Larsson 1988.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis |
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Participants |
Baseline characteristics Dixyrazine
Scopolamine
Placebo
Included criteria: 20 to 60 years of age; ASA I or II; scheduled for abdominal, minor orthopaedic, thyroid, or mammary surgery expected to last at least 1 hour; no patient was on continuous sedative or analgesic medication Excluded criteria: NA Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker): unclear; (perioperative opioids): yes |
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Interventions |
Intervention characteristics Dixyrazine
Scopolamine
Placebo
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Outcomes |
Sedation/drowsiness (at 24 hours)
Adverse events (general notes in the publication, 6 hours' observation)
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Identification |
Sponsorship source: NA Country: Sweden Setting: NA, single‐centre Author's name: Sylvia Larsson Institution: Department of Anesthesiology, University Hospital, Lund, Sweden Email: NA Address: NA Duration of study: NA Language: English Study's primary outcome: NA 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: "patients were randomly divided into three groups with 30 patients each" Judgement comment: 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 | Quote: "in equal volume and in a double‐blind fashion" Judgement comment: insufficient information on blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: insufficient information on blinding ("double‐blind") |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: quote: "two patients excluded because of thyrotoxic symptoms before induction of anaesthesia. 8 patients were later excluded because of following reasons: delays in operating room schedule, major surgical bleeding, anaesthesia >1 h, reoperation" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | High risk | Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia): no; (history of PONV/motion sickness, non‐smoker): unclear; (perioperative opioids): yes |