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

Jung 2013.

Study characteristics
Methods Study design: randomized controlled trial
Study grouping: 3 groups, monoprophylaxis, dose‐finding study
Participants Baseline characteristics
Aprepitant (A80 group)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 46 ± 5

  • 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 (%): 38

  • History of PONV/motion sickness (%): 1/3

  • Type of general anaesthesia: inhalational anaesthesia (isoflurane)

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

  • Use of perioperative opioids (if yes, which?): 5 patients received ketorolac 30 mg IV; 2 patients received fentanyl 50 µg IV

  • Type of surgery: laparoscopic total hysterectomy


Aprepitant (A125 group)
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 46 ± 5

  • Weight (mean ± SD, median (IQR), median (range)): 59 ± 7

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

  • ASA I/II/III/IV (n): NA/NA/0/0

  • Gender (female in %): 100

  • Non‐smoker (%): 38

  • History of PONV/motion sickness (%): 1/4

  • Type of general anaesthesia: inhalational anaesthesia (isoflurane)

  • Duration of anaesthesia or surgery (in min; as mean or median): 122

  • Use of perioperative opioids (if yes, which?): 4 patients received ketorolac 30 mg IV; 3 patients received fentanyl 50 µg IV

  • Type of surgery: laparoscopic total hysterectomy


Placebo
  • Assessed for eligibility (n): ‐

  • Enrolled (n): ‐

  • Randomized (n): 40

  • Received treatment (n): 40

  • Analysed (n): 40

  • Age (mean ± SD, median (IQR), median (range)): 46 ± 6

  • Weight (mean ± SD, median (IQR), median (range)): 59 ± 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 (%): 37

  • History of PONV/motion sickness (%): 0/2

  • Type of general anaesthesia: inhalational anaesthesia (isoflurane)

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

  • Use of perioperative opioids (if yes, which?): 4 patients received ketorolac 30 mg IV; 2 patients received fentanyl 50 µg IV

  • Type of surgery: laparoscopic total hysterectomy


Included criteria: ASA I or II, 21 to 60 years of age, scheduled for elective laparoscopic total hysterectomy
Excluded criteria: liver, neurological, and active pulmonary disease; cardiac arrhythmia; allergy to any perioperative medication used in this study
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
Aprepitant (A80 group)
  • Dose: 80 mg

  • Time point of administration: 2 hours before induction

  • Route of administration: PO

  • Rescue antiemetics (if yes, which?): 8% (dexamethasone 5 mg, metoclopramide 10 mg)


Aprepitant (A125 group)
  • Dose: 125 mg

  • Time point of administration: 2 hours before induction

  • Route of administration: PO

  • Rescue antiemetics (if yes, which?): 10% (dexamethasone 5 mg, metoclopramide 10 mg)


Placebo
  • Dose: 10 mL saline

  • Time point of administration: 2 hours before induction

  • Route of administration: PO

  • Rescue antiemetics (if yes, which?): 20% (dexamethasone 5 mg, metoclopramide 10 mg)

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


Vomiting (2 to 24 hours)
  • Outcome type: dichotomous outcome


Headache (0 to 48 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: South Korea
Setting: inpatient, single‐centre
Author's name: Hong Seuk Yang
Institution: Department of Anesthesiology and Pain Medicine, Asan Medical Center, College of Medicine University of Ulsan, South Korea
Email: hsyang@amc.seoul.kr
Address: Department of Anesthesiology and Pain Medicine, Asan Medical Center, College of Medicine University of Ulsan, 388‐1 Pungnap‐dong Songpa‐gu, Seoul 138‐736, South Korea
Duration of study: NA
Language: English
Study's primary outcome: incidence of PONV
Trial registry number: NCT01440673
Notes None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "a randomization list was generated using Microsoft Excel’s random function"
Allocation concealment (selection bias) Unclear risk Judgement comment: no statement
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "to achieve blinding, an independent researcher prepared the study solutions, which consisted of a drinking cup wrapped in foil containing 10 ml saline in the control group and a cup containing dissolved aprepitant tablets in the treatment groups"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "recorded throughout the hospital stay by specially trained personnel blinded to all patient treatments"
Incomplete outcome data (attrition bias)
All outcomes Low risk Judgement comment: no missing outcome data
Selective reporting (reporting bias) Unclear risk Judgement comment: NCT01440673 (retrospective registration)
Other bias Low risk Quote: "the three groups of patients did not differ in characteristics, surgery or anesthesia duration, or and Apfel’s simplified risk score (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