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

NCT ID: NCT02154074

Last Updated: 2014-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

Brief Summary

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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

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Conditions

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Perioperative Blood Glucose and Insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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N1 group: Isoflurane & saline

for normal patients: inhale Isoflurane + the same volume of saline during operation

Group Type ACTIVE_COMPARATOR

general anesthesia induction

Intervention Type DRUG

general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg

Isoflurane

Intervention Type DRUG

inhale Isoflurane 1.5MAC

normal saline

Intervention Type DRUG

the same volume of saline + Isoflurane during operation

N2 group: Isoflurane & Dexmedetomidine

for normal patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation

Group Type EXPERIMENTAL

general anesthesia induction

Intervention Type DRUG

general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg

Isoflurane

Intervention Type DRUG

inhale Isoflurane 1.5MAC

Dexmedetomidine

Intervention Type DRUG

anesthesia induction period: intravenous pumping Dexmedetomidine 4ug/Kg/h; after 10 minutes,turn to 0.4ug/Kg/h.

D1 group: Isoflurane & saline

for diabetes patients: inhale Isoflurane + the same volume of saline during operation

Group Type ACTIVE_COMPARATOR

general anesthesia induction

Intervention Type DRUG

general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg

Isoflurane

Intervention Type DRUG

inhale Isoflurane 1.5MAC

normal saline

Intervention Type DRUG

the same volume of saline + Isoflurane during operation

D2 group: Isoflurane & Dexmedetomidi

for diabetes patients: inhale Isoflurane + intravenous pumping Dexmedetomidine during operation

Group Type EXPERIMENTAL

general anesthesia induction

Intervention Type DRUG

general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg

Isoflurane

Intervention Type DRUG

inhale Isoflurane 1.5MAC

Dexmedetomidine

Intervention Type DRUG

anesthesia induction period: intravenous pumping Dexmedetomidine 4ug/Kg/h; after 10 minutes,turn to 0.4ug/Kg/h.

Interventions

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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

Intervention Type DRUG

Isoflurane

inhale Isoflurane 1.5MAC

Intervention Type DRUG

Dexmedetomidine

anesthesia induction period: intravenous pumping Dexmedetomidine 4ug/Kg/h; after 10 minutes,turn to 0.4ug/Kg/h.

Intervention Type DRUG

normal saline

the same volume of saline + Isoflurane during operation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SecondXianJiaotongU

Xi’an, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongtao Liu

Role: CONTACT

13572225310

Facility Contacts

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Hongtao Liu

Role: primary

13572225310

Other Identifiers

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Dexmedetomidine 20140527

Identifier Type: -

Identifier Source: org_study_id

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