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

Jokela 2002.

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

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 60

  • Age (mean ± SD, median (IQR), median (range)): 51 ± 13

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

  • BMI (mean ± SD, median (IQR), median (range)): 26 ± 5

  • ASA I/II/III/IV (n): 45/48/7/0

  • Gender (female in %): 100

  • Non‐smoker (%): 80

  • History of PONV/motion sickness (%): 71.6/33.3

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 123

  • Use of perioperative opioids (if yes, which?): 6.0 µg/kg fentanyl intraoperative, 0.33 mg/kg oxycodone postoperative

  • Type of surgery: thyroid or parathyroid surgery


Tropisetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 60

  • Age (mean ± SD, median (IQR), median (range)): 49 ± 14

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

  • BMI (mean ± SD, median (IQR), median (range)): 26 ± 5

  • ASA I/II/III/IV (n): 52/38/10/0

  • Gender (female in %): 100

  • Non‐smoker (%): 66.6

  • History of PONV/motion sickness (%): 76.6/30

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 108

  • Use of perioperative opioids (if yes, which?): 5.3 µg/kg fentanyl intraoperative, 0.35 mg/kg oxycodone postoperative

  • Type of surgery: thyroid or parathyroid surgery


Metoclopramide
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): NA

  • Received treatment (n): NA

  • Analysed (n): 59

  • Age (mean ± SD, median (IQR), median (range)): 47 ± 13

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

  • BMI (mean ± SD, median (IQR), median (range)): 26 ± 5

  • ASA I/II/III/IV (n): 64/31/5/0

  • Gender (female in %): 100

  • Non‐smoker (%): 84.7

  • History of PONV/motion sickness (%): 71.1/49.1

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane, fentanyl)

  • Duration of anaesthesia or surgery (in min; as mean or median): 111

  • Use of perioperative opioids (if yes, which?): 5.9 µg/kg fentanyl intraoperative, 0.34 mg/kg oxycodone postoperative

  • Type of surgery: thyroid or parathyroid surgery


Included criteria: adult, ASA I to III, female, scheduled for thyroid or parathyroid surgery
Excluded criteria: NA
Pretreatment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no
Interventions Intervention characteristics
Ondansetron
  • Dose: 16 mg

  • Time point of administration: 1 hour before the operation

  • Route of administration: PO

  • Rescue antiemetics (if yes, which?): (64%) droperidol 0.75 mg IV


Tropisetron
  • Dose: 5 mg

  • Time point of administration: 1 hour before the operation

  • Route of administration: PO

  • Rescue antiemetics (if yes, which?): (50%) droperidol 0.75 mg IV


Metoclopramide
  • Dose: 10 mg

  • Time point of administration: 1 hour before the operation

  • Route of administration: PO

  • Rescue antiemetics (if yes, which?): (71%) droperidol 0.75 mg IV

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


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


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


Visual disturbances (e.g. blurred vision) (0 to 24 hours)
  • Outcome type: dichotomous outcome

Identification Sponsorship source: NA
Country: Finland
Setting: inpatient, multi‐centre (3)
Author's name: Ritva Jokela
Institution: Department of Anaesthesia and Intensive Care, Helsinki University
Email: ritva.m.jokela@hus.fi
Address: Department of Anaesthesia and Intensive Care, Helsinki University, PB 140 (Haartmaninkatu 2), FIN‐00029 HUCH, Finland
Duration of study: NA
Language: English
Study's primary outcome: PONV
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "the patients were randomly assigned (sealed envelope technique)"
Judgement comment: no further information on sequence generation provided
Allocation concealment (selection bias) Unclear risk Judgement comment: stated: "sequentially numbered, opaque, and sealed envelopes" (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Judgement comment: no statement
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Quote: "a study nurse or one of the investigators interviewed the patients after 2 hours in the PACU and after 24 hours on the ward"
Judgement comment: no statement on blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "we enrolled 200 patients in the study. Six patients were excluded as a result of a reoperation during the study period and 15 patients because of protocol violations. In the final analysis we had 179 patients: 60 in the ondansetron (Group O) and tropisetron (Group T) groups, and 59 in the metoclopramide (Group M) group. One hundred and sixteen patients were studied at Oulu University Hospital, 37 at Lapland Central Hospital, and 26 at Kuopio University Hospital"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Low risk Judgement comment: baseline characteristics (age, BMI, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no