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

NCT07620327 | Not Yet Recruiting Phase 4

• 1 other identifier: 09.2026.764
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-intubation Hypotension

Keywords

Push-dose adrenaline; Push-dose epinephrine; Peri-intubation hypotension; Rapid sequence intubation; Emergency department; Endotracheal intubation; Vasopressor; Epinephrine; Critical care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in mean arterial pressure from baseline

  Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation

• Change in heart rate from baseline

  Baseline, 1, 5, 10, 15, 30, 45, and 60 minutes after intubation

• Post-intubation vasopressor requirement

  1 hour and 24 hours after intubation

• Adverse events

  Within 24 hours after intubation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Push dose adrenaline

ACTIVE COMPARATOR

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

Interventions

0.9 % sodium chloride DRUG

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.

Also known as: Normal saline, Placebo

Placebo

Adrenaline DRUG

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.

Also known as: Epinephrine

Push dose adrenaline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Marmara University Pendik Training and Research Hospital: lead

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergencies

Interventions

Epinephrine; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Emre Kudu, MD

  Marmara University

  STUDY CHAIR

Central Study Contacts

Emre Kudu, MD

CONTACT

+90 5067613610; dr.emre.kudu@gmail.com

Emir Ünal, MD

CONTACT

emirunal@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention and placebo syringes will be identical in volume, color, and appearance and will be labeled only with a unique case code. Syringes will be prepared according to the randomization list by an independent non-blinded researcher who will not participate in clinical care, data collection, or outcome assessment. Participants, treating clinicians, investigators, care providers, and outcome assessors will remain blinded to group allocation until completion of data collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Model Details: 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 induction for rapid sequence intubation.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)