Clinical trial NCT01963546: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Stress
Anesthesia
Keywords: diabetic
laparoscopic gastric bypass surgery
stress response
anesthesia
dexmedetomidine
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: Stress Indicators
timeFrame: 72 hours
Secondary outcomes:
measure: Vital Signs
timeFrame: during surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The General Hospital Of Guangzhou Military Command
state: Guangdong
Study officials:
affiliation: The General Hospital Of Guangzhou Military Command
name: Tu wei feng, Postdoctoral
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.