Low-dose rocuronium as an adjuvant to remifentanil for laryngeal mask airway-assisted flexible fiberoptic bronchoscopy in children: protocol for a randomized placebo-controlled trial.

BACKGROUND

Flexible fiberoptic bronchoscopy is being increasingly carried out under general anesthesia in pediatric patients. However, the optimal anesthetic protocol still remains unclear. This study aims to test the hypothesis that the addition of low-dose rocuronium during laryngeal mask airway-assisted flexible fiberoptic bronchoscopy in children can enhance procedural outcomes and improve overall management.

METHODS

In this randomized, double-blind, placebo-controlled trial, 140 children aged 1-6 years scheduled for flexible fiberoptic bronchoscopy under general anesthesia will be randomly allocated in a 1:1 ratio to either the rocuronium group or the normal saline group (n = 70 in each group). All children will receive intravenous propofol at a dose of 3 mg⋅kg-1 and remifentanil at 3 μg⋅kg-1 for anesthesia induction. This will be followed by either intravenous rocuronium at 0.3 mg⋅kg-1 or an equivalent volume of normal saline. Sevoflurane will be titrated to achieve the target anesthesia depth, while remifentanil will be initiated at a rate of 0.05 μg⋅kg-1⋅min-1 and subsequently adjusted as required. Mechanical ventilation will be performed via laryngeal mask airway and the bronchofiberscope is inserted through an adapter connected to the laryngeal mask airway. The primary endpoint, reflecting effectiveness of anesthesia, is the frequency of coughing episodes during the operation. Secondary endpoints include: (1) cumulative remifentanil dosage; (2) failure rate of flexible fiberoptic bronchoscopy operation; (3) hemodynamic changes; (4) cough scores in the post-anesthesia care unit; (5) procedure time; (6) discharge time; (7) adverse events; (8) satisfaction scores of bronchoscopist; (9) satisfaction scores of anesthesiologist; and (10) satisfaction scores of parents 24 h after the operation.

DISCUSSION: We hypothesize that the addition of low-dose rocuronium during laryngeal mask airway-assisted flexible fiberoptic bronchoscopy under general anesthesia may optimize operation conditions, reduce coughing frequency, lower remifentanil dosage and the failure rate, stabilize hemodynamic fluctuations, minimize adverse events and enhance satisfaction, thereby providing valuable reference for clinical anesthesia practice in these procedures.

STUDY PROTOCOL REGISTRATION: https://www.chictr.org.cn/showprojEN.html?proj=277486, identifier [ChiCTR2500105407].