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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Supportive Care
Condition Surgery
Interventions Drug: Propofol 2mg/kg
Drug: Etomidate 0.3 mg/kg
Drug: Propofol 1 mg/kg
Drug: Etomidate 0.15 mg/kg
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group
Hide Arm/Group Description

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

Period Title: Overall Study
Started 25 25 25
Completed 25 25 25
Not Completed 0 0 0
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group Total
Hide Arm/Group Description

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

Total of all reporting groups
Overall Number of Baseline Participants 25 25 25 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 25 participants 75 participants
61.2  (8.5) 62.5  (14.7) 61.4  (11.6) 61.7  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
Female
14
  56.0%
13
  52.0%
12
  48.0%
39
  52.0%
Male
11
  44.0%
12
  48.0%
13
  52.0%
36
  48.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 25 participants 75 participants
25 25 25 75
1.Primary Outcome
Title Blood Pressure
Hide Description Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.
Time Frame 10 minutes after induction (intraoperative)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group
Hide Arm/Group Description:

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: mmHg
105  (16) 122  (23) 117.88  (18)
2.Primary Outcome
Title Heart Rate
Hide Description Heart Rate changes during induction (Beats Per min)
Time Frame 10 minutes after induction (intraoperative)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group
Hide Arm/Group Description:

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: bpm
77  (17) 74  (12) 74  (11)
3.Secondary Outcome
Title Pain at Injection Site
Hide Description 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.
Time Frame intraoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group
Hide Arm/Group Description:

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

Overall Number of Participants Analyzed 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
7
  28.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Myoclonic Movements
Hide Description 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.
Time Frame intraoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group
Hide Arm/Group Description:

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

Overall Number of Participants Analyzed 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.0%
6
  24.0%
1
   4.0%
5.Secondary Outcome
Title Post-operative Nausea and Vomiting
Hide Description Presence of post-operative nausea or vomiting (yes/no).
Time Frame 24 hours post-operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group
Hide Arm/Group Description:

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

Overall Number of Participants Analyzed 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   4.0%
2
   8.0%
6.Secondary Outcome
Title Sedation Depth
Hide Description 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.
Time Frame 30 minutes post-induction
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group
Hide Arm/Group Description:

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
30  (8.4) 38  (11) 38  (13)
7.Secondary Outcome
Title Eyelash Reflex Disappear Time
Hide Description Time to disappearance of eyelash reflex after induction.
Time Frame Post induction, up to 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group
Hide Arm/Group Description:

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: minutes
31.9  (8.3) 34.5  (7.5) 32.4  (9)
8.Secondary Outcome
Title Intubation Time
Hide Description Duration of orotracheal intubation.
Time Frame Up to 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group
Hide Arm/Group Description:

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

Overall Number of Participants Analyzed 25 25 25
Mean (Standard Deviation)
Unit of Measure: minutes
92  (9.6) 95  (8.9) 93  (9.5)
Time Frame duration in-hospital up to 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propofol Group Etomidate Group Propofol Plus Etomidate Group
Hide Arm/Group Description

Propofol 2 mg/kg

Propofol 2mg/kg: 2 mg/kg

Etomidate 0.3 mg/kg

Etomidate 0.3 mg/kg: 0.3 mg/kg

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Propofol 1 mg/kg: 1 mg/kg Propofol

Etomidate 0.15 mg/kg: 0.15 mg/kg Etomidate

All-Cause Mortality
Propofol Group Etomidate Group Propofol Plus Etomidate Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Hide Serious Adverse Events
Propofol Group Etomidate Group Propofol Plus Etomidate Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Propofol Group Etomidate Group Propofol Plus Etomidate Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hong Liu
Organization: University of California Davis
Phone: 916-734-5031
EMail: hualiu@ucdavis.edu
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03820388    
Other Study ID Numbers: 909765
First Submitted: January 9, 2018
First Posted: January 29, 2019
Results First Submitted: December 2, 2020
Results First Posted: February 23, 2021
Last Update Posted: February 23, 2021