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

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.

Study Overview

• Status: Unknown
• Conditions: Perioperative Blood Glucose and Insulin
• Intervention / Treatment: Drug: general anesthesia induction; Drug: Isoflurane; Drug: normal saline; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Anticipated): 92
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hongtao Liu; Phone Number: 13572225310; Email: lannylouis@163.com

Study Locations

• China
  • Shanxi
    • Xi'an, Shanxi, China
      • Recruiting
      • SecondXianJiaotongU
      • Contact: Hongtao Liu; Phone Number: 13572225310; Email: lannylouis@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ANTICIPATED): October 1, 2014
• Study Completion (ANTICIPATED): October 1, 2014

Study Registration Dates

• First Submitted: May 28, 2014
• First Submitted That Met QC Criteria: May 30, 2014
• First Posted (ESTIMATE): June 3, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 3, 2014
• Last Update Submitted That Met QC Criteria: May 30, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Dexmedetomidine perioperative blood glucose and insulin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Inhalation; Dexmedetomidine; Isoflurane
• Other Study ID Numbers: Dexmedetomidine 20140527