Which Rapid Sequence Induction Technique Should be Used in Urgent Surgery in Children?
1 other identifier
interventional
100
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
February 23, 2026
February 1, 2026
6 months
February 16, 2026
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peri-Intubation Respiratory and Hemodynamic Complications in Children: Classical vs. Modified Rapid Sequence Induction
From induction of anesthesia to 5 minutes after tracheal intubation
Study Arms (2)
Classical Rapid Sequence Induction group
ACTIVE COMPARATORPatients 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.
Modified Rapid Sequence Induction (mRSI) group
EXPERIMENTALPatients 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- children under 14 years of age with a full stomach, scheduled for urgent surgery under general anesthesia
You may not qualify if:
- hemodynamic instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tunis Universitylead
Study Sites (1)
Bechir Hamza Children Hospital
Tunis, Bab Saadoun, 2001, Tunisia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 16, 2026
First Posted
February 23, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 23, 2026
Record last verified: 2026-02