Trial Outcomes & Findings for Comparison of Etomidate Plus Propofol, Etomidate Alone on Induction of Anesthesia (NCT NCT03820388)

NCT ID: NCT03820388

Last Updated: 2021-02-23

Results Overview

Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 75 participants
• Primary outcome timeframe: 10 minutes after induction (intraoperative)
• Results posted on: 2021-02-23

Participant Flow

Participant milestones

Measure	Propofol Group Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg	Etomidate Group Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg	Propofol Plus Etomidate Group 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 Study STARTED	25	25	25
Overall Study COMPLETED	25	25	25
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Propofol Group n=25 Participants Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg	Etomidate Group n=25 Participants Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg	Propofol Plus Etomidate Group n=25 Participants 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 n=75 Participants Total of all reporting groups
Age, Continuous	61.2 years STANDARD_DEVIATION 8.5 • n=25 Participants	62.5 years STANDARD_DEVIATION 14.7 • n=25 Participants	61.4 years STANDARD_DEVIATION 11.6 • n=25 Participants	61.7 years STANDARD_DEVIATION 11.6 • n=75 Participants
Sex: Female, Male Female	14 Participants n=25 Participants	13 Participants n=25 Participants	12 Participants n=25 Participants	39 Participants n=75 Participants
Sex: Female, Male Male	11 Participants n=25 Participants	12 Participants n=25 Participants	13 Participants n=25 Participants	36 Participants n=75 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	25 participants n=25 Participants	25 participants n=25 Participants	75 participants n=75 Participants

PRIMARY outcome

Timeframe: 10 minutes after induction (intraoperative)

Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.

Outcome measures

Measure	Propofol Group n=25 Participants Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg	Etomidate Group n=25 Participants Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg	Propofol Plus Etomidate Group n=25 Participants 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
Blood Pressure	105 mmHg Standard Deviation 16	122 mmHg Standard Deviation 23	117.88 mmHg Standard Deviation 18

PRIMARY outcome

Timeframe: 10 minutes after induction (intraoperative)

Heart Rate changes during induction (Beats Per min)

Outcome measures

Measure	Propofol Group n=25 Participants Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg	Etomidate Group n=25 Participants Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg	Propofol Plus Etomidate Group n=25 Participants 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
Heart Rate	77 bpm Standard Deviation 17	74 bpm Standard Deviation 12	74 bpm Standard Deviation 11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Propofol Group n=25 Participants Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg	Etomidate Group n=25 Participants Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg	Propofol Plus Etomidate Group n=25 Participants 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
Pain at Injection Site	7 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Propofol Group n=25 Participants Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg	Etomidate Group n=25 Participants Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg	Propofol Plus Etomidate Group n=25 Participants 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
Myoclonic Movements	1 Participants	6 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 hours post-operation

Presence of post-operative nausea or vomiting (yes/no).

Outcome measures

Measure	Propofol Group n=25 Participants Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg	Etomidate Group n=25 Participants Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg	Propofol Plus Etomidate Group n=25 Participants 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
Post-operative Nausea and Vomiting	0 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Propofol Group n=25 Participants Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg	Etomidate Group n=25 Participants Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg	Propofol Plus Etomidate Group n=25 Participants 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
Sedation Depth	30 units on a scale Standard Deviation 8.4	38 units on a scale Standard Deviation 11	38 units on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: Post induction, up to 1 hour

Time to disappearance of eyelash reflex after induction.

Outcome measures

Measure	Propofol Group n=25 Participants Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg	Etomidate Group n=25 Participants Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg	Propofol Plus Etomidate Group n=25 Participants 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
Eyelash Reflex Disappear Time	31.9 minutes Standard Deviation 8.3	34.5 minutes Standard Deviation 7.5	32.4 minutes Standard Deviation 9

SECONDARY outcome

Timeframe: Up to 2 hours

Duration of orotracheal intubation.

Outcome measures

Measure	Propofol Group n=25 Participants Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg	Etomidate Group n=25 Participants Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg	Propofol Plus Etomidate Group n=25 Participants 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
Intubation Time	92 minutes Standard Deviation 9.6	95 minutes Standard Deviation 8.9	93 minutes Standard Deviation 9.5

Adverse Events

Propofol Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etomidate Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol Plus Etomidate Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hong Liu

University of California Davis

Phone: 916-734-5031

Email: hualiu@ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place