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Which Rapid Sequence Induction Technique Should be Used in Urgent Surgery in Children?

Which Rapid Sequence Induction Technique Should be Used in Urgent Surgery in Children?

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07428434
Enrollment
100
Registered
2026-02-23
Start date
2026-03-01
Completion date
2026-09-01
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Full Stomach, Pediatric, Rapid Sequence Induction (RSI)

Keywords

positive pressure ventilation, aspiration, desaturation, children, urgent surgery

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.

Detailed description

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

Interventions

OTHERClassical 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

Sponsors

Tunis University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 14 Years
Healthy volunteers
No

Inclusion criteria

* children under 14 years of age with a full stomach, scheduled for urgent surgery under general anesthesia

Exclusion criteria

* hemodynamic instability

Design outcomes

Primary

MeasureTime frame
Peri-Intubation Respiratory and Hemodynamic Complications in Children: Classical vs. Modified Rapid Sequence InductionFrom induction of anesthesia to 5 minutes after tracheal intubation

Countries

Tunisia

Contacts

CONTACTRym Karaborni, Hospital university assistant
karabornirym@gmail.com0021651870732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026