Misra 2013.
Methods | Study design: randomized controlled trial (2 arms) Study duration: not reported Study setting: hospital, single centre, India |
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Participants | Adults undergoing elective craniotomy for tumour resection who were receiving preoperative intravenous (IV) dexamethasone for at least 48 hours (n = 79) Inclusion criteria
Exclusion criteria
Mean age, range (years)
Numbers allocated to each arm
Male gender
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Interventions |
Technique and timing
Dosage 600 mg |
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Outcomes |
Primary
Secondary
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Notes |
Funding None |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: ''randomisation was done by means of a computer‐generated random number scheme.'' Patients were allocated to receive either placebo (vitamin B‐complex capsule) (group D) or 600 mg of gabapentin (group GD), administered orally, 2 hours before the induction of anaesthesia by means of a sealed envelope. |
Allocation concealment (selection bias) | Low risk | Quote: ''patients were allocated to receive either placebo (vitamin B‐complex capsule) (group D) or 600 mg of gabapentin (group GD), administered orally, 2 hours before the induction of anaesthesia by means of a sealed envelope''. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo tablets were used to blind participants. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 6 participants were lost to follow‐up: 3 in each group due to delayed extubation. An intention‐to‐treat analysis was not used. |
Selective reporting (reporting bias) | Low risk | Outcomes reported as specified |
Other bias | High risk | Small study and no sample size calculation provided |