Clinical trial NCT01739413: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-12-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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.

Primary outcomes:
measure: Hyperinsulinemic-euglycemic clamp
timeFrame: up to 2 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Francesco Donatelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.