Effects of Different Types of Anesthesia on Stress Response in Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2013
CompletedFirst Posted
Study publicly available on registry
October 16, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedSeptember 18, 2014
January 1, 2014
1.6 years
September 30, 2013
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Vital Signs
during surgery
Study Arms (4)
Intravenous anesthesia
OTHERWe use total intravenous anesthesia to assess the stress response.
Intravenous and Inhalation anesthesia
OTHERWe use intravenous and inhalation anesthesia during the surgery.
Inhalation anesthesia
OTHERWe use inhalation anesthesia during the surgery.
Dexmedetomidine
EXPERIMENTALthe 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists（ASA）Ⅰ \~ Ⅱpatients
- Type 2 Diabetes Mellitus patient undergoing Laparoscopic Gastric Bypass surgery
- between 18 and 60 years of age
You may not qualify if:
- A history of cardiopulmonary disease, liver and kidney dysfunction, abnormal coagulation
- Thyroid disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The General Hospital Of Guangzhou Military Command
Guangzhou, Guangdong, 510000, China
Related 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.
PMID: 24040483BACKGROUNDDell'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.
PMID: 23743557BACKGROUNDEzhevskaya 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.
PMID: 23514874BACKGROUNDHadimioglu 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.
PMID: 23195004BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tu wei feng, Postdoctoral
The General Hospital Of Guangzhou Military Command
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Effects of Different Types of Anesthesia on Stress Response in Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus
Study Record Dates
First Submitted
September 30, 2013
First Posted
October 16, 2013
Study Start
March 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
September 18, 2014
Record last verified: 2014-01