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

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02111265
• Other study ID #: SAHXJTUA01
• Status: Not yet recruiting
• Phase: Phase 4
• First received: April 9, 2014
• Last updated: April 10, 2014
• Start date: April 2014
• Est. completion date: July 2014

Study information

• Verified date: April 2014
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adrenal Suppression
• Hemodynamic Instability

Intervention

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
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University	Chinese Medical Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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.	Yes