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Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol Group | Experimental | Propofol 2 mg/kg |
|
| Etomidate Group | Experimental | Etomidate 0.3 mg/kg |
|
| Propofol plus Etomidate Group | Experimental | Propofol 1 mg/kg plus Etomidate 0.15 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol 2mg/kg | Drug | 2 mg/kg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction. | 10 minutes after induction (intraoperative) |
| Heart Rate | Heart Rate changes during induction (Beats Per min) | 10 minutes after induction (intraoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | intraoperative |
| Myoclonic Movements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Liu, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol Group | Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg |
| FG001 | Etomidate Group | Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol Group | Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg |
| BG001 | Etomidate Group | Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure | Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction. | Posted | Mean | Standard Deviation | mmHg | 10 minutes after induction (intraoperative) |
|
duration in-hospital up to 24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol Group | Propofol 2 mg/kg Propofol 2mg/kg: 2 mg/kg | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hong Liu | University of California Davis | 916-734-5031 | hualiu@ucdavis.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2017 | Jan 6, 2021 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 26, 2017 | Jan 6, 2021 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2017 | Jan 6, 2021 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D005045 | Etomidate |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Patients in 3 cohorts will be administered 30 second bolus by manual hand push
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| Etomidate 0.3 mg/kg | Drug | 0.3 mg/kg |
|
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| Propofol 1 mg/kg | Drug | 1 mg/kg Propofol |
|
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| Etomidate 0.15 mg/kg | Drug | 0.15 mg/kg Etomidate |
|
|
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.
| intraoperative |
| Post-operative Nausea and Vomiting | Presence of post-operative nausea or vomiting (yes/no). | 24 hours post-operation |
| 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. | 30 minutes post-induction |
| Eyelash Reflex Disappear Time | Time to disappearance of eyelash reflex after induction. | Post induction, up to 1 hour |
| Intubation Time | Duration of orotracheal intubation. | Up to 2 hours |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | Heart Rate | Heart Rate changes during induction (Beats Per min) | Posted | Mean | Standard Deviation | bpm | 10 minutes after induction (intraoperative) |
|
|
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| 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. | Posted | Count of Participants | Participants | intraoperative |
|
|
|
| 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. | Posted | Count of Participants | Participants | intraoperative |
|
|
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| Secondary | Post-operative Nausea and Vomiting | Presence of post-operative nausea or vomiting (yes/no). | Posted | Count of Participants | Participants | 24 hours post-operation |
|
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 30 minutes post-induction |
|
|
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| Secondary | Eyelash Reflex Disappear Time | Time to disappearance of eyelash reflex after induction. | Posted | Mean | Standard Deviation | minutes | Post induction, up to 1 hour |
|
|
|
| Secondary | Intubation Time | Duration of orotracheal intubation. | Posted | Mean | Standard Deviation | minutes | Up to 2 hours |
|
|
|
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Etomidate Group | Etomidate 0.3 mg/kg Etomidate 0.3 mg/kg: 0.3 mg/kg | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | 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 | 0 | 25 | 0 | 25 | 0 | 25 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Male |
|