Jung 2013.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis, dose‐finding study |
|
Participants |
Baseline characteristics Aprepitant (A80 group)
Aprepitant (A125 group)
Placebo
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)
Aprepitant (A125 group)
Placebo
|
|
Outcomes |
Vomiting (0 to 2 hours)
Vomiting (2 to 24 hours)
Headache (0 to 48 hours)
Adverse events (general notes in the publication, 24 hours' observation)
|
|
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 |