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

Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery,A Randomized Controlled Double-Blinded Study

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.

Study Overview

• Status: Unknown
• Conditions: Delirium; Hemodynamic Instability
• Intervention / Treatment: Drug: Etomidate; Device: Bispectral Index Monitor; Drug: Induction of anesthesia; Drug: Maintenance of anesthesia; Other: Tracheal Intubation; Drug: Propofol

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	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.; Other Names: Fuerli; Device: Bispectral Index Monitor; BIS monitored from beginning of anesthesia induction to the end of the surgery.; Other Names: BIS; Drug: 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.; 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.; Other: Tracheal Intubation; After the induction of anesthesia, Tracheal intubation is performed.
EXPERIMENTAL: 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.	Device: Bispectral Index Monitor; BIS monitored from beginning of anesthesia induction to the end of the surgery.; Other Names: BIS; Drug: 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.; 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.; Other: Tracheal Intubation; After the induction of anesthesia, Tracheal intubation is performed.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	blood pressure(systolic blood pressure and diastolic blood pressure) is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.	from the beginning of induction to the surgery over, up to 6 hrs.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.	from the beginning of induction to the surgery over, up to 6 hrs.
Delirium	Using Confusion Assessment Method for the Intensive Care Unit(CAM-ICU) to screening of delirium.	The right moment of patients'leaving off PACU, expected to be 2 h from the end the of operation
Life quality	using the Activities of Daily Living (ADL) to assess the life quality one month after the surgery.	at the time of one month right after the surgery
Number of Participants with Serious and Non-Serious Adverse Events	Number of Participants with Serious and Non-Serious Adverse Events including major adverse cardiovascular and cerebrovascular event such as cardiac infraction,stroke, acute renal failure, re-surgery,and death. Safety Issue?: Yes	Up to 1 month
Time of recovery from anesthesia		from the time TCI is stopped to the time patients' eyes open after the surgery, up to 30 minutes.
Bispectral index (BIS) value	BIS is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.	from the beginning of induction to the surgery over, up to 6 hrs.
onset time	The time period from TCI etomidate or propofol to the disappearance of eyelash reflex.	The time from TCI etomidate or propofol to the disappearance of eyelash reflex,up to 10 minutes.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory rates(HR)	Respiratory rate is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.	from the beginning of induction to the surgery over, up to 6 hrs.
pulse blood oxygen saturation (SPO2)	pulse blood oxygen saturation is monitored and recorded at 9 time points, including 10 minutes before induction,the right moment after induction of anesthesia and tracheal intubation,the beginning of surgery and the cardiopulmonary bypass(CPB),the time the ascending aorta is blocked and unstuck,the time the CPB and the surgery is over.	from the beginning of induction to the surgery over, up to 6 hrs.
Dosage of anesthesia drug	record the dosage of the anesthesia drug including propofol and etomidate, sufentanyl and rocuronium used during the period of maintenance of anesthesia.	from the beginning of induction of anesthesia to the surgery over, up to 6 hrs.

Collaborators and Investigators

• Sponsor: Xijing Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ANTICIPATED): August 1, 2016
• Study Completion (ANTICIPATED): August 1, 2016

Study Registration Dates

• First Submitted: August 18, 2014
• First Submitted That Met QC Criteria: December 31, 2015
• First Posted (ESTIMATE): January 1, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): January 1, 2016
• Last Update Submitted That Met QC Criteria: December 31, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Target Controlled Infusion
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Hypnotics and Sedatives; Anesthetics; Propofol; Etomidate
• Other Study ID Numbers: XJZH20140722