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

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02154074
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Arms: 4
• Duration (Months): 5
• Patients Per Site Per Month: 18.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perioperative Blood Glucose and Insulin	Drug: general anesthesia induction; Drug: Isoflurane; Drug: Dexmedetomidine; Drug: normal saline	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 92 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2014
• Anticipated Primary Completion Date: Oct 1, 2014
• Anticipated Study Completion Date: Oct 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. vital signs [duration of perioperative period]

   measure the blood pressure(BP),heart rate(HR) and oxygen saturation(SpO2) in the perioperative period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SecondXianJiaotongU	Xi'an	Shanxi	China

Sponsors and Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital of Xi'an Jiaotong University
• ClinicalTrials.gov Identifier: NCT02154074
• Other Study ID Numbers: Dexmedetomidine 20140527
• First Posted: Jun 3, 2014
• Last Update Posted: Jun 3, 2014
• Last Verified: May 1, 2014

• Keywords provided by Second Affiliated Hospital of Xi'an Jiaotong University: Dexmedetomidine perioperative blood glucose and insulin
• Additional relevant MeSH terms: Dexmedetomidine; Isoflurane

Study Results

No Results Posted as of Jun 3, 2014