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

Xi'an Jiaotong University

Status and phase: Unknown; Phase 4

Conditions: Adrenal Suppression; Hemodynamic Instability

Treatments: Drug: Remifentanil; Device: Bispectral index(BIS) monitor; Drug: Sufentanil; Drug: Cisatracurium

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT02111265

SAHXJTUA01

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

Propofol

Experimental group

Description:

Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.

Treatment:

Drug: Cisatracurium

Drug: Remifentanil

Device: Bispectral index(BIS) monitor

Drug: Sufentanil

Etomidate

Experimental group

Description:

Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.

Treatment:

Drug: Cisatracurium

Drug: Remifentanil

Device: Bispectral index(BIS) monitor

Drug: Sufentanil