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

Jo 2012.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis and combination prophylaxis
Participants Baseline characteristics
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)): 48 ± 13

  • Weight (mean ± SD, median (IQR), median (range)): 58 ± 9

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 0

  • History of PONV/motion sickness (%): 2.5/12.5

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 67

  • Use of perioperative opioids (if yes, which?): remifentanil intraoperative, 1 µg/kg fentanyl postoperative

  • Type of surgery: laparoscopic cholecystectomy


Dexamethasone (group D)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 44 ± 12

  • Weight (mean ± SD, median (IQR), median (range)): 60 ± 9

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 0

  • History of PONV/motion sickness (%): 0/10

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

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

  • Use of perioperative opioids (if yes, which?): remifentanil intraoperative, 1 µg/kg fentanyl postoperative

  • Type of surgery: laparoscopic cholecystectomy


Ramosetron + dexamethasone (group RD)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 44 ± 10

  • Weight (mean ± SD, median (IQR), median (range)): 58 ± 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 (%): 0

  • History of PONV/motion sickness (%): 0/5

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

  • Duration of anaesthesia or surgery (in min; as mean or median): 71

  • Use of perioperative opioids (if yes, which?): remifentanil intraoperative, 1 µg/kg fentanyl postoperative

  • Type of surgery: laparoscopic cholecystectomy


Included criteria: female, scheduled for elective laparoscopic cholecystectomy under general anaesthesia
Excluded criteria: ASA III or IV; smoking status; antiemetic medication within 24 hours before surgery; administration of steroids within 24 hours before surgery or during the 24 hours after surgery; gastrointestinal, renal, or hepatic disease; insulin‐dependent diabetes mellitus; obesity (body mass index > 35 kg/m²); conversion to open cholecystectomy
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness): no; (perioperative opioids): unclear
Interventions Intervention characteristics
Ramosetron (group R)
  • Dose: 0.3 mg

  • Time point of administration: placebo before induction of anaesthesia, ramosetron approximately 15 minutes before end of surgery

  • Route of administration: IV

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


Dexamethasone (group D)
  • Dose: 8 mg

  • Time point of administration: dexamethasone before induction of anaesthesia, placebo approximately 15 minutes before end of surgery

  • Route of administration: IV

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


Ramosetron + dexamethasone (group RD)
  • Dose: ramosetron 0.3 mg, dexamethasone 8 mg

  • Time point of administration: dexamethasone before induction of anaesthesia, ramosetron approximately 15 minutes before end of surgery

  • Route of administration: IV

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

Outcomes Vomiting (0 to 6 hours)
  • Outcome type: dichotomous outcome


Vomiting (6 to 12 hours)
  • Outcome type: dichotomous outcome


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


Headache (0 to 24 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: Republic of Korea
Setting: inpatient, single‐centre
Author's name: Yong Seon Choi
Institution: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea
Email: yschoi@yuhs.ac
Address: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, 50 Yonsei‐ro, Seodaemun‐gu, Seoul 120‐752, Republic of Korea
Duration of study: NA
Language: English
Study's primary outcome: complete response during 24 hours
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 randomization list"
Allocation concealment (selection bias) Unclear risk Judgement comment: not stated: "sequentially numbered, opaque, and sealed envelopes" (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "the envelopes were opened before anesthetic induction by a physician not involved in the study. The physician then prepared the appropriate study medication"
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Judgement comment: no statement
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "total of 146 patients were assessed for eligibility; 120 of these patients were enrolled in the study and completed surgical procedures (Fig. 1)"
Selective reporting (reporting bias) Unclear risk Judgement comment: no reference to a study protocol or trial registry number reported
Other bias Unclear risk Quote: "patients’ characteristics and operative data were all similar among the three 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): unclear