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.

Study Overview

• Status: Unknown
• Conditions: Diabetes; Stress; Anesthesia
• Intervention / Treatment: Other: different types of anesthesia; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The General Hospital Of Guangzhou Military Command
      • Contact: Tu wei feng, Postdoctoral; Phone Number: +86020-86653504; Email: wftuyx02@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intravenous anesthesia; We use total intravenous anesthesia to assess the stress response.	Other: different types of anesthesia
Other: Intravenous and Inhalation anesthesia; We use intravenous and inhalation anesthesia during the surgery.	Other: different types of anesthesia
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Guangzhou General Hospital of Guangzhou Military Command
• Investigators: Principal Investigator: Tu wei feng, Postdoctoral, The General Hospital Of Guangzhou Military Command

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): October 1, 2015
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: October 11, 2013
• First Posted (Estimate): October 16, 2013

Study Record Updates

• Last Update Posted (Estimate): September 18, 2014
• Last Update Submitted That Met QC Criteria: September 17, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: anesthesia; dexmedetomidine; stress response; diabetic; laparoscopic gastric bypass surgery
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: WQie