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

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

Study Overview

• Status: Completed
• Conditions: Surgery
• Intervention / Treatment: Drug: Propofol 2mg/kg; Drug: Etomidate 0.3 mg/kg; Drug: Propofol 1 mg/kg; Drug: Etomidate 0.15 mg/kg

Detailed Description

Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia. The specific aims are testing patient reactions during induction, and in the post-anesthesia care unit (PACU).

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol Group; Propofol 2 mg/kg	Drug: Propofol 2mg/kg; 2 mg/kg; Other Names: Diprivan
Experimental: Etomidate Group; Etomidate 0.3 mg/kg	Drug: Etomidate 0.3 mg/kg; 0.3 mg/kg; Other Names: Amidate
Experimental: Propofol plus Etomidate Group; Propofol 1 mg/kg plus Etomidate 0.15 mg/kg	Drug: Propofol 1 mg/kg; 1 mg/kg Propofol; Other Names: Diprivan; Drug: Etomidate 0.15 mg/kg; 0.15 mg/kg Etomidate; Other Names: Amidate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at Injection Site	Pain on injection will be measured using 4 graded scale; 0 = no pain, 1 = verbal complaint of pain, 2 = withdrawal of arm, 3 = both verbal complaint and withdrawal of arm.	intraoperative
Myoclonic Movements	The incidence and degree of myoclonic movements also recorded as follows: 0 = no myoclonic movements, 1 = minor myoclonic movements, 2 = moderate myoclonic movements, 3 = major myoclonic movements.	intraoperative
Post-operative Nausea and Vomiting	Presence of post-operative nausea or vomiting (yes/no).	24 hours post-operation
Sedation Depth	Sedation depth using bispectral index (BIS). BIS scores range from 0-100. A value of 0 indicates no EEG activity, 40-60 indicates an appropriate level of general anesthesia, and 90-100 is typical of a state of wakefulness.	30 minutes post-induction
Eyelash Reflex Disappear Time	Time to disappearance of eyelash reflex after induction.	Post induction, up to 1 hour
Intubation Time	Duration of orotracheal intubation.	Up to 2 hours

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Hong Liu, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): July 13, 2018
• Study Completion (Actual): July 13, 2018

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Propofol; Etomidate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol; Etomidate
• Other Study ID Numbers: 909765

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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No