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

Lee 2012.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis and combination prophylaxis
Participants Baseline characteristics
Ramosetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 42

  • Received treatment (n): NA

  • Analysed (n): 42

  • Age (mean ± SD, median (IQR), median (range)): 43.6 ± 10.4

  • Weight (mean ± SD, median (IQR), median (range)): 61.3 ± 12.1

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 92.86

  • History of PONV/motion sickness (%): 7.14/ 19.05

  • Type of general anaesthesia: balanced anaesthesia (desflurane, remifentanil)

  • Duration of anaesthesia or surgery (in min; as mean or median): 158.8

  • Use of perioperative opioids (if yes, which?): 247.2 mg remifentanil intraoperative, postoperative fentanyl via PCA

  • Type of surgery: gynaecological


Aprepitant + ramosetron

  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 42

  • Received treatment (n): NA

  • Analysed (n): 42

  • Age (mean ± SD, median (IQR), median (range)): 43.8 ± 8.2

  • Weight (mean ± SD, median (IQR), median (range)): 61.2 ± 8.8

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 95.24

  • History of PONV/motion sickness (%): 4.76/14.29

  • Type of general anaesthesia: balanced anaesthesia (desflurane, remifentanil)

  • Duration of anaesthesia or surgery (in min; as mean or median): 145.0 ± 62

  • Use of perioperative opioids (if yes, which?): 332.79 mg remifentanil intraoperative, postoperative fentanyl via PCA

  • Type of surgery: gynaecological


Included criteria: women between 20 and 70 years of age, ASA I or II, scheduled to undergo gynaecological surgery with general anaesthesia and received IV PCA
Excluded criteria: refusal to participate in the research, history of drug abuse, hypersensitivity reaction, nausea, received antiemetics before surgery within 24 hours, pregnancy, breastfeeding, cancer, inadequate participation in clinical trials for other reasons
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness): no; (perioperative opioids): yes
Interventions Intervention characteristics
Ramosetron

  • Dose: 0.3 mg

  • Time point of administration: after induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 10 mg metoclopramide, 4 mg ondansetron additionally


Aprepitant + ramosetron

  • Dose: aprepitant 80 mg, ramosetron 0.3 mg

  • Time point of administration: aprepitant 2 to 3 hours before induction of anaesthesia, ramosetron after induction of anaesthesia

  • Route of administration: aprepitant PO, ramosetron IV

  • Rescue antiemetics (if yes, which?): 10 mg metoclopramide, 4 mg ondansetron additionally
Outcomes Vomiting (0 to 24 hours)

  • Outcome type: dichotomous outcome


Vomiting (0 to 6 hours)

  • Outcome type: dichotomous outcome


Vomiting (6 to 24 hours)

  • Outcome type: dichotomous outcome


Nausea (0 to 24 hours)

  • Outcome type: dichotomous outcome


Headache (0 to 24 hours)

  • Outcome type: dichotomous outcome


Sedation/drowsiness (0 to 24 hours)

  • Outcome type: dichotomous outcome
Identification Sponsorship source: NA
Country: Korea
Setting: inpatient, single‐centre
Author's name: Soon Im Kim
Institution: Department of Anesthesiology and Pain Medicine, Soonchunhyang University Seoul Hospital, Seoul, Korea
Email: soonnim@schmc.ac.kr
Address: Department of Anesthesiology and Pain Medicine, Soonchunhyang University Seoul Hospital, 22, Daesagwan‐gil, Yongsan‐gu, Seoul 140‐887, Korea. Tel: 82‐2‐705‐9294, Fax: 82‐2‐790‐0394
Duration of study: 10 April to 30 November 2011
Language: English
Study's primary outcome: PONV incidence
Trial registry number: NA
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "according to computer‐based random number generation, patients were divided into an aprepitant group (n = 42) and a control group (n = 42)"
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes High risk Judgement comment: open‐label trial; no placebo intervention in the control group
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "in the recovery room, the anesthesiologist visited with each patient, being blinded to the conditions"
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 High risk Quote: "the patient's age, weight, surgery time, anesthesia time, past history of nausea, past history of PONV, smoking and amount of usage of remifentanil was recorded. There was no statistically significant difference between the two groups (Table 1)"
Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness): no; (perioperative opioids): yes