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Effects of Different Types of Anesthesia on Stress Response in Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus

Primary Purpose

Diabetes, Stress, Anesthesia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
different types of anesthesia
Dexmedetomidine
Sponsored by
Guangzhou General Hospital of Guangzhou Military Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring diabetic, laparoscopic gastric bypass surgery, stress response, anesthesia, dexmedetomidine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists(ASA)Ⅰ ~ Ⅱpatients
  • Type 2 Diabetes Mellitus patient undergoing Laparoscopic Gastric Bypass surgery
  • between 18 and 60 years of age

Exclusion Criteria:

  • A history of cardiopulmonary disease, liver and kidney dysfunction, abnormal coagulation
  • Thyroid disease

Sites / Locations

  • The General Hospital Of Guangzhou Military CommandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Experimental

Arm Label

Intravenous anesthesia

Intravenous and Inhalation anesthesia

Inhalation anesthesia

Dexmedetomidine

Arm Description

We use total intravenous anesthesia to assess the stress response.

We use intravenous and inhalation anesthesia during the surgery.

We use inhalation anesthesia during the surgery.

the effect of dexmedetomidine on the stress responses generated by patients with diabetic given gastric-bypass surgery : Group A group given the best anesthetic technique from preliminary work + dexmedetomidine Dexmedetomidine as a inducer was given intravenous infusion loading dose 1.0μg/kg for 10min, maintained intravenous infusion by 0.4μg/kg/h. Group B group given the best anesthesia method from preliminary work(not using dexmedetomidine).

Outcomes

Primary Outcome Measures

Stress Indicators
We use different anesthesia method to assess the stress indicators,aiming to choose an apposite anesthesia to reduce stress response in laparoscopic gastric bypass for type 2 diabetes mellitus.The stress indicators include Tumor Necrosis Factor-α,Interleukin-10,Interleukin-6,C-peptide,Cortisol,Insulin and Adrenocorticotropic hormone.

Secondary Outcome Measures

Vital Signs
We record blood pressure, heart rate, end-tidal carbon dioxide,mean arterial pressure at the time of intubation and 45min,90min when the surgery start.

Full Information

First Posted
September 30, 2013
Last Updated
September 17, 2014
Sponsor
Guangzhou General Hospital of Guangzhou Military Command
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1. Study Identification

Unique Protocol Identification Number
NCT01963546
Brief Title
Effects of Different Types of Anesthesia on Stress Response in Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus
Official Title
Effects of Different Types of Anesthesia on Stress Response in Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus and the Effect of Dexmedetomidine on the Stress Response in Patients With Diabetic Undergoing Gastric-bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou General Hospital of Guangzhou Military Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
General anesthesia can be considered as a combination of hypnosis, antinociception and immobility. Explore the effect of three kinds of anesthesia,that is the total intravenous anesthesia, inhalation anesthesia and inhalation and intravenous anesthesia on stress reactions generated by patients with diabetes conducted gastric - bypass surgery , and choose a best way from three kinds of anesthesia to control stress reaction of diabetics. After selecting the appropriate anesthesia method, assess the effect of dexmedetomidine on controlling stress response from diabetics undergoing laparoscopic gastric-bypass surgical.
Detailed Description
Research content and indicators Preparation of serum: 3ml of blood were taken before induction of anesthesia (after entering the operating room), surgery began 1h, surgery began 2h, 24h after surgery, and placed at dry tube, centrifuged for 10min at 3000g after placing at room temperature for 2h , the resulting supernatant was subpassaged in tube, stored at -20℃ until analysis. Indicators to detect in serum contained Tumor Necrosis Factor-α, Interleukin-6, Interleukin-10, plasma glucose, cortisol,insulin and c-peptide. Record the vital signs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Stress, Anesthesia
Keywords
diabetic, laparoscopic gastric bypass surgery, stress response, anesthesia, dexmedetomidine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous anesthesia
Arm Type
Other
Arm Description
We use total intravenous anesthesia to assess the stress response.
Arm Title
Intravenous and Inhalation anesthesia
Arm Type
Other
Arm Description
We use intravenous and inhalation anesthesia during the surgery.
Arm Title
Inhalation anesthesia
Arm Type
Other
Arm Description
We use inhalation anesthesia during the surgery.
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
the effect of dexmedetomidine on the stress responses generated by patients with diabetic given gastric-bypass surgery : Group A group given the best anesthetic technique from preliminary work + dexmedetomidine Dexmedetomidine as a inducer was given intravenous infusion loading dose 1.0μg/kg for 10min, maintained intravenous infusion by 0.4μg/kg/h. Group B group given the best anesthesia method from preliminary work(not using dexmedetomidine).
Intervention Type
Other
Intervention Name(s)
different types of anesthesia
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
After selecting the appropriate anesthesia method, assess the effect of dexmedetomidine on controlling stress response from diabetics undergoing laparoscopic gastric-bypass surgical.The stress indicators are the same as described above.
Primary Outcome Measure Information:
Title
Stress Indicators
Description
We use different anesthesia method to assess the stress indicators,aiming to choose an apposite anesthesia to reduce stress response in laparoscopic gastric bypass for type 2 diabetes mellitus.The stress indicators include Tumor Necrosis Factor-α,Interleukin-10,Interleukin-6,C-peptide,Cortisol,Insulin and Adrenocorticotropic hormone.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Vital Signs
Description
We record blood pressure, heart rate, end-tidal carbon dioxide,mean arterial pressure at the time of intubation and 45min,90min when the surgery start.
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists(ASA)Ⅰ ~ Ⅱpatients Type 2 Diabetes Mellitus patient undergoing Laparoscopic Gastric Bypass surgery between 18 and 60 years of age Exclusion Criteria: A history of cardiopulmonary disease, liver and kidney dysfunction, abnormal coagulation Thyroid disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qie wen bin, Master
Phone
+8613729848200
Email
qwenbin@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tu wei feng, Postdoctoral
Organizational Affiliation
The General Hospital Of Guangzhou Military Command
Official's Role
Principal Investigator
Facility Information:
Facility Name
The General Hospital Of Guangzhou Military Command
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tu wei feng, Postdoctoral
Phone
+86020-86653504
Email
wftuyx02@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24040483
Citation
Cheng YC, Cheng XB, Li XJ, Wang FZ, Li ZK. Combined general and regional anesthesia and effects on immune function in patients with benign ovarian tumors treated by laparoscopic therapy. Int J Clin Exp Med. 2013 Sep 1;6(8):716-9. eCollection 2013.
Results Reference
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PubMed Identifier
23743557
Citation
Dell'Aquila AM, Ellger B. Perioperative glycemic control: what is worth the effort? Curr Opin Anaesthesiol. 2013 Aug;26(4):438-43. doi: 10.1097/ACO.0b013e328362d16a.
Results Reference
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PubMed Identifier
23514874
Citation
Ezhevskaya AA, Mlyavykh SG, Anderson DG. Effects of continuous epidural anesthesia and postoperative epidural analgesia on pain management and stress response in patients undergoing major spinal surgery. Spine (Phila Pa 1976). 2013 Jul 1;38(15):1324-30. doi: 10.1097/BRS.0b013e318290ff26.
Results Reference
background
PubMed Identifier
23195004
Citation
Hadimioglu N, Ulugol H, Akbas H, Coskunfirat N, Ertug Z, Dinckan A. Combination of epidural anesthesia and general anesthesia attenuates stress response to renal transplantation surgery. Transplant Proc. 2012 Dec;44(10):2949-54. doi: 10.1016/j.transproceed.2012.08.004.
Results Reference
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Effects of Different Types of Anesthesia on Stress Response in Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus

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