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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820388
• Other study ID #: 909765
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: July 13, 2018

Study information

• Verified date: February 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of Etomidate plus Propofol vs. Propofol or Etomidate alone during induction of anesthesia.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 13, 2018
• Est. primary completion date: July 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Drug:
• Propofol 2mg/kg
2 mg/kg
• Etomidate 0.3 mg/kg
0.3 mg/kg
• Propofol 1 mg/kg
1 mg/kg Propofol
• Etomidate 0.15 mg/kg
0.15 mg/kg Etomidate

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Heart Rate	Heart Rate changes during induction (Beats Per min)	10 minutes after induction (intraoperative)
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.	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.	intraoperative
Secondary	Post-operative Nausea and Vomiting	Presence of post-operative nausea or vomiting (yes/no).	24 hours post-operation
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.	30 minutes post-induction
Secondary	Eyelash Reflex Disappear Time	Time to disappearance of eyelash reflex after induction.	Post induction, up to 1 hour
Secondary	Intubation Time	Duration of orotracheal intubation.	Up to 2 hours