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

NCT ID: NCT01739413

Last Updated: 2017-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-11-30

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

Conditions

Colorectal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

General Anesthesia

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.

Group Type: ACTIVE_COMPARATOR

Anesthesia

Intervention Type: PROCEDURE

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

Epidural Anesthesia

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.

Group Type: EXPERIMENTAL

Anesthesia

Intervention Type: PROCEDURE

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

Interventions

Anesthesia

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gabriele Baldini, MD, MSc, Assistant Professor

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Baldini, MD, MSc, Assistant Professor

Assitant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Francesco Donatelli, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 21880795 (View on PubMed)

Other Identifiers

11-263-SDR

Identifier Type: -

Identifier Source: org_study_id