Ketamine Versus Etomidate for Rapid Sequence Intubation

NCT ID: NCT01823328

Last Updated: 2019-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-10-31

Brief Summary

The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).

Detailed Description

This study is a randomized controlled trial of etomidate versus ketamine during rapid sequence intubation (RSI). RSI refers to the process by which patients who require emergency airway management undergo sedation and paralysis prior to insertion of an endotracheal tube(airway tube). Patients who require intubation will be randomized to have intubation performed with either ketamine or etomidate. All other care will be at the discretion of the treating physicians. The purpose of this study is to compare the efficacy and safety of ketamine and etomidate during rapid sequence intubation.

Conditions

Airway Control; Anesthesia; Intubation; Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketamine

Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI).

Group Type: ACTIVE_COMPARATOR

Ketamine

Intervention Type: DRUG

Subjects will receive ketamine for sedation prior to rapid sequence intubation.

Etomidate

Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).

Group Type: ACTIVE_COMPARATOR

Etomidate

Intervention Type: DRUG

Subjects will receive etomidate for sedation prior to rapid sequence intubation.

Interventions

Ketamine

Subjects will receive ketamine for sedation prior to rapid sequence intubation.

Intervention Type: DRUG

Etomidate

Subjects will receive etomidate for sedation prior to rapid sequence intubation.

Intervention Type: DRUG

Other Intervention Names

Ketanest; Ketaset; Ketalar; Amidate

Eligibility Criteria

Inclusion Criteria

• 18 years of age
• Undergoing rapid sequence intubation (RSI) in the Emergency Department

Exclusion Criteria

• Known contraindication to ketamine or etomidate
• Patient has a condition in which an increase in heart rate or blood pressure would be hazardous, as judged by the treating physician
• Patient is known or suspected of having increased intracranial pressure, based on the history and physical examination performed by the treating physician.
• Females of child-bearing age, defined as 18-50 years, who do not have a documented pregnancy test in this institution confirming that they are not pregnant or who do not have a confirmed surgical procedure preventing pregnancy, i.e., tubal ligation, hysterectomy. The timing of the pregnancy test at which the investigative team will consider a subject to be non-pregnant is a documented negative test during current hospitalization or upon direct transfer from outside institution during current illness.
• Patient declines participation in the trial by wearing a bracelet marked "KvE declined"
• Prisoner

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hennepin Healthcare Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian E Driver, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin County Medical Canter

Locations

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

HSR 13-3601

Identifier Type: -

Identifier Source: org_study_id