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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Guangzhou General Hospital of Guangzhou Military Command
Sponsor:
Information provided by (Responsible Party):
Wenbin Qie, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier:
NCT01963546
First received: September 30, 2013
Last updated: September 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Diabetes
Stress
Anesthesia
Other: different types of anesthesia
Drug: Dexmedetomidine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Guangzhou General Hospital of Guangzhou Military Command:

Primary Outcome Measures:
  • Stress Indicators [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: during surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: March 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intravenous anesthesia
We use total intravenous anesthesia to assess the stress response.
Other: different types of anesthesia
Intravenous and Inhalation anesthesia
We use intravenous and inhalation anesthesia during the surgery.
Other: different types of anesthesia
Inhalation anesthesia
We use inhalation anesthesia during the surgery.
Other: different types of anesthesia
Experimental: Dexmedetomidine

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).

Drug: Dexmedetomidine
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.

Detailed Description:

Research content and indicators

  1. 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.
  2. Indicators to detect in serum contained Tumor Necrosis Factor-α, Interleukin-6, Interleukin-10, plasma glucose, cortisol,insulin and c-peptide.
  3. Record the vital signs.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963546

Contacts
Contact: Qie wen bin, Master +8613729848200 qwenbin@outlook.com

Locations
China, Guangdong
The General Hospital Of Guangzhou Military Command Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Tu wei feng, Postdoctoral    +86020-86653504    wftuyx02@163.com   
Sponsors and Collaborators
Guangzhou General Hospital of Guangzhou Military Command
Investigators
Principal Investigator: Tu wei feng, Postdoctoral The General Hospital Of Guangzhou Military Command
  More Information

Publications:
Responsible Party: Wenbin Qie, Effects of Different Types of Anesthesia on Stress Response in Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT01963546     History of Changes
Other Study ID Numbers: WQie
Study First Received: September 30, 2013
Last Updated: September 17, 2014
Health Authority: China: Ethics Committee

Keywords provided by Guangzhou General Hospital of Guangzhou Military Command:
diabetic
laparoscopic gastric bypass surgery
stress response
anesthesia
dexmedetomidine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Anesthetics
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014