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

February 16, 2026 updated by: Mehdi Trifa, Tunis University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Rym Karaborni, Hospital university assistant
  • Phone Number: 0021651870732
  • Email: karabornirym@gmail.com

Study Locations

  • Tunisia
    • Bab Saadoun
      • Tunis, Bab Saadoun, Tunisia, 2001
        • Bechir Hamza Children Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • hemodynamic instability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Classical Rapid Sequence Induction group
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 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
Experimental: Modified Rapid Sequence Induction (mRSI) group
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 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
From induction of anesthesia to 5 minutes after tracheal intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tunis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 242025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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