An interventional study of Classical Rapid Sequence Induction and Modified Rapid Sequence Induction in Rapid Sequence Induction (RSI), Full Stomach and Pediatric, sponsored by Tunis University. Not yet recruiting at 1 site in Tunisia. Open to participants aged 1 Month to 14 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Tunis University · Not applicable, Interventional, and Other
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.
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
Tunis University is the lead sponsor of 22 studies on the registry; 5 are open to participants now.
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Patients received propofol (3-5 mg/kg) followed by age-adjusted succinylcholine (1-2 mg/kg), and tracheal intubation was performed 30 seconds later without positive pressure ventilation.
Other: Classical Rapid Sequence Induction
Patients received fentanyl (4 µg/kg) followed by propofol and succinylcholine at the same doses as the RSI group, then underwent 30 seconds of gentle positive pressure ventilation (inspiratory pressure 10 cmH₂O, PEEP 5 cmH₂O) before tracheal intubation.
Other: Modified Rapid Sequence Induction
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
Peri-Intubation Respiratory and Hemodynamic Complications in Children: Classical vs. Modified Rapid Sequence Induction
Time frame: From induction of anesthesia to 5 minutes after tracheal intubation
Start is estimated for Mar 2026; primary completion for Sep 2026, 6 months later.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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