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

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery
• Intervention / Treatment: Procedure: Anesthesia

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 2 days after surgery

Collaborators and Investigators

• Sponsor: Gabriele Baldini, MD, MSc, Assistant Professor
• Investigators: Principal Investigator: Francesco Donatelli, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 29, 2012
• First Submitted That Met QC Criteria: November 29, 2012
• First Posted (Estimate): December 3, 2012

Study Record Updates

• Last Update Posted (Actual): October 10, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 11-263-SDR