NCT02644980

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.
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.
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-01-01
• Last updated: 2016-01-01