Comparison of Standard rapi̇d Sequential Intubation Protocol With Rocuronium in Emergency Department

Comparison of Standard rapi̇d Sequential Intubation Protocol With Rocuronium Priming Technique in Patients Registering to the Emergency Department and With Indication of Elective Intubation

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.

Study Overview

• Status: Completed
• Conditions: Rocuronium; Rapid Sequence Induction and Intubation
• Intervention / Treatment: Drug: priming with rocuronium

Detailed Description

This 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. Randomization was done according to the order of arrival of the cases. The demographic characteristics of the patients included in the study and the presence of diabetes mellitus were recorded. Routine rapid sequential intubation was performed in the standard group. In the priming group, 10% of the rocuronium dose was administered approximately 3 minutes before the induction agent. Intubation time, amount of drug used, vital signs before and after intubation, and end tidal carbon dioxide level to confirm intubation were recorded.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 0600
    • Ankara Bilkent Sehir Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
standard; standard rapid sequence intubation group (paralysis following induction)
priming; group primed with rocuronium before induction	Drug: priming with rocuronium; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
indirect perfusion	Indirect tissue perfusion interpretation with endtidal carbon dioxide levels	ten minutes

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: NURULLAH İSHAK IŞIK, M.D., Ankara Bilkent City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): January 15, 2022

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rocuronium; Rapid Sequence Induction and Intubation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: nısık

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No