Yoon 2009.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Ondansetron (group O)
Ramosetron (group R)
Included criteria: either sex, ASA I and II, scheduled middle ear surgery (mastoidectomy and tympanoplasty) under general anaesthesia with sevoflurane and remifentanil, 30 to 65 years of age Excluded criteria: cardiovascular, respiratory, brain, renal, hepatic disease; pregnant women; severe obesity; usual vomiting or motion sickness; nausea or vomiting within 24 hours before surgery Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of motion sickness): no; (history of PONV, non‐smoker, perioperative opioids): unclear |
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Interventions |
Intervention characteristics Ondansetron (group O)
Ramosetron (group R)
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Outcomes |
Vomiting (0 to 6 hours)
Vomiting (6 to 24 hours)
Headache (0 to 48 hours)
Constipation (0 to 48 hours)
Sedation/drowsiness (0 to 48 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: South Korea Setting: inpatient, single‐centre Author's name: Sang Ho Jung Institution: Department of Anesthesiology and Pain Medicine, Maryknoll Hospital Email: inature7@naver.com Address: Maryknoll Hospital, Daecheong‐dong 4ga, Jung‐gu, Busan 600‐730, Korea Duration of study: NA Language: Korean (Google Translator) Study's primary outcome: incidence of PONV Trial registry number: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Judgement comment: quote: "randomly assigned". No further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Judgement comment: insufficient information on blinding ("double‐blinded") |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: quote: "an anesthesiologist who did not know the patient's group visited the patient for 6 hours, 6‐24 hours, and 24‐48 hours postoperatively" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: no missing outcome data |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of motion sickness): no; (history of PONV, non‐smoker, perioperative opioids): unclear |