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

Argiriadou 2002.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis
Participants Baseline characteristics
Ondansetron (group A)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 29

  • Received treatment (n): 29

  • Analysed (n): 29

  • Age (mean ± SD, median (IQR), median (range)): 43.9 ± 13.6

  • Weight (mean ± SD, median (IQR), median (range)): 71.5 ± 14.6

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

  • ASA I/II/III/IV (n): 21/8/0/0

  • Gender (female in %): 79.31

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 0

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 67.4

  • Use of perioperative opioids (if yes, which?): 3 to 5 µg/kg fentanyl at induction, dextropropoxyphene or meperidine as rescue analgesic

  • Type of surgery: laparoscopic cholecystectomy


Tropisetron (group B)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 31

  • Received treatment (n): 31

  • Analysed (n): 31

  • Age (mean ± SD, median (IQR), median (range)): 47.9 ± 16.7

  • Weight (mean ± SD, median (IQR), median (range)): 73.4 ± 13

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

  • ASA I/II/III/IV (n): 19/12/0/0

  • Gender (female in %): 74.19

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 0

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 75

  • Use of perioperative opioids (if yes, which?): 3 to 5 µg/kg fentanyl at induction, dextropropoxyphene or meperidine as rescue analgesic

  • Type of surgery: laparoscopic cholecystectomy


Placebo (group C)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 27

  • Received treatment (n): 27

  • Analysed (n): 27

  • Age (mean ± SD, median (IQR), median (range)): 41.3 ± 13.6

  • Weight (mean ± SD, median (IQR), median (range)): 68.5 ± 8.3

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

  • ASA I/II/III/IV (n): 17/10/0/0

  • Gender (female in %): 74.07

  • Non‐smoker (%): NA

  • History of PONV/motion sickness (%): 0

  • Type of general anaesthesia: inhalational anaesthesia (sevoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 69

  • Use of perioperative opioids (if yes, which?): 3 to 5 µg/kg fentanyl at induction, dextropropoxyphene or meperidine as rescue analgesic

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: ASA I and II patients scheduled for elective laparoscopic cholecystectomy
Excluded criteria: patients who had a history of PONV, motion sickness, gastrointestinal disorders, or receipt of antiemetic within 24 hours before surgery
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness): no; (non‐smoker, perioperative opioids): unclear
Interventions Intervention characteristics
Ondansetron (group A)

  • Dose: 4 mg

  • Time point of administration: at anaesthesia induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 24.1% (metoclopramide 10 mg IV)


Tropisetron (group B)

  • Dose: 5 mg

  • Time point of administration: at anaesthesia induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 16.1% (metoclopramide 10 mg IV)


Placebo (group C)

  • Dose: saline

  • Time point of administration: at anaesthesia induction

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): metoclopramide 10 mg IV
Outcomes Headache (0 to 12 hours)

  • Outcome type: dichotomous outcome


Sedation/ drowsiness (0 to 12 hours)

  • Outcome type: dichotomous outcome
Identification Sponsorship source: NA
Country: Greece
Setting: inpatient, single‐centre
Author's name: B. Papaziogas
Institution: 2nd Surgical Clinic of the Aristotle University of Thessaloniki, G. Gennimatas Hospital, Ethnikis Aminis 41, 546 35 Thessaloniki, Greece
Email: NA
Address: Bl. Gabriilidis str. 29, 546 55 Thessaloniki, Greece
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) Low risk Quote: "using a computer‐generated randomized list"
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "the syringes containing each drug were identical and were prepared by personnel not involved in the study"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "these parameters were measured immediately after surgery (0 h), and at 3 h, 6 h, and 12 h postoperatively by anesthesia residents blinded to which antiemetic the patient had received"
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 Quote: "were enrolled in the study. Patients' demographics were similar in all study groups (Table 1). Both groups A"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness): no; (non‐smoker, perioperative opioids): unclear