Lee MJ 2015.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis and combination prophylaxis |
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Participants |
Baseline characteristics Control (group C)
Ramosetron (group R)
Ramosetron + dexamethasone (group RD)
Included criteria: elective thyroid surgery, between 20 and 65 years of age, ASA I or II Excluded criteria: history of allergy to any drugs used in the study, gastrointestinal disease, motion sickness, diabetes mellitus, obesity (body mass index ≥ 35 kg/m²), renal or hepatic functional impairment, pregnancy, menstruation, use of antiemetic drugs or a systemic steroid 24 hours before surgery, chronic pain disorder Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV): no; (history of motion sickness, perioperative opioids): unclear |
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Interventions |
Intervention characteristics Control (group C)
Ramosetron (group R)
Ramosetron + dexamethasone (group RD)
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Outcomes |
Headache (0 to 48 hours)
Sedation/drowsiness (0 to 48 hours)
Adverse events (general notes in the publication, 48 hours' observation)
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Identification |
Sponsorship source: NA Country: Korea Setting: inpatient, NA Author's name: Cheol Lee Institution: Department of Anesthesiology and Pain Medicine, Wonkwang University College of Medicine, Iksan, Korea Email: ironyii@wku.ac.kr Address: Department of Anesthesiology and Pain Medicine, Wonkwang University College of Medicine, 344‐2, Sinyong‐dong, Iksan 570‐711, Korea Duration of study: NA Language: English Study's primary outcome: incidence of nausea, vomiting, and rescue antiemetic drug use within 48 hours postoperatively 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 | Quote: "were randomly (envelope randomization) allocated to three groups" Judgement comment: no further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Quote: "(envelope randomization)" Judgement comment: not stated; "sequentially numbered, opaque, and sealed envelopes" (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "all patients, investigators collecting the postoperative data, and nurses involved in the post‐operative care of patients were blinded to the randomization" Judgement comment: no information on blinding of anaesthesiologists provided |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "investigators collecting the postoperative data, and nurses involved in the post‐operative care of patients were blinded to the randomization" |
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 | Quote: "patient characteristics including the history of PONV, tympanic temperature, as well as operative data were similar among the groups (Table 1)" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV): no; (history of motion sickness, perioperative opioids): unclear |