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Per interim analysis, for futility.
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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.
The perioperative period is characterized by an intense inflammatory response marked by elevated concentrations of inflammatory markers like C-Reactive Protein (CRP). This response has been linked to increased perioperative morbidity and mortality. Available evidence suggests that blunting the inflammatory response to surgical trauma might improve perioperative outcomes. The putative benefits from blunting the surgical stress response are likely to be greatest in high-risk patients such as those having major non-cardiac surgery. We will study three interventions potentially modulating perioperative inflammation, corticosteroids, tight glucose control and light anesthesia and their effects on major morbidity and mortality resulting from major non-cardiac surgery.
Steroids are the most powerful routinely available anti-inflammatory drugs. They decrease perioperative concentrations of inflammatory markers and improve outcomes after cardiac and abdominal surgery.
Poorly controlled blood glucose worsens the inflammatory response to surgery. Hyperglycemia impairs wound healing, increases infection risk, increases overall hospital mortality, increases the risk of perioperative renal failure, and augments transfusion requirements. Treatment of hyperglycemia has been shown to improve outcomes and decrease mortality in cardiac patients. Also in critically ill patients, it decreased inflammatory markers, overall hospital mortality by 34%, blood stream infections by 46%, and acute renal failure by 41%.
Cumulative deep hypnotic time is associated with increased one-year all-cause mortality, possibly through aggravation of the inflammatory response to surgery. In contrast, avoidance of deep anesthesia appears to reduce postoperative CRP levels, the risk of nausea and vomiting, as well as postoperative hemodynamic, respiratory and infectious complications.
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, we 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Glucose Control, Dexamethasone, light anesthesia | Active Comparator |
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| Intensive Glucose Control, Dexamethasone, Deep anesthesia | Active Comparator |
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| Intensive Glucose Control, placebo, Light anesthesia | Active Comparator |
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| Conventional Glucose Control, Dexamethasone, Light anesthesia | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone Sodium Sulfate | Drug | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Major Perioperative Morbidity | Our primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality. | 30 day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 1 Year Mortality | All-cause mortality | 1 year after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Basem Abdelmalak, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37526194 | Derived | Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3. | |
| 26897443 | Derived | Abdelmalak BB, Duncan AE, Bonilla A, Yang D, Parra-Sanchez I, Fergany A, Irefin SA, Sessler DI. The intraoperative glycemic response to intravenous insulin during noncardiac surgery: a subanalysis of the DeLiT randomized trial. J Clin Anesth. 2016 Mar;29:19-29. doi: 10.1016/j.jclinane.2015.10.005. Epub 2016 Feb 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Glucose Control, Dexamethasone, Light Anesthesia |
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 Insulin: Insulin to maintain blood glucose 80-110 mg/dl. anesthesia management: Light anesthesia to maintain BIS about 55 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Intensive Glucose Control, Placebo, Deep anesthesia | Active Comparator |
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| Conventional Glucose Control, Dexamethasone, Deep anesthesia | Active Comparator |
|
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| Conventional Glucose Control, Placebo, Light anesthesia | Active Comparator |
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| Conventional Glucose Control, Placebo, Deep anesthesia | Placebo Comparator |
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| Insulin | Drug | Insulin to maintain blood glucose 80-110 mg/dl. |
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| anesthesia management | Drug | Light anesthesia to maintain BIS about 55 |
|
| Dexamethasone - placebo | Other | 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 |
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| Insulin - Placebo | Other | Insulin to maintain blood glucose 180-200 mg/dl. |
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| Anesthesia management -Placebo | Other | Deep anesthesia to maintain BIS about 35 |
|
| 23539236 | Derived | Abdelmalak BB, Bonilla A, Mascha EJ, Maheshwari A, Tang WH, You J, Ramachandran M, Kirkova Y, Clair D, Walsh RM, Kurz A, Sessler DI. Dexamethasone, light anaesthesia, and tight glucose control (DeLiT) randomized controlled trial. Br J Anaesth. 2013 Aug;111(2):209-21. doi: 10.1093/bja/aet050. Epub 2013 Mar 28. |
| 21598057 | Derived | Abdelmalak B, Maheshwari A, Kovaci B, Mascha EJ, Cywinski JB, Kurz A, Kashyap VS, Sessler DI. Validation of the DeLiT Trial intravenous insulin infusion algorithm for intraoperative glucose control in noncardiac surgery: a randomized controlled trial. Can J Anaesth. 2011 Jul;58(7):606-616. doi: 10.1007/s12630-011-9509-3. Epub 2011 May 20. |
| FG001 | Intensive Glucose Control, Dexamethasone, Deep Anesthesia |
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 Insulin: Insulin to maintain blood glucose 80-110 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
| FG002 | Intensive Glucose Control, Placebo, Light Anesthesia |
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 anesthesia management: Light anesthesia to maintain BIS about 55 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. |
| FG003 | Conventional Glucose Control, Dexamethasone, Light Anesthesia |
Insulin: Insulin to maintain blood glucose 80-110 mg/dl. anesthesia management: Light anesthesia to maintain BIS about 55 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 |
| FG004 | Intensive Glucose Control, Placebo, Deep Anesthesia |
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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
| FG005 | Conventional Glucose Control, Dexamethasone, Deep Anesthesia |
Insulin: Insulin to maintain blood glucose 80-110 mg/dl. 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 Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
| FG006 | Conventional Glucose Control, Placebo, Light Anesthesia |
anesthesia management: Light anesthesia to maintain BIS about 55 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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. |
