Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism

Diabetes Clinical Trial

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Official title:

Perioperative Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02510612
• Other study ID #: 20150618
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 23, 2015
• Last updated: July 28, 2015
• Start date: August 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2015
• Source: Shaanxi Provincial People's Hospital
• Contact: Yulong Song
• Phone: 86-13519185656
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Dexmedetomidine's Sedative Effect on Diabetic Patient

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Dexmedetomidine
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
• placebo
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaanxi Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No