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))

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.

Conditions

• Inflammation
• Perioperative Morbidity

Interventions

DRUG

Dexamethasone Sodium Sulfate

8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning

DRUG

Insulin

Insulin to maintain blood glucose 80-110 mg/dl.

DRUG

anesthesia management

Light anesthesia to maintain BIS about 55

OTHER

Dexamethasone - placebo

8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning

OTHER

Insulin - Placebo

Insulin to maintain blood glucose 180-200 mg/dl.

OTHER

Anesthesia management -Placebo

Deep anesthesia to maintain BIS about 35

Sponsors & Collaborators

• d sessler

  lead OTHER

Principal Investigators

• Basem Abdelmalak, MD · The Cleveland Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

40 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• United States

Study Locations