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

Phase 4

• Conditions: Perioperative Blood Glucose and Insulin
• Interventions: Drug: general anesthesia induction; Drug: Isoflurane; Drug: normal saline; Drug: Dexmedetomidine

• Registration Number: NCT02154074
• Lead Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-05
• Study Start: 2014-05
• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-30
• Last Update Submitted: 2014-05-30
• Study First Posted: 2014-06-03
• Last Update Posted: 2014-06-03
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N1 group: Isoflurane & saline	general anesthesia induction	for normal patients: inhale Isoflurane + the same volume of saline during operation
N1 group: Isoflurane & saline	normal saline	for normal patients: inhale Isoflurane + the same volume of saline during operation
N2 group: Isoflurane & Dexmedetomidine	general anesthesia induction	for normal patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation
D2 group: Isoflurane & Dexmedetomidi	general anesthesia induction	for diabetes patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation
D2 group: Isoflurane & Dexmedetomidi	Isoflurane	for diabetes patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation
D1 group: Isoflurane & saline	general anesthesia induction	for diabetes patients: inhale Isoflurane + the same volume of saline during operation
D1 group: Isoflurane & saline	Isoflurane	for diabetes patients: inhale Isoflurane + the same volume of saline during operation
D1 group: Isoflurane & saline	normal saline	for diabetes patients: inhale Isoflurane + the same volume of saline during operation
D2 group: Isoflurane & Dexmedetomidi	Dexmedetomidine	for diabetes patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation
N1 group: Isoflurane & saline	Isoflurane	for normal patients: inhale Isoflurane + the same volume of saline during operation
N2 group: Isoflurane & Dexmedetomidine	Isoflurane	for normal patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation
N2 group: Isoflurane & Dexmedetomidine	Dexmedetomidine	for normal patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation

Primary Outcome Measures

Name	Time	Method
blood glucose	from the day before surgery to 24 hours after surgery	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.
level of blood insulin	from the day before surgery to 24 hours after surgery	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.

Secondary Outcome Measures

Name	Time	Method
vital signs	duration of perioperative period	measure the blood pressure(BP),heart rate(HR) and oxygen saturation(SpO2) in the perioperative period

Trial Locations

Locations (1)

SecondXianJiaotongU; 🇨🇳 Xi'an, Shanxi, China