The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Non-cardiac Surgery (Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT Trial))

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Evidence thus suggests that steroid administration, tight glucose control, and avoidance of deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to surgery. Using a three-way factorial approach, the investigators thus propose to test the primary hypotheses that major perioperative morbidity is reduced by: 1) low-dose dexamethasone; 2) intensive perioperative glucose control; and 3) lighter anesthesia.

Secondary hypotheses include that each intervention reduces circulating concentrations of the inflammatory marker CRP, and that there is a correlation between C-reactive protein (CRP) and post-operative complications. Anesthetic sensitivity predicts major and minor complications, and delirium Other secondary hypotheses are that each intervention, reduces minor surgical complications, reduces postoperative nausea and vomiting (PONV), reduces postoperative delirium, speeds hospital discharge, improves quality of life (SF-12v2 Health Survey, Christensen's VAS fatigue score), and reduces all-cause one-year mortality.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: d sessler
• Treatments: Anesthetics; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Insulin; Insulin, Globin Zinc; Sodium sulfate

Criteria

Inclusion Criteria:

1. Age ≥40 years old.

2. Major non-cardiac surgical procedures scheduled to take ≥ two hours done under general anesthesia.

3. Written informed consent

Exclusion Criteria:

1. Recent intravenous or oral steroid therapy (within 30 days); inhaled steroids are permitted

2. Any contraindications to the proposed interventions

3. ASA Physical Status > 4

4. Non English speaking patients

5. Procedures done under regional anesthesia