Sadhasivam 1999.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis |
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Participants |
Baseline characteristics Placebo
Ondansetron
Included criteria: ASA I or II, adult female patients undergoing modified radical mastectomy for carcinoma of the breast Excluded criteria: morbid obesity, gastrointestinal disease with gastric outlet obstruction, had received drugs with an antiemetic effect within 24 hours before anaesthesia Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |
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Interventions |
Intervention characteristics Placebo
Ondansetron
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Outcomes |
Vomiting (0 to 24 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: India Setting: inpatient, single‐centre Author's name: Abha Saxena Institution: Department of Anesthesiology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India Email: saxenas@medinst.ernet.in Address: Department of Anesthesiology, Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India 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 allocated to receive, in a randomized, double‐blinded manner, a single dose of either ondansetron 4 mg (4 mL) IV or saline at an equal volume (4 mL) as a placebo at the end of the surgery" Judgement comment: no 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: "patients were allocated to receive, in a randomized, double‐blinded manner, a single dose of either ondansetron 4 mg (4 mL) IV or saline at an equal volume (4 mL) as a placebo at the end of the surgery" Judgement comment: insufficient information on blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: insufficient information on blinding ("double‐blinded manner") |
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: "there were no significant differences between the groups with regard to age, weight, ASA physical status, duration of anesthesia, and intraoperative and postoperative analgesic requirements (Table 1)" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness, perioperative opioids): no; (non‐smoker): unclear |