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Etomidate/Propofol Mixture or Propofol Monotherapy Use in Patients Undergoing General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03855267
Recruitment Status : Unknown
Verified February 2019 by Guolin Wang, Tianjin Medical University General Hospital.
Recruitment status was:  Recruiting
First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Guolin Wang, Tianjin Medical University General Hospital

Study Description
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Brief Summary:
The purpose of this study was to investigate the effects of different proportions of etomidate/propofol mixture and propofol alone intravenous anesthesia on intraoperative and postoperative physiological indicators and complications, and to find out the optimal use ratio of E/P mixture.

Condition or disease Intervention/treatment Phase
Etomidate is Mixed With Propofol Drug: Propofol 20 MG/ML Drug: Propofol 20 mg/ml , etomidate 2 mg/ml Not Applicable

Detailed Description:
Propofol is one of the most commonly used intravenous anesthesia drugs clinically, the pharmacokinetic characteristics makes it very suitable for total intravenous anesthesia( TIVA), etomidate belongs to intravenous anesthesia with propofol, is a derivative of the imidazoles, its calm performance is strong, work quickly, no obvious respiratory depression, had little effects on the cardiovascular system, which, therefore, to protect the cardiovascular, maintain hemodynamic stability has a certain advantage. Our previous project showed that propofol and etomidate combined application can maintain stable hemodynamics in patients with better, reduce the occurrence of adverse reactions, can be used within 3 h of surgery anesthesia.The purpose of this study is to use propofol or etomidate/propofol mixture in combination with BIS monitoring to perform general anesthesia maintenance for patients, in order to ensure the appropriate depth of anesthesia, better maintain the hemodynamic stability of patients, reduce adverse reactions, and find the appropriate E/P mixture of the best proportion and dose.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Etomidate/Propofol Mixture or Propofol Monotherapy With Different Proportions on Circulation and Prognosis in Patients Undergoing General Anesthesia
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Group A
Propofol 20 mg/ml, recommended anesthesia induction dose of 0.1~0.125 ml/kg, anesthesia maintenance pump speed of 0.2~0.5ml/kg/h. keep bispectral index within 40 # 60
 Drug: Propofol 20 MG/ML
Pump propofol to keep bispectral index within 40 # 60
Active Comparator: GroupB
EP1:3, that is, 10ml etomidate was mixed with 30ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.
 Drug: Propofol 20 mg/ml , etomidate 2 mg/ml
Propofol was mixed with etomidate in different proportions.keep bispectral index within 40 # 60.
Active Comparator: Group C
EP1:1, that is, 20ml etomidate was mixed with 20ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.
 Drug: Propofol 20 mg/ml , etomidate 2 mg/ml
Propofol was mixed with etomidate in different proportions.keep bispectral index within 40 # 60.
Active Comparator: Group D
EP3:1, that is, 30ml etomidate was mixed with 10ml propofol, the recommended anesthesia induction dose was 0.1-0.125ml /kg, and the anesthesia maintenance pump speed was 0.2-0.5ml /kg/h.keep bispectral index within 40 # 60.Propofol 20 mg/ml,etomidate 2mg/ml.
 Drug: Propofol 20 mg/ml , etomidate 2 mg/ml
Propofol was mixed with etomidate in different proportions.keep bispectral index within 40 # 60.


Outcome Measures
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Primary Outcome Measures :
  1. blood pressure [ Time Frame: intraoperative ]
    the blood pressure is recorded (mmHg)

  2. heart rate [ Time Frame: intraoperative ]
    the heart rate is recorded(bpm)


Secondary Outcome Measures :
  1. Perioperative complications [ Time Frame: intraoperative ]
    the incidence of injection pain #nausea and vomit#intraoperative awareness and postoperative agitation.


Other Outcome Measures:
  1. Recovery time [ Time Frame: intraoperative ]
    Anesthesia awakening time and extubation time


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients undergoing elective general anesthesia surgery in 3h;
  2. American Society of Anesthesiologists gradesⅠ~III;
  3. Aged 18 to 65 years, Body Mass Index 18.5 ~ 29.9kg / m2;
  4. Hemoglobin 100 ~ 125g / L.
  5. In line with the ethics, the patients volunteered to take the test and signed the informed consent

Exclusion Criteria:

  1. Identify or suspect abuse or chronic use of narcotic sedatives and analgesics;
  2. Heart, or liver, or lung, or kidney dysfunction;
  3. Body mass index> 30kg / m2; or <18.5kg / m2
  4. Speech, hearing or mental disorders;
  5. severe diabetes, hyperkalemia ;
  6. participate in other drug clinical researches in four weeks;
  7. Poor compliance, can not complete clinical research by research program.
  8. Any cerebrovascular accident occurred within 3 months, such as stroke, TIA, etc
  9. Unstable angina and myocardial infarction occurred within 3 months;
  10. Having contraindications or allergies to experimental drugs and other narcotic drugs;
  11. Mental illness, hyperkalemia.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03855267


Contacts
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Contact: Zicheng Wang, MM 13821112922 527640484@qq.com

Locations
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China, Tianjin
Zicheng Wang Recruiting
Tianjin, Tianjin, China, 300000
Contact: Zicheng wang, MM    13821112922    527640484@qq.com   
Sponsors and Collaborators
Guolin Wang
Investigators
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Study Director: Guolin Wang, MD.PHD Tainjin Medical University General Hospita
More Information
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Responsible Party: Guolin Wang, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT03855267    
Other Study ID Numbers: GWang007
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guolin Wang, Tianjin Medical University General Hospital:
propofol
etomidate
General anesthesia
mixture
Additional relevant MeSH terms:
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Propofol
Etomidate
Hypnotics and Sedatives
Central Nervous System Depressants
 Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics