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

Colorectal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739413
• Other study ID #: 11-263-SDR
• Status: Completed
• Phase: N/A
• First received: November 29, 2012
• Last updated: October 6, 2017
• Start date: November 2012
• Est. completion date: November 2015

Study information

• Verified date: October 2017
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Surgery
• Insulin Resistance

Intervention

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

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Gabriele Baldini, MD, MSc, Assistant Professor

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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