Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery

NCT ID: NCT02644980

Last Updated: 2016-01-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-08-31

Brief Summary

For patients requiring the heart valve replacement surgery, heart function is injured in different degree.Thus, minimizing the impact of the anesthesia drug on the cardiovascular system has important clinical meanings. Etomidate has slight effect on the cardiovascular system, often used in the induction of anesthesia, however target controlled infusion etomidate in maintenance of anesthesia is less used. So, the trial is designed to observe the application value of TCI etomidate in thoracoscopic mitral valve replacement surgery.

Conditions

Delirium; Hemodynamic Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Etomidate

The initiate drug concentration of etomidate is set to 0.2 μg/ml, increasing 0.1 μg/ml every minutes until the BIS(Bispectral index ) reaches 40\~60.

Group Type: EXPERIMENTAL

Etomidate

Intervention Type: DRUG

The initiate drug concentration of etomidate is set to 0.2 μg/ml, increasing 0.1 μg/ml every minutes until the BIS(Bispectral index ) reaches 40\~60.

Bispectral Index Monitor

Intervention Type: DEVICE

BIS monitored from beginning of anesthesia induction to the end of the surgery.

Induction of anesthesia

Intervention Type: DRUG

Midazolam 0.03 mg/kg injection vein，Sufentanyl 0.5\~1 μg/kg, target controlled infusion of etomidate or propofol,after the consciousness of patients is lost, rocuronium 0.6mg/kg is given.

Maintenance of anesthesia

Intervention Type: DRUG

After the intubation, target controlled infusion(TCI) of etomidate or propofol is maintained,rocuronium 0.15mg/kg and sufentanil is given when needed. When the operation is over, the TCI is stopped.

Tracheal Intubation

Intervention Type: OTHER

After the induction of anesthesia, Tracheal intubation is performed.

Propofol

The initiate drug concentration of propofol is set to 1.0 μg/ml, increasing 0.3 μg/ml every minutes until the BIS(Bispectral index ) reaches 40\~60.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

The initiate drug concentration of propofol is set to 1.0 μg/ml, increasing 0.3 μg/ml every minutes until the BIS(Bispectral index ) reaches 40\~60.

Bispectral Index Monitor

Intervention Type: DEVICE

BIS monitored from beginning of anesthesia induction to the end of the surgery.

Induction of anesthesia

Intervention Type: DRUG

Midazolam 0.03 mg/kg injection vein，Sufentanyl 0.5\~1 μg/kg, target controlled infusion of etomidate or propofol,after the consciousness of patients is lost, rocuronium 0.6mg/kg is given.

Maintenance of anesthesia

Intervention Type: DRUG

After the intubation, target controlled infusion(TCI) of etomidate or propofol is maintained,rocuronium 0.15mg/kg and sufentanil is given when needed. When the operation is over, the TCI is stopped.

Tracheal Intubation

Intervention Type: OTHER

After the induction of anesthesia, Tracheal intubation is performed.

Interventions

Propofol

The initiate drug concentration of propofol is set to 1.0 μg/ml, increasing 0.3 μg/ml every minutes until the BIS(Bispectral index ) reaches 40\~60.

Intervention Type: DRUG

Etomidate

The initiate drug concentration of etomidate is set to 0.2 μg/ml, increasing 0.1 μg/ml every minutes until the BIS(Bispectral index ) reaches 40\~60.

Intervention Type: DRUG

Bispectral Index Monitor

BIS monitored from beginning of anesthesia induction to the end of the surgery.

Intervention Type: DEVICE

Induction of anesthesia

Midazolam 0.03 mg/kg injection vein，Sufentanyl 0.5\~1 μg/kg, target controlled infusion of etomidate or propofol,after the consciousness of patients is lost, rocuronium 0.6mg/kg is given.

Intervention Type: DRUG

Maintenance of anesthesia

After the intubation, target controlled infusion(TCI) of etomidate or propofol is maintained,rocuronium 0.15mg/kg and sufentanil is given when needed. When the operation is over, the TCI is stopped.

Intervention Type: DRUG

Tracheal Intubation

After the induction of anesthesia, Tracheal intubation is performed.

Intervention Type: OTHER

Other Intervention Names

Fuerli; BIS

Eligibility Criteria

Inclusion Criteria

1. Age 18~75 years old

2. Selective cardiopulmonary bypass thoracoscopic mitral vales replacement surgery

3. Received heart surgery for the first time

4. New York Heart Association(NYHA) II~III

5. Written informed consent -

Exclusion Criteria

1. Emergency surgery

2. Anticipated survival time <1 yrs

3. Serious heart, brain, liver,kidney,lung,endocrine diseases or serious infection

4. Prolonged use of hormone or history of adrenal suppression disease

5. Severe mediastinal fiber thickening or fibrous adhesions

6. Allergy to experimental drug or other contraindications

7. Occurred or expected occurring of difficulty airway

8. Sure or suspected narcotic analgesics abuse

9. History of neuro-muscular disease

10. Mental instability or metal disease

11. Pregnancy or brest-feeding

12. Participated other clinical trial past 30 days

13. Malignant hyperthermia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

XJZH20140722

Identifier Type: -

Identifier Source: org_study_id