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

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 4

Conditions: Delirium; Hemodynamic Instability

Treatments: Drug: Induction of anesthesia; Device: Bispectral Index Monitor; Drug: Maintenance of anesthesia; Drug: Propofol; Drug: Etomidate; Other: Tracheal Intubation

Study type: Interventional

Funder types: Other

Identifiers

NCT02644980

XJZH20140722

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups

Etomidate

Experimental group

Description:

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.

Treatment:

Other: Tracheal Intubation

Drug: Maintenance of anesthesia

Drug: Induction of anesthesia

Device: Bispectral Index Monitor

Drug: Etomidate

Propofol

Experimental group

Description:

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.

Treatment:

Other: Tracheal Intubation

Drug: Maintenance of anesthesia

Drug: Propofol

Drug: Induction of anesthesia

Device: Bispectral Index Monitor