Anesthesia, Hemodynamics, Oxidative Stress
Conditions
Brief summary
To explore the effect of induction and maintenance of anesthesia with etomidate on hemodynamics and oxidative stress in diabetic patients.
Interventions
DRUGmidazolam
Before induction, midazolam 0.05mg/kg will be injected intravenously.
DRUGPenehyclidine Hydrochloride Injection
Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.
DRUGEtomidate
Induction dose: 0.3 mg/kg. Maintenance dose: 10 μg•kg-1•min-1.
DRUGPropofol
Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h.
DRUGFentanyl
During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.
Cisatracurium Besilate 0.14 mg/kg will be used after fentanyl is injected for induction. During maintenance, intermittent bolus of cisatracurium will be used for maintain muscle relaxation.
DRUGRemifentanil
Remifentanil will be injected continuously during maintenance of anesthesia.
DRUGSevoflurane
Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index（BIS) between 50 to 55.
Sponsors
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 65 years; * Diabetic patients preparing for elective surgery; * Body mass index is between 16 and 30 kg/m2; * Blood glucose is under 8.3 mmol/kg by oral antidiabetic agents or diet control; * American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ; * Expected operation duration is between 2 and 8 h; * Signed informed consent form.
Exclusion criteria
* Severe cardiac, cerebral, liver, kidney, lung, endocrine disease or infectious disease; * Chemotherapy or immunotherapy before the surgery; * Allergy to trial drug or other contraindication; * Expected or history of difficult airway; * Suspected abuse of narcotic analgesia; * Diseases of neuromuscular system; * Mentally unstable or has a mental illness; * Trend of malignant hyperthermia; * Pregnant or breast-feeding women; * Attendance of other trial past 30 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin | from 10 minutes before induction to 1 h after the surgery | Insulin will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5). Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished. |
| Respiratory rate | from 10 minutes before induction to 1 h after the surgery | Respiratory rate will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished. |
| Oxygen saturation | from 10 minutes before induction to 1 h after the surgery | Oxygen saturation will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished. |
| Blood glucose | from 10 minutes before induction to 1 h after the surgery | Blood glucose will be measured 10 min before the induction (T0), at intubation (T1), 15 min (T2) after intubation, 1 h after the beginning of the surgery (T3), when the surgery is finished (T4) and 1 h after the end of the surgery (T5). Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished. |
| Mean arterial pressure | from 10 minutes before induction to 1 h after the surgery | Mean arterial pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished. |
| Central venous pressure | from 10 minutes before induction to 1 h after the surgery | Central venous pressure will be measured 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished. |
| Heart rate | from 10 minutes before induction to 1 h after the surgery | Heart rate will be recorded 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glutathione | from 10 minutes before induction to 1 h after the surgery | 2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before glutathione was measured. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished. |
| Xanthine oxidase | from 10 minutes before induction to 1 h after the surgery | 2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before xanthine oxidase dismutase was measured. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished. |
| Super oxide dismutase | from 10 minutes before induction to 1 h after the surgery | 2 ml blood will be collected 10 min before the induction (T0), at intubation (T1), 5 min (T2), 15 min (T3) after intubation, 30 min after the beginning of the surgery (T4) and 1 h after the end of the surgery. The blood will be preserved below -20 ℃ before super oxide dismutase was measured. Beginning of the surgery: beginning of skin incision. End of the surgery: skin suture is finished. |
Outcome results
None listed