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

Not Applicable

• Conditions: Stress; Anesthesia; Diabetes
• Interventions: Other: different types of anesthesia; Drug: Dexmedetomidine

• Registration Number: NCT01963546
• Lead Sponsor: Guangzhou General Hospital of Guangzhou Military Command

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.

Study Timeline

• Study First Submitted: 2013-09-30
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-16
• Status Verified: 2014-01
• Study Start: 2014-03
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous and Inhalation anesthesia	different types of anesthesia	We use intravenous and inhalation anesthesia during the surgery.
Inhalation anesthesia	different types of anesthesia	We use inhalation anesthesia during the surgery.
Intravenous anesthesia	different types of anesthesia	We use total intravenous anesthesia to assess the stress response.
Dexmedetomidine	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).

Primary Outcome Measures

Name	Time	Method
Stress Indicators	72 hours	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.

Secondary Outcome Measures

Name	Time	Method
Vital Signs	during surgery	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.

Trial Locations

Locations (1)

The General Hospital Of Guangzhou Military Command; 🇨🇳 Guangzhou, Guangdong, China