NCT05343702

Brief Summary

Airway management and advanced airway management are the issues that are applied every day in emergency services and that the emergency physician should know best. Rapid sequential intubation is one of the most frequently used techniques in advanced airway management. However, anesthetic agents and paralytic agents have some concerns with some side effects. In our study, This study aimed to compare the effect of standard rapid sequential intubation protocol and application of rocuronium priming technique on the procedure time and hemodynamic profile.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

April 8, 2022

Last Update Submit

September 27, 2023

Conditions

Keywords

Rapid Sequence Induction and IntubationRocuronium

Outcome Measures

Primary Outcomes (3)

  • intubation time

    when successful endotracheal intubation is performed after induction

    ten minutes

  • blood pressure systolic and diastolic

    mmhg

    ten minutes

  • heart rate

    beats/minute

    ten minutes

Secondary Outcomes (1)

  • indirect perfusion

    ten minutes

Study Arms (2)

standard

standard rapid sequence intubation group (paralysis following induction)

priming

group primed with rocuronium before induction

Drug: priming with rocuronium

Interventions

Following induction (paralysis after onset of the induction effect) in routine rapid sequence intubation protocols While paralysis is applied, it is aimed to shorten the half-life of rocuronium by administering a subparalytic dose of rocuronium approximately 3-5 minutes before induction in the priming technique

priming

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Our study is a prospective, observational and randomized study conducted between 15.07.2021 and 01.12.2021 in Ankara City Hospital Emergency Medicine Clinic, which is a third-level emergency department with approximately 450,000 patient admissions per year. Patients who applied to the emergency department and needed rapid sequential intubation were included in our study.

You may qualify if:

  • Be over the age of 18
  • Need for advanced airway
  • To give consent or consent to participate in the study consent of relatives of those who are unable to give

You may not qualify if:

  • Have an indication of a crush (rescue) airway
  • Have one of the difficult airway predictor Look, Evaluate, Obstruction, Neck mobility criteria
  • maxillofacial anomaly or trauma
  • detected during laryngoscopy with a cormack-lehane score of 3 and 4 patients
  • Those who have inconveniences in applying ketamine to the clinic of the patient
  • with a rocuronium or ketamine allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, 0600, Turkey (Türkiye)

Location

Related Publications (1)

  • Isik NI, Ozhasenekler A, Yildirim C, Sener A, Kahraman FA, Gunaydin GP. Comparison of rocuronium priming vs. standard rapid sequence intubation technique in emergency department patients requiring intubation. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20231029. doi: 10.1590/1806-9282.20231029. eCollection 2024.

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • NURULLAH İSHAK IŞIK, M.D.

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
emergency medicine specialist

Study Record Dates

First Submitted

April 8, 2022

First Posted

April 25, 2022

Study Start

July 15, 2021

Primary Completion

December 1, 2021

Study Completion

January 15, 2022

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations