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

Second Affiliated Hospital of Xi'an Jiaotong University90 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Adrenal Suppression Hemodynamic Instability

Interventions

RemifentanilDRUG

1. Remifentanil 0.1-0.2μg/ ( kg•min) is continuously pumped at steady speed for analgesia for induction and maintenance of anesthesia. 2. Remifentanil is stopped before skin closure

CisatracuriumDRUG

1. Cisatracurium 0.15 mg/kg for induction and 0.12 mg/kg/h continuous infusion for maintenance of anesthesia. 2. Cisatracurium is stopped before skin closure.

SufentanilDRUG

Before skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written informed consent. 2. Scheduled for Endotracheal intubated and general anesthesia for general surgery patients. 3. Age 60-75 yrs. 4. American Society of Anesthesia (ASA) classification I-II. 5. Expected time of surgery is less than 3 hours. - Exclusion Criteria: 1. Body mass index is more than 36kg/m2. 2. Systolic blood pressure≥180 mm Hg or \<90 mm Hg，diastolic blood pressure≥110 mm Hg or \< 60 mm Hg. 3. Serious cardiac,cerebral,liver,kidney,lung, endocrine disease or sepsis. 4. Long term used hormone or adrenal suppression. 5. Allergy to trial drug or other contraindication. 6. Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation. 7. Abuse of narcotic analgesia or suspected. 8. Neuromuscular diseases. 9. Mentally unstable or has a mental illness. 10. Malignant Hyperthermia. 11. Pregnant or breast-feeding women. 12. Attended other trial past 30 days. -

Outcomes

Primary Outcomes

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).

Time frame: From the beginning of induction to paitens'left of PACU, up to 4 hours

Secondary Outcomes

vital signs

Systolic blood pressure, diastolic blood pressure, heart rate, respiration rate, pulse oxygen saturation recorded every 5 minutes during the operation.

Time frame: 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.

Time frame: From the beginning of induction to skin closure, up to 3 hours

Adrenal function

1. 3 ml blood sample is collected at 5 time points including before induction,30 minutes,2 hours,24 hours, 48 hours after induction; 2. to examine the concentration of Cortisol, Aldosterone and ACTH in serum:

Time frame: From entering the operating room to 48 h after induction of anesthesia.

Data from ClinicalTrials.gov

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