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

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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

Tracking Information
First Submitted Date  ICMJE January 9, 2018
First Posted Date  ICMJE January 29, 2019
Results First Submitted Date  ICMJE December 2, 2020
Results First Posted Date  ICMJE February 23, 2021
Last Update Posted Date February 23, 2021
Actual Study Start Date  ICMJE December 1, 2017
Actual Primary Completion Date July 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2020)
  • 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.
  • Heart Rate [ Time Frame: 10 minutes after induction (intraoperative) ]
    Heart Rate changes during induction (Beats Per min)
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • Blood Pressure [ Time Frame: 10 minutes after induction (intraoperative) ]
    Blood Pressure Fluctuations during Induction; change measured in mmHg
  • Heart Rate [ Time Frame: 10 minutes after induction (intraoperative) ]
    Heart Rate changes during induction (Beats Per min)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2021)
  • 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.
  • 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.
  • Post-operative Nausea and Vomiting [ Time Frame: 24 hours post-operation ]
    Presence of post-operative nausea or vomiting (yes/no).
  • 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.
  • Eyelash Reflex Disappear Time [ Time Frame: Post induction, up to 1 hour ]
    Time to disappearance of eyelash reflex after induction.
  • Intubation Time [ Time Frame: Up to 2 hours ]
    Duration of orotracheal intubation.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • 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.
  • 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.
  • Post-operative Nausea and Vomiting [ Time Frame: 24 hours post-operation ]
    Presence of post-operative nausea or vomiting (yes/no).
  • Vasoactive Agents Use [ Time Frame: 30 minutes post-induction ]
    Frequency of vasoactive agents use to treat adverse reactions of propofol/etomidate.
  • 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.
  • Eyelash Reflex Disappear Time [ Time Frame: 1 minute post-induction ]
    Time to disappearance of eyelash reflex after induction.
  • Intubation Time [ Time Frame: 5 minutes ]
    Duration of orotracheal intubation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia
Official Title  ICMJE Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia
Brief Summary Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Surgery
Intervention  ICMJE
  • Drug: Propofol 2mg/kg
    2 mg/kg
    Other Name: Diprivan
  • Drug: Etomidate 0.3 mg/kg
    0.3 mg/kg
    Other Name: Amidate
  • 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
Study Arms  ICMJE
  • Experimental: Propofol Group
    Propofol 2 mg/kg
    Intervention: Drug: Propofol 2mg/kg
  • Experimental: Etomidate Group
    Etomidate 0.3 mg/kg
    Intervention: Drug: Etomidate 0.3 mg/kg
  • Experimental: Propofol plus Etomidate Group
    Propofol 1 mg/kg plus Etomidate 0.15 mg/kg
    Interventions:
    • Drug: Propofol 1 mg/kg
    • Drug: Etomidate 0.15 mg/kg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2019)
75
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 13, 2018
Actual Primary Completion Date July 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03820388
Other Study ID Numbers  ICMJE 909765
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hong Liu, MD University of California, Davis
PRS Account University of California, Davis
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP