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| Name | Class |
|---|---|
| Mylan Inc. | INDUSTRY |
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This study evaluates the effect of using remifentanil during cardiopulmonary bypass surgery to supress the hyperglycemic response in perioperative period. Half of the participants will receive continuous intravenous remifentanil during surgery, while the other half will receive intermittent intravenous fentanyl during surgery. Intermittent intravenous fentanyl administration is this institution's standard of care.
Stress-induced hyperglycemia is a well-known phenomena that occurs during cardiopulmonary bypass surgery. Hyperglycemia increases the incidence of major adverse events and mortality in patients undergoing cardiac surgery.
Remifentanil, an ultra-short acting opioid analgesic, has been shown to reduce the stress response to cardiopulmonary bypass when compared to intermittent fentanyl and inhalation anesthesia. This in turn, will reduce the occurence of perioperative hyperglycemia, glycemic variability and insulin requirements in patients undergoing cardiac surgery.
NOTE;
Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016.
Primary outcome measure; Percentage of patients with two or more than two intraoperative blood glucose levels more than 180 mg% in both groups will be estimated and the difference in this parameter between the two groups will form the primary outcome measure of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil group | Experimental | Half of subjects enrolled will be randomized to the remifentanil group |
|
| Fentanyl group | Active Comparator | Half of subjects enrolled will be randomized to the fentanyl group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Glucose Values (More Than One ) > 180 mg% | Percentage of patients with two or more intraoperative blood glucose levels greater than 180 mg/dl. Percentage in both groups will be estimated, then the difference in this statistic will form the primary outcome measure of this study. (Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016) | Intraoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Requirement | Average dose of insulin (Units/ml) calculated for each group in the intraoperative period | Intraoperative period; Induction to end of surgery |
| Number of Blood Glucose Values > 180 mg% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathrivel Subramaniam, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16214532 | Background | Doenst T, Wijeysundera D, Karkouti K, Zechner C, Maganti M, Rao V, Borger MA. Hyperglycemia during cardiopulmonary bypass is an independent risk factor for mortality in patients undergoing cardiac surgery. J Thorac Cardiovasc Surg. 2005 Oct;130(4):1144. doi: 10.1016/j.jtcvs.2005.05.049. | |
| 20146874 | Background |
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No pre-assignment necessary for enrollment
The first subject was recruited 01-06-2016. The final subject was recruited 12-28-2016. All enrolled subjects were recruited at Presbyterian Hospital in Pittsburgh, Pennsylvania.
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| ID | Title | Description |
|---|---|---|
| FG000 | Remifentanil Group | Half of subjects enrolled will be randomized to the remifentanil group Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated. |
| FG001 | Fentanyl Group | Half of subjects enrolled will be randomized to the fentanyl group Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Remifentanil Group | Half of subjects enrolled will be randomized to the remifentanil group Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Blood Glucose Values (More Than One ) > 180 mg% | Percentage of patients with two or more intraoperative blood glucose levels greater than 180 mg/dl. Percentage in both groups will be estimated, then the difference in this statistic will form the primary outcome measure of this study. (Primary Outcome changed on 06/15/2015-Change Approved by University of Pittsburgh IRB on 06/22/2015- First patient enrolled January 2016) | Posted | Count of Participants | Participants | Intraoperative period |
|
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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 | Remifentanil Group | Half of subjects enrolled will be randomized to the remifentanil group Remifentanil: Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Pt readmitted for pneumonia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any postoperative complication | Surgical and medical procedures | Systematic Assessment | Sepsis, neurologic events, respiratory failure, thromboembolism, renal failure, cardiac arrest, rhythm abnormalities, multi-organ failures, readmissions, mortality. All data collected from Society of Thoracic Surgery (STS) database. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathirvel Subramaniam, MD, MPH | University of Pittsburgh | 412-647-5635 | subramaniamk@upmc.edu |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
|
| Fentanyl | Drug | Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery. |
|
Blood glucose values that exceed 180 mg% will be counted
| Intraoperative period, Induction to end of surgery |
| Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl) | Blood glucose measured every hour | Intraoperative period; Induction to end of surgery |
| Postoperative Blood Glucose | Mean and peak blood glucose levels postoperatively | From ICU Admission (After Surgery) Until 24 hours postoperatively |
| Total Postoperative Regular Insulin | Total units of regular insulin required post-operatively | From ICU Admission (After Surgery) Until 24 hours postoperatively |
