Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients

Study Overview
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Brief Summary
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To explore the effect of induction and maintenance of anesthesia with etomidate on hemodynamics and oxidative stress in diabetic patients.

Conditions
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Hemodynamics, Oxidative Stress, Anesthesia

Intervention / Treatment
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* Drug: midazolam
* Drug: Penehyclidine Hydrochloride Injection
* Drug: Etomidate
* Drug: Propofol
* Drug: Fentanyl
* Drug: Cisatracurium Besilate
* Drug: Remifentanil
* Drug: Sevoflurane


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group E<br>Etomidate was used in both induction and maintenance of anesthesia. | Drug: midazolam<br>* Before induction, midazolam 0.05mg/kg will be injected intravenously.<br>* Other names: Li Yue Xi;Drug: Penehyclidine Hydrochloride Injection<br>* Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.<br>* Other names: Chang Tuo Ning;Drug: Etomidate<br>* Induction dose: 0.3 mg/kg. Maintenance dose: 10 μg•kg-1•min-1.<br>* Other names: Fu Er Li;Drug: Fentanyl<br>* During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.<br>Drug: Cisatracurium Besilate<br>* 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.<br>Drug: Remifentanil<br>* Remifentanil will be injected continuously during maintenance of anesthesia.<br>Drug: Sevoflurane<br>* Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index（BIS) between 50 to 55.<br>|
| Active Comparator: Group P<br>Propofol was used in both induction and maintenance of anesthesia. | Drug: midazolam<br>* Before induction, midazolam 0.05mg/kg will be injected intravenously.<br>* Other names: Li Yue Xi;Drug: Propofol<br>* Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h.<br>Drug: Fentanyl<br>* During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.<br>Drug: Cisatracurium Besilate<br>* 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.<br>Drug: Remifentanil<br>* Remifentanil will be injected continuously during maintenance of anesthesia.<br>Drug: Sevoflurane<br>* Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index（BIS) between 50 to 55.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial pressure | 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. | from 10 minutes before induction to 1 h after the surgery | 
| Central venous pressure | 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. | from 10 minutes before induction to 1 h after the surgery | 
| Heart rate | 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. | from 10 minutes before induction to 1 h after the surgery | 
| Respiratory rate | 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. | from 10 minutes before induction to 1 h after the surgery | 
| Oxygen saturation | 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. | from 10 minutes before induction to 1 h after the surgery | 
| Blood glucose | 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. | from 10 minutes before induction to 1 h after the surgery | 
| Insulin | 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. | from 10 minutes before induction to 1 h after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Super oxide dismutase | 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. | from 10 minutes before induction to 1 h after the surgery | 
| Glutathione | 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. | from 10 minutes before induction to 1 h after the surgery | 
| Xanthine oxidase | 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. | from 10 minutes before induction to 1 h after the surgery |