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

Purhonen 1997.

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): 50

  • Received treatment (n): NA

  • Analysed (n): 48

  • Age (mean ± SD, median (IQR), median (range)): 51 ± 1

  • Weight (mean ± SD, median (IQR), median (range)): 73 ± 2

  • 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 (%): 43.8/29.6

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 149

  • Use of perioperative opioids (if yes, which?): fentanyl 1 µg/kg just before incision and every 30 minutes thereafter for anaesthesia, 73 mg oxycodone

  • Type of surgery: gynaecological incontinence operation


Droperidol

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 50

  • Received treatment (n): NA

  • Analysed (n): 49

  • Age (mean ± SD, median (IQR), median (range)): 50 ± 1

  • Weight (mean ± SD, median (IQR), median (range)): 70 ± 2

  • 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 (%): 57.1/41.3

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 144

  • Use of perioperative opioids (if yes, which?): fentanyl 1 µg/kg just before incision and every 30 minutes thereafter for anaesthesia, 66 mg oxycodone

  • Type of surgery: gynaecological incontinence operation


Placebo

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 50

  • Received treatment (n): NA

  • Analysed (n): 49

  • Age (mean ± SD, median (IQR), median (range)): 50 ± 1

  • Weight (mean ± SD, median (IQR), median (range)): 71 ± 2

  • 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 (%): 65.3/42.2

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 145

  • Use of perioperative opioids (if yes, which?): fentanyl 1 µg/kg just before incision and every 30 minutes thereafter for anaesthesia, 73 mg oxycodone

  • Type of surgery: gynaecological incontinence operation


Included criteria: female inpatients, ASA I to III, scheduled to undergo elective gynaecological incontinence operation under general anaesthesia
Excluded criteria: had experienced nausea or vomiting 24 hours before the study, taking antiemetic medication
Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids, history of motion sickness): no; (non‐smoker): unclear; (history of PONV): yes
Interventions Intervention characteristics
Tropisetron

  • Dose: 5 mg

  • Time point of administration: within 15 minutes of the end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 43.75% (metoclopramide 10 mg IV, tropisetron 5 mg IV)


Droperidol

  • Dose: 1.25 mg

  • Time point of administration: within 15 minutes of the end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 51.02% (metoclopramide 10 mg IV, droperidol 1.25 mg IV)


Placebo

  • Dose: 0.9% saline

  • Time point of administration: within 15 minutes of the end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 69.39% (metoclopramide 10 mg IV)
Outcomes Extrapyramidal symptoms (tremor, 0 to 48 hours)

  • Outcome type: dichotomous outcome


Headache (0 to 48 hours)

  • Outcome type: dichotomous outcome


Visual disturbances (e.g. blurred vision) (0 to 48 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: Finland
Setting: inpatient, single‐centre
Author's name: Sinikka Purhonen
Institution: Departments of Anesthesiology and Gynecology, University Hospital of Kuopio, Kuopio, Finland
Email: NA
Address: Department of Anesthesiology, Kuopio University Hospital, PL 1777, FIN‐70211 Kuopio, Finland
Duration of study: NA
Language: English
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 Quote: "patients were prospectively randomized to receive..."
Judgement comment: 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 Low risk Quote: "...at this small dose (10). The test infusions were prepared by a nurse who did not take part in the study and were thus, blinded for the personnel performing the study. We used oxycodone (0.12 mg/kg..."
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "these nurses, blinded to the study group, performed continuous observation of the patients in the recovery room. On the ward, they observed the patients at various intervals according to their normal ward routine"
Incomplete outcome data (attrition bias)
All outcomes High risk Quote: "...receiving tropisetron were excluded because of missing data. One patient in the droperidol group and one in the placebo group discontinued the study because of profuse vomiting on the ward, and they were excluded due to their refusal to continue the study. The treatment groups were similar"
Judgement comment: exclusion due to profuse vomiting. Missing data 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 High risk Quote: "...refusal to continue the study. The treatment groups were similar, except for the patients’ height (Table 1). More than a half of the patients had a history of previous PONV with equal frequency among the groups. They experienced more nausea and vomiting"
Judgement comment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids, history of motion sickness): no; (non‐smoker): unclear; (history of PONV): yes