Skip to main content
. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Paech 2003.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis
Participants Baseline characteristics
Tropisetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 42

  • Received treatment (n): NA

  • Analysed (n): 42

  • Age (mean ± SD, median (IQR), median (range)): 49.4 ± 14.1

  • Weight (mean ± SD, median (IQR), median (range)): 79.3 ± 22.5

  • 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 (%): 42.9/14.3

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 90

  • Use of perioperative opioids (if yes, which?): epidural postoperative infusion with 4 µg/mL fentanyl (140 mL)

  • Type of surgery: major open abdominal gynaecological or gynaecological oncological procedure


Ondansetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 38

  • Received treatment (n): NA

  • Analysed (n): 36

  • Age (mean ± SD, median (IQR), median (range)): 48.3 ± 12.3

  • Weight (mean ± SD, median (IQR), median (range)): 74.6 ± 15.2

  • 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 (%): 30.6/22.2

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 95

  • Use of perioperative opioids (if yes, which?): epidural postoperative infusion with 4 µg/mL fentanyl (143 mL)

  • Type of surgery: major open abdominal gynaecological or gynaecological oncological procedure


Dolasetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): NA

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 48.7 ± 14.4

  • Weight (mean ± SD, median (IQR), median (range)): 74.4 ± 16.8

  • 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 (%): 27.5/20.0

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 92

  • Use of perioperative opioids (if yes, which?): epidural postoperative infusion with 4 µg/mL fentanyl (144 mL)

  • Type of surgery: major open abdominal gynaecological or gynaecological oncological procedure


Included criteria: scheduled for major open abdominal gynaecological or gynaecological oncological procedure
Excluded criteria: experiencing preoperative nausea, receiving medication with antiemetic activity or with contraindications to non‐steroidal anti‐inflammatory medication or epidural anaesthesia, women in whom an open procedure was not performed or who underwent unplanned bowel surgery
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
Tropisetron
  • Dose: 2 mg

  • Time point of administration: at induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM, droperidol 1 mg IV


Ondansetron
  • Dose: 4 mg

  • Time point of administration: at induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM, droperidol 1 mg IV


Dolasetron
  • Dose: 12.5 mg

  • Time point of administration: at end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): prochlorperazine 12.5 mg IM, droperidol 1 mg IV

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


Vomiting (recovery room)
  • Outcome type: dichotomous outcome


Vomiting (18 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: a small proportion of each study drug was supplied free by the respective pharmaceutical companies (Novartis for tropisetron, GlaxoWellcome for ondansetron, Hoechst Marion Roussel for dolasetron)
Country: Australia
Setting: inpatient, single‐centre
Author's name: M. J. Peach
Institution: Department of Anaesthesia and Pain Medicine, King Edward Memorial Hospitalfor Women and Women and Infants Research Foundation, Perth, Western Australia
Email: NA
Address: King Edward Memorial Hospital for Women, 374 Bagot Road, Subiaco, W.A. 6008
Duration of study: NA
Language: English
Study's primary outcome: incidence of vomiting
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Judgement comment: quote: "using a computer‐derived randomisation sequence"
Allocation concealment (selection bias) Unclear risk Judgement comment: quote: "in blinded envelopes"
Not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes High risk Judgement comment: quote: "the study drugs, known only to the attending anaesthetist who took no part in the collection of subsequent data"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Judgement comment: quote: "the study drug, known only to the attending anaesthetist who took no part in the collection of subsequent data"
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: quote: "a total of 120 patients were recruited into the study. Excluded from analysis were two patients from group O, one of whom did not have the procedure and one who was transferred to an intensive care unit postoperatively, precluding data collection"
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