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OpenTrials
Completed

NCT Number: NCT01739413

Effect of Anesthesia 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

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Key information

Conditions

Colorectal Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anesthesia

Procedure

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

Primary outcomes

  1. Hyperinsulinemic-euglycemic clamp

    Time frame: up to 2 days after surgery

    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.

Sponsors and collaborators

Lead sponsor

Gabriele Baldini, MD, MSc, Assistant Professor

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2012
Registry last updated
Oct 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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