Gupta Priyanka 2014.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 3 groups, monoprophylaxis and combination prophylaxis |
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Participants |
Baseline characteristics Dexamethasone + granisetron (group G)
Dexamethasone + ondansetron (group O)
Dexamethasone (group D)
Included criteria: ASA I to III, adult patients of either sex, scheduled for elective craniotomy for brain tumour Excluded criteria: Glasgow coma scale 14, not extubated at end of surgery, on preoperative antiemetic therapy, previous history of PONV/motion sickness/gastro‐oesophageal reflux disease, history of allergy to 5‐HT3 antagonists Pretreatment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no |
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Interventions |
Intervention characteristics Dexamethasone + granisetron (group G)
Dexamethasone + ondansetron (group O)
Dexamethasone (group D)
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Outcomes |
PONV (0 to 24 hours)
Headache (0 to 48 hours)
Constipation (0 to 48 hours)
Sedation/drowsiness (0 to 48 hours)
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Identification |
Sponsorship source: NA Country: India Setting: inpatient Author's name: Mayank Gupta Institution: Department of Anaesthesia and Intensive Care, Vardhaman Mahavir Medical College and Safdarjung Hospital, Saket, New Delhi, India Email: drm_gupta@yahoo.co.in Address: 14, Himvihar Apartments, I.P. Extension, New Delhi ‐ 110 092, India 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: "at the time of dura closure, patients were randomly assigned to one of the three groups using envelope method to receive" Judgement comment: no further information on randomization method provided |
Allocation concealment (selection bias) | Unclear risk | Quote: "using envelope method to receive" Judgement comment: not stated that envelopes were sequentially numbered, opaque, and sealed (SNOSE) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "...the time of dural closure. Study medications were prepared by an anesthetist not involved in PONV monitoring in identical 2 ml syringes. Neuromuscular blockade was reversed with..." Judgement comment: anaesthesiologist was not blinded but only received information about group allocation at dural closure. Impact on anaesthesia unknown |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "anesthetists who were blinded to group allocation recorded each episode of nausea, retching and vomiting" |
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: "...the study, 25 in each group. There were no significant differences in demographic profile [Table 1], intra‐operational characteristics [Table 2], type and anatomical location of intracranial tumors among the three groups [Table 3]. A complete response (no PONV..." Judgement comment: baseline characteristics (age, weight): no; (ASA): unclear. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of PONV/motion sickness, perioperative opioids): no |