Shora 2007.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, monoprophylaxis and combination prophylaxis |
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Participants |
Baseline characteristics Ondansetron
Ondansetron + dexamethasone
Included criteria: female, 18 to 55 years of age, ASA I or II, undergoing laparoscopic cholecystectomy under general anaesthesia Excluded criteria: history of motion sickness, migraine, PONV during previous surgery, pregnant or lactating 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 Ondansetron
Ondansetron + dexamethasone
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Outcomes |
Vomiting (0 to 6 hours)
Vomiting (12 to 18 hours)
PONV (0 to 24 hours)
Complete response (no PONV) in 24 hours
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Identification |
Sponsorship source: NA Country: India Setting: inpatient, single‐centre Author's name: Asaf Nazir Shora Institution: Sher‐i‐Kashmir Institute of Medical Sciences Email: NA Address: Soura, Bemina, Srinagar, Jammu and Kashmir 190011 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: "patients were randomly allocated into two groups of 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: "patients included in the study. In the preoperative holding area, patients were randomly allocated into two groups of 30 patients each and received study medications prepared by a single person in identical 5 ml syringe and all study medications were diluted up to 4 ml in 0.9 % saline in order to ensure blinding" Judgement comment: it is unclear whether the person preparing the syringes was further involved in the study |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "after surgery patients were observed for a period of 24 hours by the same anaesthetist" Judgement comment: insufficient information on blinding of outcome assessors |
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 | 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 |