Skip to main content
. 2020 Oct 19;2020(10):CD012859. doi: 10.1002/14651858.CD012859.pub2

Bang 2016.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 2 groups, monoprophylaxis
Participants Baseline characteristics
Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 50

  • Received treatment (n): 50

  • Analysed (n): 50

  • Age (mean ± SD, median (IQR), median (range)): 45 ± 11

  • Weight (mean ± SD, median (IQR), median (range)): 59.4 ± 7.9

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

  • ASA I/II/III/IV (n): 38/12/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 92

  • History of PONV/motion sickness (%): 50/92

  • Type of general anaesthesia: TIVA

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

  • Use of perioperative opioids (if yes, which?): 536.8 µg fentanyl

  • Type of surgery: gynaecological laparoscopic surgery


Palonosetron
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 50

  • Received treatment (n): 50

  • Analysed (n): 50

  • Age (mean ± SD, median (IQR), median (range)): 43 ± 8

  • Weight (mean ± SD, median (IQR), median (range)): 59.8 ± 7.1

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

  • ASA I/II/III/IV (n): 38/12/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 86

  • History of PONV/motion sickness (%): 56/86

  • Type of general anaesthesia: TIVA

  • Duration of anaesthesia or surgery (in min; as mean or median): 126

  • Use of perioperative opioids (if yes, which?): 540.9 µg fentanyl

  • Type of surgery: gynaecological laparoscopic surgery


Included criteria: women 20 to 60 years of age with American Society of Anesthesiologists physical status I or II
Excluded criteria: patients who experienced vomiting or retching in the 24‐hour period before surgery; patients who underwent emetogenic radiotherapy within 8 weeks or cancer chemotherapy within 4 weeks before study entry; patients who had received steroids, antiemetics, or psychoactive medications 24 hours before study initiation
Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no
Interventions Intervention characteristics
Placebo
  • Dose: saline 1.5 mL

  • Time point of administration: just before induction of anaesthesia

  • Route of administration: IV

  • Rescue antiemetics (if yes, which?): 12% (metoclopramide 10 mg)


Palonosetron
  • Dose: 0.075 mg

  • Time point of administration: just before induction of anaesthesia

  • Route of administration: IV

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

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


Vomiting (0 to 2 hours)
  • Outcome type: dichotomous outcome


Vomiting (2 to 6 hours)
  • Outcome type: dichotomous outcome


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


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


Subjects with any SAE (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: there are no financial or other relationships to disclose that might lead to a conflict of interest regarding this article
Country: Korea
Setting: inpatient, single‐centre
Author's name: Soo Kyoung Park
Institution: Department of Anesthesiology and Pain Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Gyeonggi, Korea
Email: hardmong@naver.com
Address: Department of Anesthesiology and Pain Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7 Keun Jaebong Road, Hwaseong, Gyeonggi, Korea
Duration of study: June to October 2015
Language: English
Study's primary outcome: the primary outcome was the overall incidence of nausea and vomiting during the first 24 hours after anaesthesia
Trial registry number: NCT01478165
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "using a computer‐generated number table"
Allocation concealment (selection bias) Unclear risk Quote: "trained nurses, who were not involved in the study, prepared the study drugs before induction of anesthesia, according to directions in an envelope containing the allocation groups"
Judgement comment: not stated sequentially numbered, opaque, and sealed envelopes (SNOSE)
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "trained nurses, who were not involved in the study, prepared the study drugs before induction of anesthesia, according to directions in an envelope containing the allocation groups"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "every assessment and interview was performed by doctors blinded to treatment group enrolment"
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "one hundred patients were enrolled (50 per group) and all completed the study"
Selective reporting (reporting bias) Unclear risk Judgement comment: NCT01478165 (retrospective registration)
Other bias Low risk Quote: "patient demographic data, risk factors and operative data were comparable 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, perioperative opioids): no