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

• 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: University of California, Davis
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Propofol Group	Etomidate Group	Propofol Plus Etomidate Group
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

Baseline Characteristics

Arm/Group Title		Propofol Group	Etomidate Group	Propofol Plus Etomidate Group	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Blood Pressure
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol Group	Etomidate Group	Propofol Plus Etomidate Group
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
Description	Heart Rate changes during induction (Beats Per min)
Time Frame	10 minutes after induction (intraoperative)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol Group	Etomidate Group	Propofol Plus Etomidate Group
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol Group	Etomidate Group	Propofol Plus Etomidate Group
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol Group	Etomidate Group	Propofol Plus Etomidate Group
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
Description	Presence of post-operative nausea or vomiting (yes/no).
Time Frame	24 hours post-operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol Group	Etomidate Group	Propofol Plus Etomidate Group
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol Group	Etomidate Group	Propofol Plus Etomidate Group
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
Description	Time to disappearance of eyelash reflex after induction.
Time Frame	Post induction, up to 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol Group	Etomidate Group	Propofol Plus Etomidate Group
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
Description	Duration of orotracheal intubation.
Time Frame	Up to 2 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propofol Group	Etomidate Group	Propofol Plus Etomidate Group
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)

Adverse Events

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
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%)
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Hong Liu
• Organization: University of California Davis
• Phone: 916-734-5031
• EMail: hualiu@ucdavis.edu

• 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