/20

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 112.7

  • Use of perioperative opioids (if yes, which?): 19 mg methadone, 17 pethidine

  • Type of surgery: abdominal hysterectomy or ovarian surgery


Included criteria: ASA I or II, 18 to 60 years of age, scheduled for abdominal hysterectomy or ovarian surgery
Excluded criteria: preexisting nausea or vomiting, antiemetics or opioids given in the 24 hours before surgery, pregnancy, gastro‐oesophageal reflux, alcohol or drug abuse
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear
Interventions Intervention characteristics
Metoclopramide
  • Dose: 10 mg

  • Time point of administration: end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 42% (prochlorperazine 12.5 mg IM)


Ondansetron
  • Dose: 4 mg

  • Time point of administration: end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 36% (prochlorperazine 12.5 mg IM)

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


Vomiting (0 to 4 hours)
  • Outcome type: dichotomous outcome


Vomiting (12 to 24 hours)
  • Outcome type: dichotomous outcome


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


Complete response (no PONV) in 24 hours
  • Outcome type: dichotomous outcome


Adverse events (general notes in the publication, 24 hours' observation)
  • Outcome type: general notes on side effects

Identification Sponsorship source: NA
Country: China
Setting: inpatient, single‐centre
Author's name: P.P. Chen
Institution: Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT, Hong Kong
Email: NA
Address: NA
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: incidence of PONV
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Judgement comment: quote: "allocated randomly to receive either ondasetron 4 mg or metoclopramide 10 mg using a series of sealed envelopes"
Insufficient information on the sequence generation process
Allocation concealment (selection bias) Unclear risk Judgement comment: quote: "allocated randomly to receive either ondasetron 4 mg or metoclopramide 10 mg using a series of sealed envelopes"
Detailed information on envelopes is missing (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: quote: "double‐blinded"
Insufficient information on blinding
Blinding of outcome assessment (detection bias)
All outcomes Low risk Judgement comment: quote: "sedation, nausea and vomiting were assessed by an investigator blinded to the study drug"
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: quote: "twenty‐five patients were initially recruited into each Group. One Patient in the metoclopramide group was excluded after she developed post‐operative respiratory depression"
Reasons for missing data from 1 patient were described and are unlikely related to outcomes of interest
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, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear