Savant 2016.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 2 groups, combination prophylaxis |
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Participants |
Baseline characteristics Ondansetron + dexamethasone
Granisetron + dexamethasone
Included criteria: 18 to 70 years of age, weighing more than 40 kg, ASA I or II, scheduled for oral and maxillofacial surgery under general anaesthesia Excluded criteria: unable or unwilling to give informed consent, documented hypersensitivity to any of the study drugs, history of motion sickness or previous PONV, had taken antiemetic drugs within 24 hours before surgery, history of neurological or renal disease, medically compromised and not considered fit for surgery under general anaesthesia, history of adverse reactions to study drugs Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, history of PONV/motion sickness): no; (non‐smoker, perioperative opioids): unclear |
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Interventions |
Intervention characteristics Ondansetron + dexamethasone
Granisetron + dexamethasone
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Outcomes |
Vomiting (0 to 2 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Headache (0 to 24 hours)
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Identification |
Sponsorship source: NA Country: India Setting: inpatient, single‐centre Author's name: Rakshit Vijay Sinai Khandeparke Institution: Oral and Maxillofacial Surgery, Richardsons Dental and Craniofacial Hospital, Nagercoil, India Email: rockdotcom1386@gmail.com Address: Oral and Maxillofacial Surgery, Richardsons Dental and Craniofacial Hospital, #71 Trivandrum Highway, Parvathipuram, Nagercoil, Tamil Nadu 629003, India, TEL: +91‐7868096436 Language: English Duration of study: October 2011 to October 2012 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 to the two study drug groups (A and B) and in a double blind manner" 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 | Judgement comment: insufficient information on blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Judgement comment: no statement on whether outcome assessors were blinded |
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): no; (non‐smoker, perioperative opioids): unclear |