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

McKenzie 1997.

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

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range), mean (CI low, high)): 40 (37.0 to 42.3)

  • Weight (mean ± SD, median (IQR), median (range)): 67 (62.7 to 71.5)

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

  • ASA I/II/III/IV (n): NA/NA/NA/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 50/25

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 107

  • Use of perioperative opioids (if yes, which?): 393 µg fentanyl, 47 mg morphine via PCA in 24 hours

  • Type of surgery: major gynaecological surgery


Ondansetron + dexamethasone
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range), mean (CI low, high)): 41 (38.5 to 43.8)

  • Weight (mean ± SD, median (IQR), median (range)): 70 (66.5 to 73.9)

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

  • ASA I/II/III/IV (n): NA/NA/NA/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 50/36

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 100

  • Use of perioperative opioids (if yes, which?): 436 µg fentanyl, 50 mg morphine via PCA in 24 hours

  • Type of surgery: major gynaecological surgery


Included criteria: after approval of the Magee‐Women's Hospital Institutional Review Board, informed consent was obtained from 80 women 18 to 65 years of age, who were scheduled for major gynaecological surgery. All women were ASA I, II, or III
Excluded criteria: diabetes; had recently (within 24 hours) ingested any other medicine with potential antiemetic properties; had hypersensitivity to soybean, ondansetron, or corticoids; if continuous gastric suction was ordered during the 24‐hour postoperative period
Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear
Interventions Intervention characteristics
Ondansetron
  • Dose: 4 mg

  • Time point of administration: ondansetron with saline after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 57.5% (droperidol 0.625 mg IV, prochlorperazine IM)


Ondansetron + dexamethasone
  • Dose: ondansetron 4 mg, dexamethasone 20 mg

  • Time point of administration: after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 47,5% (droperidol 0.625 mg IV, prochlorperazine IM)

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


Vomiting (0 to 2 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: US
Setting: inpatient, single‐centre
Author's name: Ray McKenzie
Institution: Department of Anesthesiology, Magee‐Womens Hospital, Pittsburgh, PA, USA
Email: NA
Address: 300 Halket Street, Pittsburgh, PA 15213, USA
Language: English
Duration of study: NA
Trial registry number: NA
Study's primary outcome: complete response, defined as no emesis and no administration of rescue antiemetic medication during the 24‐hour postoperative period
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "...each ml of blood lost. The patients were stratified by a positive or negative history of PONV with previous surgery to assure an equal number of patients (n = 20) in each subgroup. After induction of anesthesia and when the patient was stable, ondansetron 4 mg IV was given. Identical syringes of saline (Group 1) or dexamethasone 20 mg (Group 2) were prepared via random number table assignment by personnel not involved in the study. The unknown study drug was administered..."
Allocation concealment (selection bias) Low risk Quote: "...4 mg IV was given. Identical syringes of saline (Group 1) or dexamethasone 20 mg (Group 2) were prepared via random number table assignment by personnel not involved in the study. The unknown study drug was administered IV..."
Judgement comment: participants and investigators could not foresee assignment (random number table and syringes generated by personnel not involved in the study)
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "after induction of anesthesia and when the patient was stable, ondansetron 4 mg IV was given. Identical syringes of saline (Group 1) or dexamethasone 20 mg (Group 2) were prepared via random number table assignment by personnel not involved in the study. The unknown study drug was administered IV after confirming no change in vital signs. The 24hour study duration began..."
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement on blinding of outcome assessors
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, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear