Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism

Study Overview
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Brief Summary
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Dexmedetomidine's Sedative Effect on Diabetic Patient

Detailed Description
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Dexmedetomidine is a high selective α2 agonist,its sedative and analgesia feature is acclaimed. The pathogenesis of type 2 diabetes mellitus is associated with α2 excessive adrenaline receptors expression. This study is to evaluate whether the use of dexmedetomidine is helpful to Diabetic Patient through its antisympathetic effect

Official Title
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Perioperative Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 40 and 60 Selective epigastrium surgery In Exclusion Criteria: American Society of Anesthesiology (ASA) Physical Status>3 Duration of operation >3 hours Hypovolemia,sinus bradycardia,atrioventricular block,severe hepatic and renal dysfunction,severe cardiac insufficiency

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 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: Dexmedetomidine<br>Patients in group D will be given dexmedetomidine during anesthesia induction and maintenance phase respectively.In induction phase infuse 1μg/Kg of dexmedetomidine in 10 minutes， the speed in maintenance phase is 0.4μg/Kg.h | Drug: Dexmedetomidine<br>* During anesthesia induction, all patients will be given propofol,fentanyl,vecuronium bromide.But before induction start in Dexmedetomidine(D) group, patient will be given dexmedetomidine 1μg/Kg for 10 minutes In anesthesia maintenance, D group will be given dexmedetomidine 0.4μg/Kg.h until 40 minutes before the end of surgery<br>* Other names: Yi Si;|
| Placebo Comparator: placebo<br>Patients in group P will be given normal saline during anesthesia induction and maintenance phase | Drug: placebo<br>* During anesthesia induction, all patients will be given propofol,fentanyl,vecuronium bromide.But before induction start in Placebo(P) group, patient will be given placebo for 10 minutes In anesthesia maintenance, D group will be given placebo until 40 minutes before the end of surgery<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sedation level | Ramsay score and BIS will be recorded before medication,5 min after medication, medication ending, 5 and 10 min after medication | from 5 minutes before medication to 10 minutes after Dexmedetomidine discontinuance，length of time frame is about 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | recorded at before medication,5 min after medication, medication ending, 5 and 10 min after medication, before intubation, after intubation, after skin incision,60 minutes after skin incision, after extubation,first day after operation | participants will be followed from operation day to first postoperative day，an expected average of 2 days | 
| Mean arterial pressure | 10 min after medication, before intubation, after intubation, after skin incision,60 minutes after skin incision, after extubation,first day after operation | participants will be followed from operation day to first postoperative day，an expected average of 2 days | 
| blood glucose measured by Biochemical test | it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation | participants will be followed from operation day to first postoperative day，an expected average of 2 days | 
| cortisol measured by Biochemical test | it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation | participants will be followed from operation day to first postoperative day，an expected average of 2 days | 
| insulin measured by Biochemical test | it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation | participants will be followed from operation day to first postoperative day，an expected average of 2 days | 
| adrenaline measured by Biochemical test | it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation | participants will be followed from operation day to first postoperative day，an expected average of 2 days | 
| noradrenaline measured by Biochemical test | it will be recorded immediately after the entrance to the operating room, before operation, 60 minutes after incision, after extubation, first day after operation | participants will be followed from operation day to first postoperative day，an expected average of 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Diabetic, glycometabolism, sedation