General Anesthesia, Target Controlled Infusion
Conditions
Brief summary
To explore the application of target controlled infusion of etomidate combined with propofol in the maintenance of anesthesia during brain surgeries.
Interventions
DRUGpropofol
DRUGetomidate
Sponsors
Henan Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 60 and 80 years Brain surgeries Body weight is between 45 to 75 kg and body mass index is no more than 30 kg/m2 American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ Expected operation duration is between 3 and 5 h Signed informed consent form
Exclusion criteria
* Serious cardiac, cerebral(acute stroke, uncontrolled seizure, sever dementia), liver, kidney, lung, endocrine disease or sepsis History of general anesthesia within 24 h before the operation Long use of hormone or history of adrenal suppression Hyperlipidaemia Long use of psychotropic substances Systolic pressure is still under 90 mm Hg after twice given of vasopressor agent Suspected abuse of narcotic analgesia Patients need to use neuromuscular blocking drugs (except intubation) Allergy to trial drug or other contraindication Pregnant or breast-feeding women Attendance of other trial past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Baseline to the end of the operation, expected to be about 6 h | Heart rate should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin. |
| Blood pressure | Baseline to the end of the operation, expected to be about 6 h | Blood pressure should be recorded before induction, 1 min, 5 min, 20 min after intubation, at the time of skin incision, skull drilling, incision of dura matter, during intracranial operation, suture of dura matter and skin. |
| Concentration of cortisol | from baseline to the end of the operation, expected to be about 6 h | Concentration of cortisol should be recorded before induction, 30 min, 1 h, 2 h after intubation, and immediately when the operation is over. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative awareness | From the beginning of induction to the end of the operation, expected to be about 6 h | — |
| Expense of anesthetics | From the beginning of induction to the end of the operation, expected to be about 6 h | — |
| Severity of agitation | Within 24 h after the operation | — |
| Use of vasoactive agent | from the beginning of induction to the end of the operation, expected to be about 6 h | The name and dose of the vasoactive agents used from the beginning of induction to the end of operation. |
| The time from stop of remifentanil to awake | The time from stop of remifentanil to awake, expected to no more than 15 min | — |
| Allergic reaction | From beginning of induction to 24 h after the operation | — |
| Postoperative nausea and vomiting | Within 24 h after the operation | — |
| Dose of etomidate and propofol | From the beginning of induction to the end of the operation, expected to be about 6 h | — |
Outcome results
None listed