THe Comparison of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients

Study Overview
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Brief Summary
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Compare the efficacy and safety of closed-loop target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients

Official Title
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The Comparison of Efficacy and Safety of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients --A Randomized Controlled Trial.

Conditions
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Adrenal Suppression, Hemodynamic Instability

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Cisatracurium
* Drug: Sufentanil
* Device: Bispectral index(BIS) monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Scheduled for Endotracheal intubated and general anesthesia for general surgery patients. Age 60-75 yrs. American Society of Anesthesia (ASA) classification I-II. Expected time of surgery is less than 3 hours. - Exclusion Criteria: Body mass index is more than 36kg/m2. Systolic blood pressure≥180 mm Hg or <90 mm Hg，diastolic blood pressure≥110 mm Hg or < 60 mm Hg. Serious cardiac,cerebral,liver,kidney,lung, endocrine disease or sepsis. Long term used hormone or adrenal suppression. Allergy to trial drug or other contraindication. Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation. Abuse of narcotic analgesia or suspected. Neuromuscular diseases. Mentally unstable or has a mental illness. Malignant Hyperthermia. Pregnant or breast-feeding women. Attended other trial past 30 days. -

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia. | Drug: Remifentanil<br>* Remifentanil 0.1-0.2μg/ ( kg•min) is continuously pumped at steady speed for analgesia for induction and maintenance of anesthesia. Remifentanil is stopped before skin closure<br>* Other names: Ruijie;Drug: Cisatracurium<br>* Cisatracurium 0.15 mg/kg for induction and 0.12 mg/kg/h continuous infusion for maintenance of anesthesia. Cisatracurium is stopped before skin closure.<br>Drug: Sufentanil<br>* Before skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection.<br>Device: Bispectral index(BIS) monitor<br>* BiS is maintained at 40-60 during anesthesia.<br>|
| Experimental: Etomidate<br>Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia. | Drug: Remifentanil<br>* Remifentanil 0.1-0.2μg/ ( kg•min) is continuously pumped at steady speed for analgesia for induction and maintenance of anesthesia. Remifentanil is stopped before skin closure<br>* Other names: Ruijie;Drug: Cisatracurium<br>* Cisatracurium 0.15 mg/kg for induction and 0.12 mg/kg/h continuous infusion for maintenance of anesthesia. Cisatracurium is stopped before skin closure.<br>Drug: Sufentanil<br>* Before skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection.<br>Device: Bispectral index(BIS) monitor<br>* BiS is maintained at 40-60 during anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect Compartment Concentration | The effect compartment concentration of etomidate or propofol are recorded at three time points,including time that patient's loss of eyelash reflex,after 30 minutes of loss of eyelash reflex and when the patient is awake （call then open their eyes). | From the beginning of induction to paitens'left of PACU, up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs | Systolic blood pressure, diastolic blood pressure, heart rate, respiration rate, pulse oxygen saturation recorded every 5 minutes during the operation. | From the beginning of induction to skin closure, up to 3 hours | 
| The amount of drugs | The amount of narcotics, sedation and muscle relaxation used in general anesthesia arr recorded when the operation is finished. | From the beginning of induction to skin closure, up to 3 hours | 
| Adrenal function | 3 ml blood sample is collected at 5 time points including before induction,30 minutes,2 hours,24 hours, 48 hours after induction; to examine the concentration of Cortisol, Aldosterone and ACTH in serum: | From entering the operating room to 48 h after induction of anesthesia. |