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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01739413
First received: November 29, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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 Intervention
Colorectal Surgery
Procedure: Anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Epidural Anesthesia and Analgesia on Insulin Secretion in Patients With Preoperative Decreased Insulin Sensitivity

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Hyperinsulinemic-euglycemic clamp [ Time Frame: up to 2 days after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Excluded will be persons with American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions (e.g.dementia, disabling orthopedic and 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, and 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739413

Contacts
Contact: Francesco Donatelli, MD 514-934-1934 ext 43794 fdonatelli@inwind.it
Contact: Chelsia Gillis, PDt 514-934-1934 ext 45394 chelsia.gillis@mail.mcgill.ca

Locations
Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Francesco Donatelli, MD    (514) 934-1934 ext 43794    fdonatelli@inwind.it   
Contact: Chelsia Gillis, PDt    (514) 934-1934 ext 45394    chelsia.gillis@mail.mcgill.ca   
Principal Investigator: Francesco Donatelli, MD         
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Francesco Donatelli, MD McGill University Health Center
  More Information

Publications:
Responsible Party: McGill University Health Center
ClinicalTrials.gov Identifier: NCT01739413     History of Changes
Other Study ID Numbers: 11-263-SDR
Study First Received: November 29, 2012
Last Updated: November 29, 2012
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014