| FG007 | Conventional Glucose Control, Placebo, Deep Anesthesia |
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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Glucose Control, Dexamethasone, Light Anesthesia |
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 Insulin: Insulin to maintain blood glucose 80-110 mg/dl. anesthesia management: Light anesthesia to maintain BIS about 55 |
| BG001 | Intensive Glucose Control, Dexamethasone, Deep Anesthesia |
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 Insulin: Insulin to maintain blood glucose 80-110 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
| BG002 | Intensive Glucose Control, Placebo, Light Anesthesia |
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 anesthesia management: Light anesthesia to maintain BIS about 55 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. |
| BG003 | Conventional Glucose Control, Dexamethasone, Light Anesthesia |
Insulin: Insulin to maintain blood glucose 80-110 mg/dl. anesthesia management: Light anesthesia to maintain BIS about 55 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 |
| BG004 | Intensive Glucose Control, Placebo, Deep Anesthesia |
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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
| BG005 | Conventional Glucose Control, Dexamethasone, Deep Anesthesia |
Insulin: Insulin to maintain blood glucose 80-110 mg/dl. 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 Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
| BG006 | Conventional Glucose Control, Placebo, Light Anesthesia |
anesthesia management: Light anesthesia to maintain BIS about 55 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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. |
| BG007 | Conventional Glucose Control, Placebo, Deep Anesthesia |
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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Perioperative Morbidity | Our primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality. | Posted | Count of Participants | Participants | 30 day after surgery |
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| Secondary | 1 Year Mortality | All-cause mortality | Posted | Count of Participants | Participants | 1 year after surgery |
|
1 year for all-cause mortality 30-day for major complications
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intensive Glucose Control, Dexamethasone, Light Anesthesia |
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 Insulin: Insulin to maintain blood glucose 80-110 mg/dl. anesthesia management: Light anesthesia to maintain BIS about 55 | 1 | 52 | 10 | 52 | 15 | 52 |
| EG001 | Intensive Glucose Control, Dexamethasone, Deep Anesthesia |
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 Insulin: Insulin to maintain blood glucose 80-110 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 | 7 | 51 | 10 | 51 | 25 | 51 |
| EG002 | Intensive Glucose Control, Placebo, Light Anesthesia |
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 anesthesia management: Light anesthesia to maintain BIS about 55 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. | 9 | 47 | 8 | 47 | 20 | 47 |
| EG003 | Conventional Glucose Control, Dexamethasone, Light Anesthesia |
Insulin: Insulin to maintain blood glucose 80-110 mg/dl. anesthesia management: Light anesthesia to maintain BIS about 55 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 | 7 | 46 | 9 | 46 | 17 | 46 |
| EG004 | Intensive Glucose Control, Placebo, Deep Anesthesia |
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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 | 7 | 46 | 10 | 46 | 22 | 46 |
| EG005 | Conventional Glucose Control, Dexamethasone, Deep Anesthesia |
Insulin: Insulin to maintain blood glucose 80-110 mg/dl. 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 Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 | 7 | 44 | 8 | 44 | 21 | 44 |
| EG006 | Conventional Glucose Control, Placebo, Light Anesthesia |
anesthesia management: Light anesthesia to maintain BIS about 55 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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. | 5 | 49 | 11 | 49 | 20 | 49 |
| EG007 | Conventional Glucose Control, Placebo, Deep Anesthesia |
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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 | 2 | 46 | 9 | 46 | 24 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 30-day major surgical complications | Injury, poisoning and procedural complications | Non-systematic Assessment | sepsis, surgical site infection, MI, heart failure, stroke, unstable ventricular arrhythmias,PE, pneumonia, respiratory failure, renal failure, large pleural/peritoneal effusions, bleeding, healing complications, vascular graft thrombosis, mortality |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 30-day minor surgical complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Sessler, MD | Cleveland clinic | 216-445-4900 | sesseld@ccf.org |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C016356 | dexamethasone sulfate ester |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
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| African American |
|
Compare 4 arms with Dexamethasone vs. 4 arms with Placebo |
| Regression, Logistic |
| 0.87 |
| Odds Ratio (OR) |
| 0.96 |
| 2-Sided |
| 99.6 |
| 0.45 |
| 2 |
| Superiority |
| Compare 4 arms with light anesthesia vs. 4 arms with deep anesthesia | Regression, Logistic | 0.90 | Odds Ratio (OR) | 1 | 2-Sided | 99.6 | 0.49 | 2.2 | Superiority |
| OG002 | Intensive Glucose Control, Placebo, Light Anesthesia |
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 anesthesia management: Light anesthesia to maintain BIS about 55 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. |
| OG003 | Conventional Glucose Control, Dexamethasone, Light Anesthesia |
Insulin: Insulin to maintain blood glucose 80-110 mg/dl. anesthesia management: Light anesthesia to maintain BIS about 55 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 |
| OG004 | Intensive Glucose Control, Placebo, Deep Anesthesia |
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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
| OG005 | Conventional Glucose Control, Dexamethasone, Deep Anesthesia |
Insulin: Insulin to maintain blood glucose 80-110 mg/dl. 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 Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
| OG006 | Conventional Glucose Control, Placebo, Light Anesthesia |
anesthesia management: Light anesthesia to maintain BIS about 55 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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. |
| OG007 | Conventional Glucose Control, Placebo, Deep Anesthesia |
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 Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl. Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35 |
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