Oral Peri-operative TIming of Metformin (or) Salsalate to Improve Non-cardiac Surgery Glucose Control

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: In surgical patients with type 2 diabetes, taking either metformin or salsalate on the morning of surgery will reduce the incidence of hyperglycemia, inflammation and even surgical site infections, without any obvious patient risk relative to patients given a placebo control.

Anesthesia and surgery induce a number of metabolic disturbances, particularly among patients with type 2 diabetes (T2D). This includes altered glucose metabolism and hyperglycemia, which is associated with significant morbidity and mortality, including an increase in surgical site infections (SSI). Although insulin protocols can reduce blood glucose levels in hyperglycemic surgical patients, leading to reduced SSI, this has caused severe hypoglycemia in a number of patients. Instead, the use of simple and effective interventions, such as continuing metformin on the day of surgery, could represent an important step toward reducing the incidence of these morbid outcomes while improving glucose control. Alternatively, salsalate, a non-acetylated dimer of salicylic acid, has also emerged as a novel glucose-lowering medication that also possesses important anti-pyretic and anti-inflammatory properties and could prove equally effective.These refinements may also reduce SSI and inflammation. If the proposed pilot trial, to continue metformin, or take salsalate, peri-operatively, is as safe and easy as the investigators anticipate it will allow for the planning of a future definitive randomized clinical trial. The aims of this pilot trial are to assess the feasibility of safely continuing metformin, or taking salsalate on the day of surgery, with the goal of reducing the incidence of hyperglycemic events. This includes assessing our ability to recruit patients, adhere to the proposed study protocol, assess workload,and measure the desired outcomes, all of which are crucial for the planning of a subsequent clinical trial.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Treatments: Metformin; Salicylsalicylic acid; Sodium Salicylate

Criteria

Inclusion Criteria:

• Elective surgical patients requiring a general anesthetic at HHS requiring at least an overnight admission;

• Using metformin regularly for control of T2D;

• American Society of Anesthesiologists (ASA) physical classification I, II and III;

• Less than 1000 mL of blood loss is expected.

Exclusion Criteria:

• Procedures for which non-steroidal anti-inflammatory drugs are contraindicated;

• Diagnosis of renal failure (estimated glomerular filtration rate <60 mL/min/1.73m2);

• Liver failure;

• Previous episodes of congestive heart failure;

• Severe hypoglycemia in the past year;

• Conditions masking hypoglycemia (e.g. autonomic neuropathy);

• Low random blood glucose during pre-screening (≤4.0 mmol/L);

• Received contrast within 48h prior to, or during, surgery.