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

Study Overview
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Brief Summary
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Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia.

Detailed Description
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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).

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

Conditions
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Surgery

Intervention / Treatment
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* Drug: Propofol 2mg/kg
* Drug: Etomidate 0.3 mg/kg
* Drug: Propofol 1 mg/kg
* Drug: Etomidate 0.15 mg/kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients in 3 cohorts will be administered 30 second bolus by manual hand push
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol Group<br>Propofol 2 mg/kg | Drug: Propofol 2mg/kg<br>* 2 mg/kg<br>* Other names: Diprivan;|
| Experimental: Etomidate Group<br>Etomidate 0.3 mg/kg | Drug: Etomidate 0.3 mg/kg<br>* 0.3 mg/kg<br>* Other names: Amidate;|
| Experimental: Propofol plus Etomidate Group<br>Propofol 1 mg/kg plus Etomidate 0.15 mg/kg | Drug: Propofol 1 mg/kg<br>* 1 mg/kg Propofol<br>* Other names: Diprivan;Drug: Etomidate 0.15 mg/kg<br>* 0.15 mg/kg Etomidate<br>* Other names: Amidate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Etomidate, Propofol