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

Kim JE 2005.

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

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 40 ± 11.5

  • Weight (mean ± SD, median (IQR), median (range)): 59 ± 6.4

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

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

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

  • Use of perioperative opioids (if yes, which?): none

  • Type of surgery: breast tumour resection


Granisetron (group G)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 43 ± 12.2

  • Weight (mean ± SD, median (IQR), median (range)): 60 ± 5.4

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 82

  • Use of perioperative opioids (if yes, which?): none

  • Type of surgery: breast tumour resection


Ramosetron (group R)

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 41 ± 13.3

  • Weight (mean ± SD, median (IQR), median (range)): 59 ± 5.6

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 79

  • Use of perioperative opioids (if yes, which?): none

  • Type of surgery: breast tumour resection


Included criteria: healthy female patients with ASA body class I or II who underwent general anaesthesia for breast tumour resection
Excluded criteria: cardiovascular, respiratory, brain disease; kidney or liver abnormalities; gastritis, stomach ulcers, etc.; intestinal disease or frequent nausea; severe obesity; pregnancy; history of PONV; had received intravenous antibiotics within 24 hours before surgery
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV, perioperative opioids): no; (history of motion sickness, non‐smoker): unclear
Interventions Intervention characteristics
Placebo (group P)

  • Dose: saline

  • Time point of administration: at end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): (22.5%) metoclopramide 10 mg


Granisetron (group G)

  • Dose: 40 g/kg

  • Time point of administration: at end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): (2.5%) metoclopramide 10 mg


Ramosetron (group R)

  • Dose: 6 µg/kg

  • Time point of administration: at end of surgery

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): (0%) metoclopramide 10 mg
Outcomes Vomiting (0 to 6 hours)

  • Outcome type: dichotomous outcome


Vomiting (6 to 24 hours)

  • Outcome type: dichotomous outcome


Headache (0 to 48 hours)

  • Outcome type: dichotomous outcome


Constipation (0 to 48 hours)

  • Outcome type: dichotomous outcome


Sedation/drowsiness (0 to 48 hours)

  • Outcome type: dichotomous outcome
Identification Sponsorship source: NA
Country: Korea
Setting: inpatient, single‐centre
Author's name: Oxy‐Young
Institution: Department of Anesthesiology and Pain Medicine, Soonchunhyang University Hospital
Email: syok2377@hanmail.net
Address: Department of Anesthesiology and Pain Medicine, Soonchunhyang University Hospital, 657 Hannam‐dong, Yongsan‐gu, Seoul, Korea
Duration of study: NA
Language: Korean (Google Translator)
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 Judgement comment: quote: "randomized". 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 Judgement comment: anaesthesiologists unaware of group allocation administered the drugs
Blinding of outcome assessment (detection bias)
All outcomes Low risk Judgement comment: anaesthesiologists unaware of group allocation performed outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: quote: "among the 145 patients who underwent breast tumor resection, 15 patients had gastrointestinal diseases such as gastritis and gastric ulcer, 7 patients had frequent nausea, 2 patients had severe obesity, patients with a history of PONV (1 patient) were excluded from the study (total 25 patients) and 120 patients were enrolled". Reasons for exclusions reported
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, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV, perioperative opioids): no; (history of motion sickness, non‐smoker): unclear