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

Gabriele Baldini, MD, MSc, Assistant Professor

Status: Completed

Conditions: Colorectal Surgery

Treatments: Procedure: Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01739413

11-263-SDR

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

General Anesthesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Anesthesia

Epidural Anesthesia

Experimental group

Description:

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.

Treatment:

Procedure: Anesthesia