Effect of Push-Dose Adrenaline on Peri-intubation Hypotension During Rapid Sequence Intubation in the Emergency Department

Effect of Push-Dose Adrenaline on Peri-intubation Cardiovascular and Clinical Outcomes During Rapid Sequence Intubation in the Emergency Department: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

Rapid sequence intubation is commonly performed in the emergency department to secure the airway of critically ill patients. However, blood pressure may decrease during or shortly after intubation because of the patient's underlying illness, the effects of induction medications, and the transition to positive-pressure ventilation. This complication is known as peri-intubation hypotension and is associated with worse clinical outcomes.

This study will evaluate whether a preemptive low dose of intravenous adrenaline, also known as epinephrine, can reduce peri-intubation hypotension in adult emergency department patients undergoing rapid sequence intubation. Participants will be randomly assigned to receive either 10 mcg of intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before induction. The study will compare hemodynamic changes, vasopressor requirements, safety outcomes, and mortality between the two groups.

Study Overview

• Status: Not yet recruiting
• Conditions: Rapid Sequence Intubation; Peri-intubation Hypotension
• Intervention / Treatment: Drug: 0.9 % sodium chloride; Drug: Adrenaline

Detailed Description

Rapid sequence intubation is a standard advanced airway procedure used in emergency departments for critically ill patients who require rapid and secure airway control. Although this procedure is clinically necessary, it may be associated with peri-intubation hypotension, commonly defined as systolic blood pressure below 90 mmHg or mean arterial pressure below 65 mmHg during or after the intubation period. This hemodynamic deterioration may result from the patient's underlying critical illness, the cardiovascular effects of induction agents, reduced venous return after initiation of positive-pressure ventilation, or a combination of these factors.

Preventing hypotension during rapid sequence intubation is an important component of peri-intubation resuscitation. Intravenous fluids and vasopressor infusions are frequently used when hypotension develops, but these interventions may not always be fast enough to prevent early hemodynamic collapse. Push-dose vasopressors are used in emergency and critical care practice to provide short-term hemodynamic support. However, prospective randomized evidence regarding the preemptive use of push-dose adrenaline during emergency department rapid sequence intubation remains limited.

This is a single-center, prospective, randomized, double-blind, placebo-controlled trial conducted in the emergency department of Marmara University Pendik Training and Research Hospital. Adult patients undergoing rapid sequence intubation, who are hypotensive or considered to be at significant risk of hypotension, will be enrolled after informed consent is obtained from the patient or legally authorized representative when applicable.

Participants will be randomized in a parallel-group design to receive either 10 mcg intravenous adrenaline or 1 mL of 0.9% sodium chloride placebo immediately before the administration of induction agents. The intervention and placebo syringes will be identical in volume and appearance. Syringes will be prepared according to the randomization list by an independent non-blinded nurse who will not participate in clinical care, outcome assessment, or data collection. Treating physicians, participants, investigators, care providers, and outcome assessors will remain blinded to group allocation.

The decision to perform intubation, selection and dosing of induction and neuromuscular blocking agents, endotracheal tube size, and post-intubation management will be determined by the treating physician according to standard emergency department practice and current clinical guidance. Study procedures will not delay airway management or standard resuscitative care.

Hemodynamic variables, including systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate, will be recorded at baseline and during the first 60 minutes after intubation. The study will evaluate peri-intubation hypotension, changes in mean arterial pressure, post-intubation vasopressor requirements, new ventricular or supraventricular arrhythmias, reactive hypertension, cardiac arrest, and mortality at predefined time points. The planned enrollment is 128 participants.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Emre Kudu, MD; Phone Number: +90 5067613610; Email: dr.emre.kudu@gmail.com
• Study Contact Backup: Name: Hasan Temel, MD; Phone Number: +90 5304149909; Email: hasantemel246@gmail.com

Study Locations

• Turkey (Türkiye)
  • Pendik
    • Istanbul, Pendik, Turkey (Türkiye), 34899
      • Marmara University Pendik Training and Research Hospital
      • Contact: Emre Kudu, MD; Phone Number: +90 5067613610; Email: dr.emre.kudu@gmail.com
      • Contact: Hasan Temel, MD; Phone Number: +90 530 414 99 09; Email: hasantemel246@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients aged 18 years or older
• Patients in the emergency department for whom the treating physician has made a clinical decision to perform rapid sequence intubation
• Patients who are hypotensive, defined as systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg, or who are considered to be at significant risk of hypotension during rapid sequence intubation
• Written informed consent obtained from the patient or from a legally authorized representative when the patient lacks decision-making capacity

Exclusion Criteria:

• Pregnancy
• Known allergy to adrenaline
• Known contraindication to adrenaline administration
• Withdrawal of consent by the patient or legally authorized representative after enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Adult emergency department patients undergoing rapid sequence intubation who receive standard care and a 1 mL intravenous placebo bolus of 0.9% sodium chloride immediately before induction.	Drug: 0.9 % sodium chloride; Participants receive 1 mL of 0.9% sodium chloride intravenously as placebo immediately before the administration of induction agents for rapid sequence intubation. The placebo syringe is identical in volume and appearance to the adrenaline syringe.; Other Names: Placebo; Normal saline
Active Comparator: Push dose adrenaline; Adult emergency department patients undergoing rapid sequence intubation who receive standard care and a preemptive 10 mcg intravenous bolus dose of adrenaline immediately before induction.	Drug: Adrenaline; Participants receive 10 mcg of intravenous adrenaline, administered as 1 mL of a 10 mcg/mL dilution, immediately before the administration of induction agents for rapid sequence intubation.; Other Names: Epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-intubation hypotension	Peri-intubation hypotension will be defined as the occurrence of systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg at any time during the first 60 minutes after intubation. The incidence of peri-intubation hypotension will be compared between the adrenaline and placebo groups.	Within 60 minutes after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean arterial pressure from baseline	Mean arterial pressure will be recorded at baseline and at 1, 5, 10, 15, 30, 45, and 60 minutes after intubation. Changes from baseline will be compared between the adrenaline and placebo groups.	Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
Change in heart rate from baseline	Heart rate will be recorded at baseline and at 1, 5, 10, 15, 30, 45, and 60 minutes after intubation. Changes from baseline will be compared between the adrenaline and placebo groups.	Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation
Post-intubation vasopressor requirement	The need for continuous vasopressor infusion after intubation will be recorded. Total vasopressor dose administered during the first hour and the first 24 hours after intubation will be compared between the adrenaline and placebo groups.	1 hour and 24 hours after intubation
Adverse events	Adverse events including reactive hypertension, cardiac arrest, mortality	Within 24 hours after intubation

Collaborators and Investigators

• Sponsor: Marmara University Pendik Training and Research Hospital
• Investigators: Study Chair: Emre Kudu, MD, Marmara University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Critical care; Epinephrine; Emergency department; Endotracheal intubation; Rapid sequence intubation; Vasopressor; Push-dose adrenaline; Push-dose epinephrine; Peri-intubation hypotension
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies; Organic Chemicals; Pharmaceutical Preparations; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Inorganic Chemicals; Chlorine Compounds; Catechols; Phenols; Benzene Derivatives; Crystalloid Solutions; Isotonic Solutions; Solutions; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Sodium Compounds; Chlorides; Hydrochloric Acid; Epinephrine; Saline Solution; Sodium Chloride
• Other Study ID Numbers: 09.2026.764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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