Clinical trial NCT02644980: Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery
Official title: Target Controlled Infusion of Etomidate or Propofol for Anesthesia of Thoracoscopic Mitral Valve Replacement Surgery,A Randomized Controlled Double-Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Delirium
Hemodynamic Instability
Keywords: Target Controlled Infusion
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Blood pressure
timeFrame: from the beginning of induction to the surgery over, up to 6 hrs.
Secondary outcomes:
measure: Heart rate
timeFrame: from the beginning of induction to the surgery over, up to 6 hrs.
measure: Delirium
timeFrame: The right moment of patients'leaving off PACU, expected to be 2 h from the end the of operation
measure: Life quality
timeFrame: at the time of one month right after the surgery
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: Up to 1 month
measure: Time of recovery from anesthesia
timeFrame: from the time TCI is stopped to the time patients' eyes open after the surgery, up to 30 minutes.
measure: Bispectral index (BIS) value
timeFrame: from the beginning of induction to the surgery over, up to 6 hrs.
measure: onset time
timeFrame: The time from TCI etomidate or propofol to the disappearance of eyelash reflex,up to 10 minutes.
Other outcomes:
measure: Respiratory rates(HR)
timeFrame: from the beginning of induction to the surgery over, up to 6 hrs.
measure: pulse blood oxygen saturation (SPO2)
timeFrame: from the beginning of induction to the surgery over, up to 6 hrs.
measure: Dosage of anesthesia drug
timeFrame: from the beginning of induction of anesthesia to the surgery over, up to 6 hrs.
Locations:
Study officials:
References: