Evaluating the Hemodynamic Effects of Ketamine Versus Etomidate During Rapid Sequence Intubation

NCT03545503 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1712-4
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the hemodynamic effects of ketamine v etomidate during rapid sequence intubation (RSI) in the pre-hospital and emergency department setting.

Conditions

Intubation Complication

Keywords

Rapid Sequence Intubation; Hemodynamics; Etomidate; Ketamine

Outcome Measures

Primary Outcomes (1)

• Hemodynamic Effect as Measured by Systolic Blood Pressure Before and After RSI

  The primary outcome of this study is to determine the change in hemodynamic response comparing systolic blood pressure pre-versus post-administration of study drug. A significant hemodynamic response is defined as a decrease in systolic blood pressure of 20% or greater between the pre versus post administered study drug.

  The hemodynamic response will be measured by assessing the change in vital signs between 15 minutes prior to administration and vitals up to 15 minutes after the administration of the study drug.

Study Arms (2)

Etomidate

ACTIVE COMPARATOR

Etomidate will be dosed once at a standard of 0.3 mg/kg via IV Push

Drug: Etomidate

Ketamine

ACTIVE COMPARATOR

Ketamine will be dosed once at a standard 2 mg/kg via IV Push

Drug: Ketamine

Interventions

Etomidate DRUG

Etomidate will be administered as the sedative for RSI on even days

Also known as: Amidate

Etomidate

Ketamine DRUG

Ketamine will be administered as the sedative for RSI on odd days

Also known as: Ketalar

Ketamine

Eligibility Criteria

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

You may qualify if:

• Persons greater than 18yrs requiring rapid sequence intubation for any reason.

You may not qualify if:

• Pregnant patients
• Children under the age of 18
• Patients with a known hypersensitivity to etomidate or ketamine

Sponsors & Collaborators

• South East Area Health Education Center, Wilmington, NC: lead
• New Hanover Regional Medical Center: collaborator

Study Sites (1)

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

MeSH Terms

Interventions

Etomidate; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Investigators nor clinicians were blinded to study drug. Resuscitation pre-RSI was not accounted for nor was the dosing for vascopressors. We could not control the slow administration of ketamine to decrease effects of hypotension due to rapid administration.

Results Point of Contact

• Title: William F. Powers, IV, MD, FACS
• Organization: New Hanover Regional Medical Center

william.powers@nhrmc.org

910-667-9232

Study Officials

• William F Powers IV, MD

  New Hanover Regional Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: June 4, 2018
• Study Start: January 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: November 26, 2021
• Results First Posted: November 26, 2021

Record last verified: 2021-10

Locations

US (1)