Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia

NCT03820388 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 909765
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia.

Conditions

Surgery

Keywords

Etomidate; Propofol

Outcome Measures

Primary Outcomes (2)

• Blood Pressure

  Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.

  10 minutes after induction (intraoperative)

• Heart Rate

  Heart Rate changes during induction (Beats Per min)

  10 minutes after induction (intraoperative)

Secondary Outcomes (6)

• Pain at Injection Site

  intraoperative

• Myoclonic Movements

  intraoperative

• Post-operative Nausea and Vomiting

  24 hours post-operation

• Sedation Depth

  30 minutes post-induction

• Eyelash Reflex Disappear Time

  Post induction, up to 1 hour

Study Arms (3)

Propofol Group

EXPERIMENTAL

Propofol 2 mg/kg

Drug: Propofol 2mg/kg

Etomidate Group

EXPERIMENTAL

Etomidate 0.3 mg/kg

Drug: Etomidate 0.3 mg/kg

Propofol plus Etomidate Group

EXPERIMENTAL

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Drug: Propofol 1 mg/kg; Drug: Etomidate 0.15 mg/kg

Interventions

Propofol 2mg/kg DRUG

2 mg/kg

Also known as: Diprivan

Propofol Group

Etomidate 0.3 mg/kg DRUG

0.3 mg/kg

Also known as: Amidate

Etomidate Group

Propofol 1 mg/kg DRUG

1 mg/kg Propofol

Also known as: Diprivan

Propofol plus Etomidate Group

Etomidate 0.15 mg/kg DRUG

0.15 mg/kg Etomidate

Also known as: Amidate

Propofol plus Etomidate Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective non-cardiac surgery
• ASA physical status of 2 or 3
• Age equal to or greater than 18 years old

You may not qualify if:

• Adults unable to provide consent
• Age less than 18 years old
• Pregnant women
• Prisoners
• Difficult airway
• Morbid Obesity
• Preoperative sedation use
• Severe Cardiac, pulmonary and liver disease
• Hypotension and shock
• Emergency surgeries
• Allergy to propofol or etomidate

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Propofol; Etomidate

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Hong Liu
• Organization: University of California Davis

hualiu@ucdavis.edu

916-734-5031

Study Officials

• Hong Liu, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients in 3 cohorts will be administered 30 second bolus by manual hand push

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 29, 2019
• Study Start: December 1, 2017
• Primary Completion: July 13, 2018
• Study Completion: July 13, 2018
• Last Updated: February 23, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)