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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820388
Recruitment Status : Completed
First Posted : January 29, 2019
Results First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Surgery Drug: Propofol 2mg/kg Drug: Etomidate 0.3 mg/kg Drug: Propofol 1 mg/kg Drug: Etomidate 0.15 mg/kg Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients in 3 cohorts will be administered 30 second bolus by manual hand push
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : July 13, 2018
Actual Study Completion Date : July 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propofol Group
Propofol 2 mg/kg
Drug: Propofol 2mg/kg
2 mg/kg
Other Name: Diprivan

Experimental: Etomidate Group
Etomidate 0.3 mg/kg
Drug: Etomidate 0.3 mg/kg
0.3 mg/kg
Other Name: 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 Name: Diprivan

Drug: Etomidate 0.15 mg/kg
0.15 mg/kg Etomidate
Other Name: Amidate




Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: 10 minutes after induction (intraoperative) ]
    Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.

  2. Heart Rate [ Time Frame: 10 minutes after induction (intraoperative) ]
    Heart Rate changes during induction (Beats Per min)


Secondary Outcome Measures :
  1. Pain at Injection Site [ Time Frame: intraoperative ]
    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.

  2. Myoclonic Movements [ Time Frame: intraoperative ]
    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.

  3. Post-operative Nausea and Vomiting [ Time Frame: 24 hours post-operation ]
    Presence of post-operative nausea or vomiting (yes/no).

  4. Sedation Depth [ Time Frame: 30 minutes post-induction ]
    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.

  5. Eyelash Reflex Disappear Time [ Time Frame: Post induction, up to 1 hour ]
    Time to disappearance of eyelash reflex after induction.

  6. Intubation Time [ Time Frame: Up to 2 hours ]
    Duration of orotracheal intubation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820388


Locations
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United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Hong Liu, MD University of California, Davis
  Study Documents (Full-Text)

Documents provided by University of California, Davis:
Study Protocol  [PDF] March 15, 2017
Statistical Analysis Plan  [PDF] September 26, 2017
Informed Consent Form  [PDF] September 26, 2017

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03820388    
Other Study ID Numbers: 909765
First Posted: January 29, 2019    Key Record Dates
Results First Posted: February 23, 2021
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, Davis:
Etomidate
Propofol
Additional relevant MeSH terms:
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Propofol
Etomidate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics