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Completed

NCT Number: NCT03820388

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

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

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California Davis Medical Center

Sacramento, California, 95817, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol 2mg/kg

Drug

2 mg/kg

Other names: Diprivan

Etomidate 0.3 mg/kg

Drug

0.3 mg/kg

Other names: Amidate

Propofol 1 mg/kg

Drug

1 mg/kg Propofol

Other names: Diprivan

Etomidate 0.15 mg/kg

Drug

0.15 mg/kg Etomidate

Other names: Amidate

Primary outcomes

  1. Blood Pressure

    Time frame: 10 minutes after induction (intraoperative)

    Blood Pressure Fluctuations during Induction; change of blood pressure from baseline from induction to 10 min after induction.

  2. Heart Rate

    Time frame: 10 minutes after induction (intraoperative)

    Heart Rate changes during induction (Beats Per min)

Secondary outcomes

  1. Pain at Injection Site

    Time frame: 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.

  2. Myoclonic Movements

    Time frame: 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.

  3. Post-operative Nausea and Vomiting

    Time frame: 24 hours post-operation

    Presence of post-operative nausea or vomiting (yes/no).

  4. Sedation Depth

    Time frame: 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.

  5. Eyelash Reflex Disappear Time

    Time frame: Post induction, up to 1 hour

    Time to disappearance of eyelash reflex after induction.

  6. Intubation Time

    Time frame: Up to 2 hours

    Duration of orotracheal intubation.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2019
Registry last updated
Feb 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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