Park 2012.
| Methods | Randomized, prospective, parallel‐group study | |
| Participants | Enrolled = 92, Randomized = 85 Excluded after enrolment and before randomization = 7 Age: 2 to 6 years, ASA I‐II, elective inguinal hernia repair or hydrocelectomy as outpatients |
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| Interventions | Type of LMA: LMA Classic Early removal ‐ The LMA was removed during anaesthesia with 2.2% sevoflurane Late removal ‐ The LMA was removed when patients met the recovery criteria, including facial grimace, spontaneous eye opening, and purposeful arm movement |
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| Outcomes | Laryngospasm defined as respiratory effort without airflow despite chin lift and jaw thrust, thus requiring assisted positive pressure ventilation Coughing Desaturation (SpO2 < 95%) Breath holding defined as apnoea longer than 5 seconds Excessive secretions requiring pharyngeal suction after LMA removal LMA biting (no removal of LMA due to biting, even when the patient was fully awake) Vomiting Upper airway obstruction requiring use of airway adjuncts or airway support for both chin lift and jaw thrust |
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| Notes | No premedication Induction & maintenance ‐ sevoflurane, spontaneous respiration |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomly assigned to either anaesthesia group or the awake group using a computer‐generated random numbers table" |
| Allocation concealment (selection bias) | Unclear risk | COMMENT ‐ No description of method of allocation concealment |
| Blinding (performance bias and detection bias) Of outcome assessor to all outcomes | Low risk | "One investigator was aware of group allocation and was responsible for anaesthesia emergence and LMA removal. The other investigators observed the recovery process and recorded data. The data analyst was blinded to study group allocation" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | COMMENT ‐ All the 85 patients randomized completed the study |
| Selective reporting (reporting bias) | Low risk | COMMENT ‐ All the outcomes mentioned in methods have been reported in results |