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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01963546
• Other study ID #: WQie
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2013
• Last updated: September 17, 2014
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2014
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: Qie wen bin, Master
• Phone: +8613729848200
• Email: qwenbin[@]outlook.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists(ASA)? ~ ?patients

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia
• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Stress

Intervention

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.

Locations

Country	Name	City	State
China	The General Hospital Of Guangzhou Military Command	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-a,Interleukin-10,Interleukin-6,C-peptide,Cortisol,Insulin and Adrenocorticotropic hormone.	72 hours	No
Secondary	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.	during surgery	No