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

September 30, 2013
September 17, 2014
March 2014
October 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01963546 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effects of Different Types of Anesthesia on Stress Response in Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus
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

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diabetes
  • Stress
  • Anesthesia
  • Other: different types of anesthesia
  • 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.
  • Intravenous anesthesia
    We use total intravenous anesthesia to assess the stress response.
    Intervention: Other: different types of anesthesia
  • Intravenous and Inhalation anesthesia
    We use intravenous and inhalation anesthesia during the surgery.
    Intervention: Other: different types of anesthesia
  • Inhalation anesthesia
    We use inhalation anesthesia during the surgery.
    Intervention: 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).

    Intervention: Drug: Dexmedetomidine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
October 2015
October 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Qie wen bin, Master +8613729848200 qwenbin@outlook.com
China
 
NCT01963546
WQie
Yes
Wenbin Qie, Guangzhou General Hospital of Guangzhou Military Command
Guangzhou General Hospital of Guangzhou Military Command
Not Provided
Principal Investigator: Tu wei feng, Postdoctoral The General Hospital Of Guangzhou Military Command
Guangzhou General Hospital of Guangzhou Military Command
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP