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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03820388
Enrollment
75
Registered
2019-01-29
Start date
2017-12-01
Completion date
2018-07-13
Last updated
2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

Etomidate, Propofol

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).

Interventions

DRUGPropofol 2mg/kg

2 mg/kg

DRUGEtomidate 0.3 mg/kg

0.3 mg/kg

DRUGPropofol 1 mg/kg

1 mg/kg Propofol

DRUGEtomidate 0.15 mg/kg

0.15 mg/kg Etomidate

Sponsors

University of California, Davis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

Patients in 3 cohorts will be administered 30 second bolus by manual hand push

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure10 minutes after induction (intraoperative)Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.
Heart Rate10 minutes after induction (intraoperative)Heart Rate changes during induction (Beats Per min)

Secondary

MeasureTime frameDescription
Post-operative Nausea and Vomiting24 hours post-operationPresence of post-operative nausea or vomiting (yes/no).
Sedation Depth30 minutes post-inductionSedation 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.
Pain at Injection SiteintraoperativePain 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.
Intubation TimeUp to 2 hoursDuration of orotracheal intubation.
Eyelash Reflex Disappear TimePost induction, up to 1 hourTime to disappearance of eyelash reflex after induction.
Myoclonic MovementsintraoperativeThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Propofol Group
Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg
25
Etomidate Group
Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg
25
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
25
Total75

Baseline characteristics

CharacteristicEtomidate GroupPropofol Plus Etomidate GroupTotalPropofol Group
Age, Continuous62.5 years
STANDARD_DEVIATION 14.7
61.4 years
STANDARD_DEVIATION 11.6
61.7 years
STANDARD_DEVIATION 11.6
61.2 years
STANDARD_DEVIATION 8.5
Race and Ethnicity Not Collected——0 Participants—
Region of Enrollment
United States
25 participants25 participants75 participants25 participants
Sex: Female, Male
Female
13 Participants12 Participants39 Participants14 Participants
Sex: Female, Male
Male
12 Participants13 Participants36 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 250 / 25
other
Total, other adverse events
0 / 250 / 250 / 25
serious
Total, serious adverse events
0 / 250 / 250 / 25

Outcome results

Primary

Blood Pressure

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)

ArmMeasureValue (MEAN)Dispersion
Propofol GroupBlood Pressure105 mmHgStandard Deviation 16
Etomidate GroupBlood Pressure122 mmHgStandard Deviation 23
Propofol Plus Etomidate GroupBlood Pressure117.88 mmHgStandard Deviation 18
Primary

Heart Rate

Heart Rate changes during induction (Beats Per min)

Time frame: 10 minutes after induction (intraoperative)

ArmMeasureValue (MEAN)Dispersion
Propofol GroupHeart Rate77 bpmStandard Deviation 17
Etomidate GroupHeart Rate74 bpmStandard Deviation 12
Propofol Plus Etomidate GroupHeart Rate74 bpmStandard Deviation 11
Secondary

Eyelash Reflex Disappear Time

Time to disappearance of eyelash reflex after induction.

Time frame: Post induction, up to 1 hour

ArmMeasureValue (MEAN)Dispersion
Propofol GroupEyelash Reflex Disappear Time31.9 minutesStandard Deviation 8.3
Etomidate GroupEyelash Reflex Disappear Time34.5 minutesStandard Deviation 7.5
Propofol Plus Etomidate GroupEyelash Reflex Disappear Time32.4 minutesStandard Deviation 9
Secondary

Intubation Time

Duration of orotracheal intubation.

Time frame: Up to 2 hours

ArmMeasureValue (MEAN)Dispersion
Propofol GroupIntubation Time92 minutesStandard Deviation 9.6
Etomidate GroupIntubation Time95 minutesStandard Deviation 8.9
Propofol Plus Etomidate GroupIntubation Time93 minutesStandard Deviation 9.5
Secondary

Myoclonic Movements

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Propofol GroupMyoclonic Movements1 Participants
Etomidate GroupMyoclonic Movements6 Participants
Propofol Plus Etomidate GroupMyoclonic Movements1 Participants
Secondary

Pain at Injection Site

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Propofol GroupPain at Injection Site7 Participants
Etomidate GroupPain at Injection Site0 Participants
Propofol Plus Etomidate GroupPain at Injection Site0 Participants
Secondary

Post-operative Nausea and Vomiting

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

Time frame: 24 hours post-operation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Propofol GroupPost-operative Nausea and Vomiting0 Participants
Etomidate GroupPost-operative Nausea and Vomiting1 Participants
Propofol Plus Etomidate GroupPost-operative Nausea and Vomiting2 Participants
Secondary

Sedation Depth

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

ArmMeasureValue (MEAN)Dispersion
Propofol GroupSedation Depth30 units on a scaleStandard Deviation 8.4
Etomidate GroupSedation Depth38 units on a scaleStandard Deviation 11
Propofol Plus Etomidate GroupSedation Depth38 units on a scaleStandard Deviation 13

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026