The Comparison of Efficacy and Safety of Target Controlled Infusion of Propofol or Etomidate at General Anesthesia in Geriatric Patients --A Randomized Controlled Trial.
Overview
- Phase
- Phase 4
- Intervention
- Bispectral index(BIS) monitor
- Conditions
- Adrenal Suppression
- Sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Enrollment
- 90
- Primary Endpoint
- Effect Compartment Concentration
- Last Updated
- 12 years ago
Overview
Brief Summary
Compare the efficacy and safety of closed-loop target controlled infusion of propofol or etomidate at general anesthesia in geriatric patients
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent.
- •Scheduled for Endotracheal intubated and general anesthesia for general surgery patients.
- •Age 60-75 yrs.
- •American Society of Anesthesia (ASA) classification I-II.
- •Expected time of surgery is less than 3 hours. -
Exclusion Criteria
- •Body mass index is more than 36kg/m
- •Systolic blood pressure≥180 mm Hg or \<90 mm Hg，diastolic blood pressure≥110 mm Hg or \< 60 mm Hg.
- •Serious cardiac,cerebral,liver,kidney,lung, endocrine disease or sepsis.
- •Long term used hormone or adrenal suppression.
- •Allergy to trial drug or other contraindication.
- •Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation.
- •Abuse of narcotic analgesia or suspected.
- •Neuromuscular diseases.
- •Mentally unstable or has a mental illness.
- •Malignant Hyperthermia.
Arms & Interventions
Propofol
Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
Intervention: Bispectral index(BIS) monitor
Propofol
Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
Intervention: Remifentanil
Propofol
Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
Intervention: Cisatracurium
Propofol
Target controlled infusion propofol, the effect compartment concentration is 3-4μg/ ml for induction and maintenance of anesthesia.
Intervention: Sufentanil
Etomidate
Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
Intervention: Remifentanil
Etomidate
Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
Intervention: Cisatracurium
Etomidate
Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
Intervention: Sufentanil
Etomidate
Target controlled infusion etomidate, the effect compartment concentration is 0.5-1.0μg/ ml for induction and maintenance of anesthesia.
Intervention: Bispectral index(BIS) monitor
Outcomes
Primary Outcomes
Effect Compartment Concentration
Time Frame: 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 Outcomes
- vital signs(From the beginning of induction to skin closure, up to 3 hours)
- The amount of drugs(From the beginning of induction to skin closure, up to 3 hours)
- Adrenal function(From entering the operating room to 48 h after induction of anesthesia.)