Dsouza 2011.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis, dose‐finding study |
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Participants |
Baseline characteristics Dexamethasone (4 mg group)
Dexamethasone (8 mg group)
Ondansetron
Included criteria: women aged 20 to 60 years with ASA grade I or II, scheduled for gynaecological laparoscopic surgery (e.g. laparoscopic ovarian cystectomy, adhesiolysis, Burch suspension, ovarian drilling, myomectomy, tubal reanastomosis, tubal patency test) under general anaesthesia with endotracheal intubation Excluded criteria: physical status ASA III or above; lactating or menstruating; taking any medication, including corticosteroids (except oral contraceptive pills); history of motion sickness; had not complied with 6 hours of preoperative fasting; gastrointestinal disorders; had received opioids, antiemetics, or steroids in the previous month; had previous hypersensitivity to these drugs Pretreatment: baseline characteristics (ASA): no; (age, weight): unclear. Potential effect modifiers (gender, history of motion sickness): no; (history of PONV, duration of anaesthesia, non‐smoker, perioperative opioids): unclear |
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Interventions |
Intervention characteristics Dexamethasone (4 mg group)
Dexamethasone (8 mg group)
Ondansetron 4 mg
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Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 3 hours)
Vomiting (3 to 6 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Headache (overall, exact time point unknown)
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: Nita D'souza Institution: Department of Anesthesia and Intensive care, All India Institute of Medical Sciences, New Delhi, India Email: drnita610@yahoo.com Address: Doctor's Hostel, Room No. 2, JPNA Trauma Centre, AIIMS, New Delhi‐110029, India. Tel.: +91 9953008488 Language: English Duration of study: NA Trial registry number: NA Study's primary outcome: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the participants underwent simple randomization into 3 groups" Judgement comment: no further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "open‐label" Judgement comment: study was not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Judgement comment: study was not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "among the 93 patients enrolled, 1 patient from the Dexa 8 group was excluded because she failed to comply with the nil‐per‐mouth criterion" |
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 (ASA): no; (age, weight): unclear. Potential effect modifiers (gender, history of motion sickness): no; (history of PONV, duration of anaesthesia, non‐smoker, perioperative opioids): unclear |