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

Phase 4

• Conditions: Adrenal Suppression; Hemodynamic Instability
• Interventions: Drug: Remifentanil; Drug: Cisatracurium; Drug: Sufentanil; Device: Bispectral index(BIS) monitor

• Registration Number: NCT02111265
• Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study Start: 2014-04
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-09
• Last Update Submitted: 2014-04-10
• Study First Posted: 2014-04-11
• Last Update Posted: 2014-04-14
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Bispectral index(BIS) monitor	Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
Propofol	Cisatracurium	Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
Propofol	Sufentanil	Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
Etomidate	Bispectral index(BIS) monitor	Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
Propofol	Remifentanil	Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
Etomidate	Sufentanil	Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
Etomidate	Remifentanil	Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
Etomidate	Cisatracurium	Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.

Primary Outcome Measures

Name	Time	Method
Effect Compartment Concentration	From the beginning of induction to paitens'left of PACU, up to 4 hours	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).

Secondary Outcome Measures

Name	Time	Method
vital signs	From the beginning of induction to skin closure, up to 3 hours	Systolic blood pressure, diastolic blood pressure, heart rate, respiration rate, pulse oxygen saturation recorded every 5 minutes during the operation.
The amount of drugs	From the beginning of induction to skin closure, up to 3 hours	The amount of narcotics, sedation and muscle relaxation used in general anesthesia arr recorded when the operation is finished.
Adrenal function	From entering the operating room to 48 h after induction of anesthesia.	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: