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Effect of Anesthesia on Insulin Secretion in Patients With Preoperative Decreased Insulin Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01739413
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Gabriele Baldini, MD, MSc, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:

Epidural anesthesia has been found to manipulate the hyperglycemic response to surgery. It is unclear, however, whether the preoperative metabolic status of the surgical patient plays a role in the degree of this hyperglycemic response. For instance, the presence of low insulin sensitivity before surgery could predispose the individual to an altered metabolic response after surgery. In this case, it would be appropriate to identify adequate interventions that attenuate the response to surgical stress and facilitate the recovery process.

The aims of this research projects are the following:

  1. To determine the extent in which epidural local anesthetics, initiated before surgery and continued after surgery, improves insulin secretion in patients with preoperative low insulin sensitivity.
  2. To understand which measures of postoperative recovery are sensitive to the restoration of insulin secretion in this particular group of patients

Condition or disease Intervention/treatment Phase
Colorectal Surgery Procedure: Anesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Epidural Anesthesia and Analgesia on Insulin Secretion in Patients With Preoperative Decreased Insulin Sensitivity
Study Start Date : November 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: General Anesthesia
Patients will receive general anesthesia alone followed by intravenous morphine for postoperative pain control. This techniques is safe and is standard procedure for colorectal surgery.
Procedure: Anesthesia
Patients will be randomized to receive either epidural or general anesthesia for pain management throughout their surgery.

Experimental: Epidural Anesthesia
Patients will receive general anesthesia plus epidural anesthesia followed by epidural analgesia for postoperative pain control. This techniques is safe and standard procedure for colorectal surgery.
Procedure: Anesthesia
Patients will be randomized to receive either epidural or general anesthesia for pain management throughout their surgery.




Primary Outcome Measures :
  1. Hyperinsulinemic-euglycemic clamp [ Time Frame: up to 2 days after surgery ]
    The Hyperinsulinemic-euglycemic clamp is the gold standard for measuring insulin sensitivity. Patients receive a 2 hour infusion of glucose and insulin, which is adjusted throughout the study period in order to maintain a blood glucose concentration at 5.5mmol/L. The test will take place one week before surgery and on the second postoperative day.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receiving elective resection of malignant, non metastatic, colorectal lesions

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) health status class 4-5
  • Dementia,neuromuscular disease, psychosis
  • Cardiac abnormalities
  • Severe end-organ disease such as cardiac failure (New York Heart Association classes I-IV)
  • Chronic obstructive pulmonary disease
  • Renal failure (creatinine > 1.5 mg/dl)
  • Hepatic failure (liver transaminases >50% over the normal range)
  • Diabetics with glycosylated hemoglobin > 6%
  • Steroid consumption longer than 30 days sepsis
  • Morbid obesity (body mass index >40)
  • Anemia (hematocrit < 30 %, haemoglobin <10g/dl, albumin < 25mg/dl).
  • Patients will be excluded if they have poor English or French comprehension.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739413


Locations
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Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Gabriele Baldini, MD, MSc, Assistant Professor
Investigators
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Principal Investigator: Francesco Donatelli, MD McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications:
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Responsible Party: Gabriele Baldini, MD, MSc, Assistant Professor, Assitant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01739413    
Other Study ID Numbers: 11-263-SDR
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Anesthetics
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Depressants