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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02644980
• Other study ID #: XJZH20140722
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 18, 2014
• Last updated: December 31, 2015
• Start date: December 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2015
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Delirium
• Hemodynamic Instability

Intervention

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.
• 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.

Device:
• Bispectral Index Monitor
BIS monitored from beginning of anesthesia induction to the end of the surgery.

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Yes
Other	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.	Yes
Other	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.	No
Primary	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.	Yes
Secondary	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.	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Time of recovery from anesthesia		from the time TCI is stopped to the time patients' eyes open after the surgery, up to 30 minutes.	No
Secondary	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.	No
Secondary	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.	No