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

NCT02644980 | Unknown Phase 4

• 1 other identifier: XJZH20140722
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Delirium; Hemodynamic Instability

Keywords

Target Controlled Infusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Heart rate

  from the beginning of induction to the surgery over, up to 6 hrs.

• Delirium

  The right moment of patients'leaving off PACU, expected to be 2 h from the end the of operation

• Life quality

  at the time of one month right after the surgery

• Number of Participants with Serious and Non-Serious Adverse Events

  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.

Other Outcomes (3)

• Respiratory rates(HR)

  from the beginning of induction to the surgery over, up to 6 hrs.

• pulse blood oxygen saturation (SPO2)

  from the beginning of induction to the surgery over, up to 6 hrs.

• Dosage of anesthesia drug

  from the beginning of induction of anesthesia to the surgery over, up to 6 hrs.

Study Arms (2)

Etomidate

EXPERIMENTAL

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

Propofol

EXPERIMENTAL

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

Interventions

Propofol DRUG

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.

Propofol

Etomidate DRUG

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.

Also known as: Fuerli

Etomidate

Bispectral Index Monitor DEVICE

BIS monitored from beginning of anesthesia induction to the end of the surgery.

Also known as: BIS

Etomidate; Propofol

Induction of anesthesia DRUG

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.

Etomidate; Propofol

Maintenance of anesthesia DRUG

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.

Etomidate; Propofol

Tracheal Intubation OTHER

After the induction of anesthesia, Tracheal intubation is performed.

Etomidate; Propofol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~75 years old
• Selective cardiopulmonary bypass thoracoscopic mitral vales replacement surgery
• Received heart surgery for the first time
• New York Heart Association(NYHA) II\~III
• Written informed consent -

You may not qualify if:

• Emergency surgery
• Anticipated survival time \<1 yrs
• Serious heart, brain, liver,kidney,lung,endocrine diseases or serious infection
• Prolonged use of hormone or history of adrenal suppression disease
• Severe mediastinal fiber thickening or fibrous adhesions
• Allergy to experimental drug or other contraindications
• Occurred or expected occurring of difficulty airway
• Sure or suspected narcotic analgesics abuse
• History of neuro-muscular disease
• Mental instability or metal disease
• Pregnancy or brest-feeding
• Participated other clinical trial past 30 days
• Malignant hyperthermia

Sponsors & Collaborators

• Xijing Hospital: lead

MeSH Terms

Conditions

Delirium

Interventions

Propofol; Etomidate; Consciousness Monitors; Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Surgical Equipment; Equipment and Supplies; Airway Management; Therapeutics; Intubation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: January 1, 2016
• Study Start: December 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 1, 2016

Record last verified: 2015-12