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

Phase 4

Completed

• Conditions: Surgery
• Interventions: Drug: Etomidate 0.3 mg/kg; Drug: Propofol 1 mg/kg; Drug: Propofol 2mg/kg; Drug: Etomidate 0.15 mg/kg

• Registration Number: NCT03820388
• Lead Sponsor: University of California, Davis

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).

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-01-09
• Primary Completion: 2018-07-13
• Study Completion: 2018-07-13
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-29
• Results First Submitted: 2020-12-02
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-04
• Last Update Submitted: 2021-02-04
• Results First Posted: 2021-02-23
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etomidate Group	Etomidate 0.3 mg/kg	Etomidate 0.3 mg/kg
Propofol plus Etomidate Group	Propofol 1 mg/kg	Propofol 1 mg/kg plus Etomidate 0.15 mg/kg
Propofol plus Etomidate Group	Etomidate 0.15 mg/kg	Propofol 1 mg/kg plus Etomidate 0.15 mg/kg
Propofol Group	Propofol 2mg/kg	Propofol 2 mg/kg

Primary Outcome Measures

Name	Time	Method
Blood Pressure	10 minutes after induction (intraoperative)	Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.
Heart Rate	10 minutes after induction (intraoperative)	Heart Rate changes during induction (Beats Per min)

Secondary Outcome Measures

Name	Time	Method
Post-operative Nausea and Vomiting	24 hours post-operation	Presence of post-operative nausea or vomiting (yes/no).
Eyelash Reflex Disappear Time	Post induction, up to 1 hour	Time to disappearance of eyelash reflex after induction.
Pain at Injection Site	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.
Myoclonic Movements	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.
Sedation Depth	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.
Intubation Time	Up to 2 hours	Duration of orotracheal intubation.

Trial Locations

Locations (1)

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States