Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01739413
Enrollment
30
Registered
2012-12-03
Start date
2012-11-30
Completion date
2015-11-30
Last updated
2017-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Surgery

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

Interventions

PROCEDUREAnesthesia

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

Sponsors

Gabriele Baldini, MD, MSc, Assistant Professor
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hyperinsulinemic-euglycemic clampup to 2 days after surgeryThe 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026