Bechir Hamza Children Hospital
Tunis, Bab Saadoun, 2001, Tunisia
NCT Number: NCT07428434
The goal of our study is to compare classical Rapid Sequence Induction (RSI) and modified Rapid Sequence Induction (mRSI) in pediatric patients with a full stomach undergoing urgent surgical procedures. Due to reduced oxygen reserve in children, modified RSI incorporating gentle positive pressure ventilation has been proposed to reduce hypoxemia while maintaining protection against aspiration.
Trial opening soon.
Get Notified1 month–14 year
All sexes
Interventional
Not applicable
Tunis, Bab Saadoun, 2001, Tunisia
This randomized clinical trial compares classical Rapid Sequence Induction (RSI) and modified Rapid Sequence Induction (mRSI) in pediatric patients with a full stomach undergoing urgent surgery. After standardized preoxygenation with 100% FiO₂ for two minutes, patients are randomized to one of two groups. In the classical RSI group, patients receive propofol (3-5 mg/kg) until loss of consciousness followed by succinylcholine (1-2 mg/kg, age-adjusted), and tracheal intubation is performed 30 seconds after induction without positive pressure ventilation. In the modified RSI group, patients receive fentanyl (4 µg/kg) prior to propofol and succinylcholine at the same doses, followed by gentle positive pressure ventilation using the anesthesia machine in inspiratory support mode (inspiratory pressure 10 cmH₂O, PEEP 5 cmH₂O) for 30 seconds before tracheal intubation. Demographic characteristics, type of surgery, heart rate, systolic and mean arterial pressure, oxygen saturation, and peri-intubation complications including aspiration and desaturation (defined as SpO₂ < 90%) are recorded and compared between groups to evaluate safety and efficacy of the two induction techniques
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients received propofol (3-5 mg/kg) until loss of consciousness, followed by succinylcholine (1-2 mg/kg, adjusted for age). Tracheal intubation was performed 30 seconds after the completion of induction, without any positive pressure ventilation
Patients received fentanyl (4 µg/kg), followed by propofol and succinylcholine at the same doses as in the RSI group. Following induction, patients received gentle positive pressure ventilation using the anesthesia machine in inspiratory support mode (inspiratory pressure: 10 cmH₂O; PEEP: 5 cmH₂O) for 30 seconds before tracheal intubation
Time frame: From induction of anesthesia to 5 minutes after tracheal intubation
Contact information is provided by the study sponsor or research team.
Tunis University
Other
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