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

NCT ID: NCT03820388

Last Updated: 2021-02-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-07-13

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).

Conditions

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Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Propofol Group

Propofol 2 mg/kg

Group Type EXPERIMENTAL

Propofol 2mg/kg

Intervention Type DRUG

2 mg/kg

Etomidate Group

Etomidate 0.3 mg/kg

Group Type EXPERIMENTAL

Etomidate 0.3 mg/kg

Intervention Type DRUG

0.3 mg/kg

Propofol plus Etomidate Group

Propofol 1 mg/kg plus Etomidate 0.15 mg/kg

Group Type EXPERIMENTAL

Propofol 1 mg/kg

Intervention Type DRUG

1 mg/kg Propofol

Etomidate 0.15 mg/kg

Intervention Type DRUG

0.15 mg/kg Etomidate

Interventions

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Propofol 2mg/kg

2 mg/kg

Intervention Type DRUG

Etomidate 0.3 mg/kg

0.3 mg/kg

Intervention Type DRUG

Propofol 1 mg/kg

1 mg/kg Propofol

Intervention Type DRUG

Etomidate 0.15 mg/kg

0.15 mg/kg Etomidate

Intervention Type DRUG

Other Intervention Names

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Diprivan Amidate Diprivan Amidate

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hong Liu, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California Davis Medical Center

Sacramento, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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909765

Identifier Type: -

Identifier Source: org_study_id

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