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

Effects of Etomidate/Propofol Mixture or Propofol Monotherapy With Different Proportions on Circulation and Prognosis in Patients Undergoing General Anesthesia

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.

Study Overview

• Status: Unknown
• Conditions: Etomidate is Mixed With Propofol
• Intervention / Treatment: Drug: Propofol 20 MG/ML; Drug: Propofol 20 mg/ml , etomidate 2 mg/ml

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zicheng wang, MM; Phone Number: 13821112922; Email: 527640484@qq.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Recruiting
      • Zicheng Wang
      • Contact: Zicheng wang, MM; Phone Number: 13821112922; Email: 527640484@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	the blood pressure is recorded (mmHg)	intraoperative
heart rate	the heart rate is recorded(bpm)	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative complications	the incidence of injection pain #nausea and vomit#intraoperative awareness and postoperative agitation.	intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time	Anesthesia awakening time and extubation time	intraoperative

Collaborators and Investigators

• Sponsor: Guolin Wang
• Investigators: Study Director: Guolin Wang, MD.PHD, Tainjin Medical University General Hospita

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 24, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: propofol; General anesthesia; etomidate; mixture
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol; Etomidate
• Other Study ID Numbers: GWang007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No