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

NCT01739413 | Completed

• 1 other identifier: 11-263-SDR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

General Anesthesia

ACTIVE COMPARATOR

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

Epidural Anesthesia

EXPERIMENTAL

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

Interventions

Anesthesia PROCEDURE

Patients will be randomized to receive either epidural or general anesthesia for pain management throughout their surgery.

Epidural Anesthesia; General Anesthesia

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gabriele Baldini, MD, MSc, Assistant Professor: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

• 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.

  PMID: 21880795 BACKGROUND

MeSH Terms

Interventions

Anesthesia

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Francesco Donatelli, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 3, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 10, 2017

Record last verified: 2017-10

Locations

CA (1)