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

NCT00888329.

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

  • Enrolled (n): NA

  • Randomized (n): 125

  • Received treatment (n): NA

  • Analysed (n): 35/34 (efficacy/safety)

  • Age (mean ± SD, median (IQR), median (range)): 60 (12)

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

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

  • ASA I/II/III/IV (n): NA/NA/NA/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: standardized anaesthesia

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

  • Use of perioperative opioids (if yes, which?): NA

  • Type of surgery: hysterectomy


Placebo
  • Assessed for eligibility (n): NA

  • Enrolled (n): NA

  • Randomized (n): 131

  • Received treatment (n): NA

  • Analysed (n): 59/37 (efficacy/safety)

  • Age (mean ± SD, median (IQR), median (range)): 53 (12)

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

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

  • ASA I/II/III/IV (n): NA/NA/NA/0

  • Gender (female in %): 100

  • Non‐smoker (%): NA

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

  • Type of general anaesthesia: standardized anaesthesia

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

  • Use of perioperative opioids (if yes, which?): NA

  • Type of surgery: hysterectomy


Included criteria: scheduled for elective hysterectomy at Mayo Clinic in Arizona; ASA I, II, or III
Excluded criteria: pregnancy; concomitant bowel surgery other than appendectomy; hypersensitivity to study drug or rescue medication; preoperative score for nausea > 4 out of 10 points; severe hepatic insufficiency (Child‐Pugh score > 9); any condition that impairs the patient's ability to complete study assessments; intraoperative haemodynamic instability; ICU admission; prolonged postoperative intubation; rifampin, carbamazepine, phenytoin, or other drugs that strongly induce CYP3A4 activity; other antiemetic within 12 hours before surgery; participation in a clinical trial using an investigational product
Pretreatment: baseline characteristics (age): no; (weight, ASA): unclear. Potential effect modifiers (gender): no; (history of PONV/motion sickness, non‐smoker, perioperative opioids, duration of surgery): unclear
Interventions Intervention characteristics
Aprepitant
  • Dose: 40 mg

  • Time point of administration: before anaesthesia induction

  • Route of administration: PO

  • Rescue antiemetics (if yes, which?): NA


Placebo
  • Dose: NA

  • Time point of administration: NA

  • Route of administration: NA

  • Rescue antiemetics (if yes, which?): NA

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

Identification Sponsorship source: Mayo Clinic
Country: USA
Setting: inpatient/outpatient, single‐centre
Author's name: Javier Magrina
Institution: Mayo Clinic, Phoenix, Arizona, United States, 85054, USA
Email: magrina.javier@mayo.edu
Address: Mayo Clinic, Phoenix, Arizona, United States, 85054, USA
Duration of study: July 2007 to October 2011
Language: English
Study's primary outcome: number of patients with emesis within 24 hours
Trial registry number: NCT00888329
Notes Results posted only on ClinicalTials.gov (study terminated due to slow accrual)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "results might have been influenced by selection bias“ (comment in limitations and caveats)
Allocation concealment (selection bias) High risk Quote "results might have been influenced by selection bias“ (comment in limitations and caveats)
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote “masking: quadruple (participant, care provider, investigator, outcome assessor)”
Judgement comment: no other statements
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote “masking: quadruple (participant, care provider, investigator, outcome assessor)”
Judgement comment: no other statements
Incomplete outcome data (attrition bias)
All outcomes High risk Quote “primary outcome measure was not recorded for 84 participants in the Aprepitant group and 63 participants in the Placebo group”
Judgement comment: substantial amount of missing data; no reason given
Selective reporting (reporting bias) Unclear risk Judgement comment: NCT00888329 (retrospective registration)
Other bias Unclear risk Judgement comment: baseline characteristics (age): no; (weight, ASA): unclear. Potential effect modifiers (gender): no; (history of ponv/motion sickness, non‐smoker, perioperative opioids, duration of surgery): unclear