Laha 2013.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Palonosetron
Ondansetron
Included criteria: over 18 years age, either sex, undergoing elective laparoscopic cholecystectomy at a tertiary care hospital Excluded criteria: pregnancy; body weight > 30% of ideal body weight; distinct spells of nausea, vomiting, or retching within 24 hours before surgery; use of corticosteroids, psychoactive drugs, or any other medication with known emetic or antiemetic effect within 24 hours before surgery; significant disease of major organs like liver, kidneys, heart, lungs, and bone marrow; known hypersensitivity to study medication; history of alcohol or substance abuse; participation in any other clinical trial within the last month Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear |
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Interventions |
Intervention characteristics Palonosetron
Ondansetron
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Outcomes |
Complete response (no PONV) in 24 hours
Subjects with any AE (0 to 24 hours)
Constipation (time point unknown)
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: nil Country: India Setting: inpatient, single‐centre Author's name: Avijit Hazra Institution: NA Email: ni.oc.oohay@snafwolb Address: NA Language: English Duration of study: NA Trial registry number: NA Study's primary outcome: PONV |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "simple randomization was done in 1:1 ratio on the basis of a computer generated random number list" |
Allocation concealment (selection bias) | Low risk | Quote: "generated random number list and allocation was concealed till the point of drug administration using serially numbered opaque sealed envelopes. The medication was administered..." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "single blind manner, taking care to ensure that the patient was not aware of the exact identity of the antiemetic drug" Judgement comment: personnel was aware of the study drug |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: personnel was aware of the study drug |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "the study was completed by all recruited subjects" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Judgement comment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, perioperative opioids): no; (history of PONV/motion sickness, non‐smoker): unclear |