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

Primary Purpose

Colorectal Surgery

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Anesthesia
Sponsored by
Gabriele Baldini, MD, MSc, Assistant Professor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

General Anesthesia

Epidural Anesthesia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hyperinsulinemic-euglycemic clamp
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.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2012
Last Updated
October 6, 2017
Sponsor
Gabriele Baldini, MD, MSc, Assistant Professor
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1. Study Identification

Unique Protocol Identification Number
NCT01739413
Brief Title
Effect of Anesthesia on Insulin Secretion in Patients With Preoperative Decreased Insulin Sensitivity
Official Title
Effect of Epidural Anesthesia and Analgesia on Insulin Secretion in Patients With Preoperative Decreased Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gabriele Baldini, MD, MSc, Assistant Professor

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. To understand which measures of postoperative recovery are sensitive to the restoration of insulin secretion in this particular group of patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General Anesthesia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Epidural Anesthesia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Anesthesia
Intervention Description
Patients will be randomized to receive either epidural or general anesthesia for pain management throughout their surgery.
Primary Outcome Measure Information:
Title
Hyperinsulinemic-euglycemic clamp
Description
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.
Time Frame
up to 2 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Donatelli, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21880795
Citation
Donatelli F, Corbella D, Di Nicola M, Carli F, Lorini L, Fumagalli R, Biolo G. Preoperative insulin resistance and the impact of feeding on postoperative protein balance: a stable isotope study. J Clin Endocrinol Metab. 2011 Nov;96(11):E1789-97. doi: 10.1210/jc.2011-0549. Epub 2011 Aug 31.
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Effect of Anesthesia on Insulin Secretion in Patients With Preoperative Decreased Insulin Sensitivity

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