Lee WS 2015.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis |
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Participants |
Baseline characteristics Palonosetron
Granisetron
Ramosetron
Included criteria: healthy female undergoing laparoscopic hysterectomy under general anaesthesia Excluded criteria: allergy to any of the experimental drugs, opioid dependence, history of PONV and motion sickness, use of antiemetic medication within 24 hours before surgery, pregnancy, inability to use patient‐controlled analgesia (PCA) IV device or to comprehend 10 cm visual analogue scale (VAS; 0, none; 10, maximum) for pain and nausea assessment, unwillingness to be enrolled in the study Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness): no; (non‐smoker, perioperative opioids): unclear |
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Interventions |
Intervention characteristics Palonosetron
Granisetron
Ramosetron
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Outcomes |
Vomiting (0 to 6 hours)
Vomiting (6 to 24 hours)
Adverse events (general notes in the publication, 48 hours' observation)
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Identification |
Sponsorship source: CKDpharm Country: South Korea Setting: inpatient, single‐centre Author's name: Won‐Suk Lee Institution: Department of Anesthesiology Surgery, Gil Medical Center, Gachon University, School of Medicine, Incheon, South Korea Email: gachonlws@gmail.com Address: Department of Anesthesiology Surgery, Gil Medical Center, Gachon University, School of Medicine, Incheon, South Korea Duration of study: November 2011 to June 2013 Language: English Study's primary outcome: incidence of complete responders during the study period Trial registry number: NCT01752374 |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "using a random number table" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "this investigator‐initiated, prospective, non‐blinded, randomized controlled trial" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "the incidence of nausea and vomiting was recorded during the assessment periods by ward nursing staff not blinded to the treatment drugs" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "all patients completed the study" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: NCT01752374 (retrospective registration) |
Other bias | Unclear risk | Quote: "the groups were comparable with respect to age, weight, duration of surgery, and ASA score" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness): no; (non‐smoker, perioperative opioids): unclear |