Dexmedetomidine Influence on the Level of Perioperative Blood Glucose and Insulin of Elderly Diabetes Patients

Study Overview
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Brief Summary
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Dexmedetomidine is a kind of high selectivity alpha 2 agonists adrenaline, can inhibit the activity of sympathetic nerve, alleviate pain,and improve cardiovascular stability in the operation period. Dexmedetomidine have influence on perioperative stress response and immune function,but it is not clear.

Conditions
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Perioperative Blood Glucose and Insulin

Intervention / Treatment
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* Drug: general anesthesia induction
* Drug: Isoflurane
* Drug: Dexmedetomidine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 60 to 80 years old; Type 2 diabetes; Not use insulin treatment; Onging general anesthesia surgery; Surgery time 1-3 hours Exclusion Criteria: ASA classification > class II; Hypertension; Serious central nervous system diseases (acute stroke, uncontrolled seizures, -Severe dementia); Unstable angina and acute myocardial infarction; Allergy to investigational drug; Hepatic and renal dysfunction

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N1 group: Isoflurane & saline<br>for normal patients: inhale Isoflurane + the same volume of saline during operation | Drug: general anesthesia induction<br>* general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg<br>Drug: Isoflurane<br>* inhale Isoflurane 1.5MAC<br>Drug: normal saline<br>* the same volume of saline + Isoflurane during operation<br>|
| Experimental: N2 group: Isoflurane & Dexmedetomidine<br>for normal patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation | Drug: general anesthesia induction<br>* general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg<br>Drug: Isoflurane<br>* inhale Isoflurane 1.5MAC<br>Drug: Dexmedetomidine<br>* anesthesia induction period: intravenous pumping Dexmedetomidine 4ug/Kg/h; after 10 minutes,turn to 0.4ug/Kg/h.<br>|
| Active Comparator: D1 group: Isoflurane & saline<br>for diabetes patients: inhale Isoflurane + the same volume of saline during operation | Drug: general anesthesia induction<br>* general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg<br>Drug: Isoflurane<br>* inhale Isoflurane 1.5MAC<br>Drug: normal saline<br>* the same volume of saline + Isoflurane during operation<br>|
| Experimental: D2 group: Isoflurane & Dexmedetomidi<br>for diabetes patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation | Drug: general anesthesia induction<br>* general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg<br>Drug: Isoflurane<br>* inhale Isoflurane 1.5MAC<br>Drug: Dexmedetomidine<br>* anesthesia induction period: intravenous pumping Dexmedetomidine 4ug/Kg/h; after 10 minutes,turn to 0.4ug/Kg/h.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose | measure blood glucose at 3 time points,the day before surgery,Intraoperative(1 hour after surgery begain),one day after surgery(24 hours after surgery); examine the concentration of blood glucose in serum. | from the day before surgery to 24 hours after surgery | 
| level of blood insulin | measure the level of blood insulin at 3 time points,the day before surgery,Intraoperative(1 hour after surgery begain),one day after surgery(24 hours after surgery); use ELISA to examine the concentration of blood insulin in serum. | from the day before surgery to 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs | measure the blood pressure(BP),heart rate(HR) and oxygen saturation(SpO2) in the perioperative period | duration of perioperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine perioperative blood glucose and insulin