Song 2017.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Ramosetron
Palonosetron
Included criteria: 20 to 85 years of age, ASA I or II, undergoing spinal surgery (type of surgery included cervical laminoplasty, cervical anterior interbody fusion, lumbar laminectomy, posterior lumbar interbody fusion, and benign spinal cord tumour removal) Excluded criteria: administration of an antiemetic within 24 hours before surgery, regular administration of opioids or corticosteroids, history of psychiatric disorder, active drug or alcohol abuse, gastrointestinal motility disorder, severe hepatic or renal disease, uncontrolled diabetes, pregnancy, malignancy, body mass index > 35 kg/m², postoperative admission to an intensive care unit Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no |
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Interventions |
Intervention characteristics Ramosetron
Palonosetron
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Outcomes |
Vomiting (0 to 6 hours)
Adverse events (general notes in the publication, 48 hours' observation)
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Identification |
Sponsorship source: supported solely by departmental sources Country: Korea Setting: inpatient, single‐centre Author's name: Young Lan Kwak Institution: Department of Anesthesiology and Pain Medicine; and Anesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea Email: ylkwak@yuhs.ac Address: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research, Institute Yonsei University College of Medicine, 50 Yonsei‐ro, Seodaemun‐gu, Seoul 120‐752, Republic of Korea Duration of study: NA Language: English Study's primary outcome: incidence of PONV during postoperative 48 hours for patients with ABCB1 TT and non‐TT genotype who received prophylactic ramosetron or palonosetron Trial registry number: NCT02480088 |
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Notes | Repetitive dose of study drug after 24 hours | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "patients were assigned to either the ramosetron or the palonosetron group according to a computer‐generated randomization list" |
Allocation concealment (selection bias) | Low risk | Quote: "sequentially numbered opaque envelopes containing the group assignment were opened on the day of operation by a nurse who was not involved in patients’ management, and the nurse prepared the study drugs as assigned" Judgement comment: SNOSE |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "...by a nurse who was not involved in patients’ management, and the nurse prepared the study drugs as assigned. The group assignment was blinded to both patients and investigators until the end of the study" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Judgement comment: quote: "the group assignment was blinded to both patients and investigators until the end of the study" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "four patients in the palonosetron group were excluded because they were transferred to the intensive care unit after surgery (Fig. 1)" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: NCT02480088 (retrospective registration) |
Other bias | Low risk | Quote: "patient characteristics and operative data were comparable between the ramosetron and palonosetron groups, as well as between the non‐TT and TT for each group (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 |