Jo 2012.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis and combination prophylaxis |
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Participants |
Baseline characteristics Ramosetron (group R)
Dexamethasone (group D)
Ramosetron + dexamethasone (group RD)
Included criteria: female, scheduled for elective laparoscopic cholecystectomy under general anaesthesia Excluded criteria: ASA III or IV; smoking status; antiemetic medication within 24 hours before surgery; administration of steroids within 24 hours before surgery or during the 24 hours after surgery; gastrointestinal, renal, or hepatic disease; insulin‐dependent diabetes mellitus; obesity (body mass index > 35 kg/m²); conversion to open cholecystectomy Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness): no; (perioperative opioids): unclear |
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Interventions |
Intervention characteristics Ramosetron (group R)
Dexamethasone (group D)
Ramosetron + dexamethasone (group RD)
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Outcomes |
Vomiting (0 to 6 hours)
Vomiting (6 to 12 hours)
PONV (0 to 24 hours)
Headache (0 to 24 hours)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: Republic of Korea Setting: inpatient, single‐centre Author's name: Yong Seon Choi Institution: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea Email: yschoi@yuhs.ac Address: Department of Anesthesiology and Pain Medicine, 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: complete response during 24 hours Trial registry number: NA |
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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 computer‐generated randomization list" |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: not stated: "sequentially numbered, opaque, and sealed envelopes" (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "the envelopes were opened before anesthetic induction by a physician not involved in the study. The physician then prepared the appropriate study medication" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: no statement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "total of 146 patients were assessed for eligibility; 120 of these patients were enrolled in the study and completed surgical procedures (Fig. 1)" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Quote: "patients’ characteristics and operative data were all similar among the three groups (Table 1)" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness): no; (perioperative opioids): unclear |