Sharma 2010.
Methods | Design: double‐blind, prospective randomized controlled trial Country: India Multisite: no International: no Treatment duration: preoperative period Follow‐up: 24 hours postoperatively Operative procedure(s): laparoscopic cholecystectomy Randomization unit: participants Analysis unit: individual | |
Participants |
Exclusion criteria included:
Randomized to:
Main characteristics of participants:
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Interventions |
Co‐interventions: none stated |
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Outcomes |
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Notes | Trial registration: not stated Funder: not stated A priori sample size estimation: not stated; post hoc calculation provided on page 385 Conducted: dates not stated Declared conflicts of interest: not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Participants were randomly allocated, but no information on the randomization process was provided. |
Allocation concealment (selection bias) | Unclear risk | Participants were randomly allocated, but no information on the randomization process was provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The study is described as being "blind" but the blinding status of the perioperative personnel was not described. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The study is described as being "blind" but the blinding status of the outcome assessor was not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals were stated. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported. |
Other bias | Low risk | There were no other sources of bias. |