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

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

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

Study Overview

• Status: Unknown
• Conditions: Hemodynamic Instability; Adrenal Suppression
• Intervention / Treatment: Drug: Remifentanil; Drug: Cisatracurium; Drug: Sufentanil; Device: Bispectral index(BIS) monitor

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propofol; Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.	Drug: Remifentanil; 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; Other Names: Ruijie; Drug: Cisatracurium; 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.; Drug: Sufentanil; Before skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection.; Device: Bispectral index(BIS) monitor; BiS is maintained at 40-60 during anesthesia.
Experimental: Etomidate; Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.	Drug: Remifentanil; 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; Other Names: Ruijie; Drug: Cisatracurium; 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.; Drug: Sufentanil; Before skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection.; Device: Bispectral index(BIS) monitor; BiS is maintained at 40-60 during anesthesia.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
• Collaborators: Chinese Medical Association
• Investigators: Principal Investigator: He Jiaxuan, Department of Anesthesia, Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: April 9, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (Estimate): April 11, 2014

Study Record Updates

• Last Update Posted (Estimate): April 14, 2014
• Last Update Submitted That Met QC Criteria: April 10, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Neuromuscular Agents; Neuromuscular Blocking Agents; Remifentanil; Sufentanil; Cisatracurium
• Other Study ID Numbers: SAHXJTUA01