Sinha 2006.
| Methods | Prospective randomized single‐blind study | |
| Participants | N = 130 children (as confirmed by the corresponding author on query, but 120 children reported in the publication), ASA I‐II, 1‐8 years for herniotomy/orchidopexy/plastic surgery of lower limb Excluded: BMI > 30, symptoms of respiratory tract infection, asthma, risk of aspiration, anticipated difficult airway, hearing defect, neurological disorder, taking medication known to affect electroencephalography (EEG) |
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| Interventions | Early removal ‐ The LMA was removed in the deep plane of anaesthesia when airway reflexes were still depressed Late removal ‐ The LMA was removed in the awake plane after return of airway reflexes, spontaneous activity and eye opening |
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| Outcomes | Laryngospasm Coughing Desaturation Clenching of teeth Biting of the LMA Breath holding Vomiting Excessive salivation |
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| Notes | Premedication ‐ triclofos 50 mg/kg Induction ‐ O2 + N2O + sevoflurane Maintenance ‐ O2 + N2O + sevoflurane + fentanyl and caudal with 0.125% bupivacaine |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Randomly allocated to one of the two groups using computer‐generated random numbers" |
| Allocation concealment (selection bias) | Low risk | "Sealed opaque envelopes ‐ the anaesthesiologist who was to insert the LMA opened these envelopes just prior to surgery" |
| Blinding (performance bias and detection bias) Of outcome assessor to all outcomes | High risk | "Single blinding" COMMENT ‐ Patients were blinded to achieve single blinding ‐ communicated by the authors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | COMMENT ‐ No explicit statement; 120 patients mentioned in 'Methods' and outcomes reported for 125 patients in 'Results.' On enquiry, trial authors stated that 130 patients were enrolled and 125 patients completed the study (3.9% dropout). Available case analysis performed |
| Selective reporting (reporting bias) | Low risk | COMMENT ‐ Though no explicit statement, the outcomes mentioned in methodology have been reported |