| Intraoperative Pre-cardiopulmonary Bypass Hemodynamic Stability | Blood pressure (systolic, diastolic and mean), Heart rate every 5 minutes from induction of anesthesia till systemic heparinization before cardiopulmonary bypass | induction of anesthesia till systemic heparinization before cardiopulmonary bypass |
| Stress Hormone Levels-Cortisol (µg/dl) | Serum cortisol levels (measured as µg/dl) taken at: Prebypass, cardiopulmonary bypass (2 samples: at start of bypass and end of bypass), postbypass, ICU 8 hours postoperative period | Perioperative period (Intraoperatively and 8 hours postoperatively) |
| Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml) | Inflammatory mediator levels, Interleukin-1b (IL-1b), Interleukin 6 (IL-6) and Tumor Necrosis Factor Alpha (TNFa) (all measured in pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples:30 min start of bypass (CPB-30) and end of bypass (CPB-END), postbypass, ICU 8 hours postoperative period | Perioperative period (Intraoperatively and 8 hours postoperatively) |
| Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml) | Adreno-corticotrophic hormone (ACTH), Growth Hormone (GH) and Glucagon (measured as pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples: 30 mins after start of bypass (CPB 30) and end of bypass (CPB END), post-bypass and ICU 8 hours postoperative period | Perioperative period (Intraoperatively and 8 hours postoperatively) |
| Society of Thoracic Surgery Patient Outcomes | Postoperative outcomes collected from the Society of Thoracic Surgery (STS) database. 30 day Mortality (outcome 1) and 30 day Readmission (outcome 2) cerebral vascular accident(outcome 3), prolonged mechanical ventilation (outcome 4), renal failure (outcome 5), atrial fibrillation (outcome 6), cardiac arrest (outcome 7) | 30 day outcomes |
| Postoperative Pain | Pain scores; Every day 6 hour for 48 hours postoperative period | Every day 6 hour for 48 hours postoperative period |
| Emergence From Anesthesia | Time to extubation after completion of surgery in the operating room and intensive care unit | Immediate postoperative period until 30 days post-operatively |
| Wound Hyperalgesia | Von frey hair objective testing | 96 hours postoperatively |
| Development of Chronic Pain | Telephonic call Numeric pain scale; Scale is 0-10, with 10 being the highest pain. | 1, 3, 6 and 12 months after discharge from the hospital |
| Glycemic Variability | Coefficient of variation in blood glucose levels. Denotes how large the fluctuations in blood glucose are. Higher numbers indicate increased variation. | From the start of induction till 24 hours postoperatively |
| Ihn CH, Joo JD, Choi JW, Kim DW, Jeon YS, Kim YS, Jung HS, Kwon SY. Comparison of stress hormone response, interleukin-6 and anaesthetic characteristics of two anaesthetic techniques: volatile induction and maintenance of anaesthesia using sevoflurane versus total intravenous anaesthesia using propofol and remifentanil. J Int Med Res. 2009 Nov-Dec;37(6):1760-71. doi: 10.1177/147323000903700612. |
| 24445629 | Background | Subramaniam B, Lerner A, Novack V, Khabbaz K, Paryente-Wiesmann M, Hess P, Talmor D. Increased glycemic variability in patients with elevated preoperative HbA1C predicts adverse outcomes following coronary artery bypass grafting surgery. Anesth Analg. 2014 Feb;118(2):277-287. doi: 10.1213/ANE.0000000000000100. |
| 23837943 | Background | Shinoda T, Murakami W, Takamichi Y, Iizuka H, Tanaka M, Kuwasako Y. Effect of remifentanil infusion rate on stress response in orthopedic surgery using a tourniquet application. BMC Anesthesiol. 2013 Jul 10;13:14. doi: 10.1186/1471-2253-13-14. eCollection 2013. |
| 21602751 | Background | Cok OY, Ozkose Z, Pasaoglu H, Yardim S. Glucose response during craniotomy: propofol-remifentanil versus isoflurane-remifentanil. Minerva Anestesiol. 2011 Dec;77(12):1141-8. Epub 2011 May 20. |
| 19161815 | Background | Lazar HL, McDonnell M, Chipkin SR, Furnary AP, Engelman RM, Sadhu AR, Bridges CR, Haan CK, Svedjeholm R, Taegtmeyer H, Shemin RJ; Society of Thoracic Surgeons Blood Glucose Guideline Task Force. The Society of Thoracic Surgeons practice guideline series: Blood glucose management during adult cardiac surgery. Ann Thorac Surg. 2009 Feb;87(2):663-9. doi: 10.1016/j.athoracsur.2008.11.011. No abstract available. |
| 32247539 | Derived | Subramaniam K, Sciortino C, Ruppert K, Monroe A, Esper S, Boisen M, Marquez J, Hayanga H, Badhwar V. Remifentanil and perioperative glycaemic response in cardiac surgery: an open-label randomised trial. Br J Anaesth. 2020 Jun;124(6):684-692. doi: 10.1016/j.bja.2020.01.028. Epub 2020 Apr 2. |
| BG001 | Fentanyl Group | Half of subjects enrolled will be randomized to the fentanyl group Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Fentanyl Group | Half of subjects enrolled will be randomized to the fentanyl group Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery. |
|
|
|
| Secondary | Insulin Requirement | Average dose of insulin (Units/ml) calculated for each group in the intraoperative period | Posted | Median | Full Range | Units/ml | Intraoperative period; Induction to end of surgery |
|
|
|
|
| Secondary | Number of Blood Glucose Values > 180 mg% | Blood glucose values that exceed 180 mg% will be counted | Posted | Median | Full Range | number of glucose values >180mg% | Intraoperative period, Induction to end of surgery |
|
|
|
|
| Secondary | Mean, Peak and Trough Intraoperative Blood Glucose (mg/dl) | Blood glucose measured every hour | Posted | Median | Full Range | Mg/dL | Intraoperative period; Induction to end of surgery |
|
|
|
|
| Secondary | Postoperative Blood Glucose | Mean and peak blood glucose levels postoperatively | Posted | Median | Full Range | mg/dl | From ICU Admission (After Surgery) Until 24 hours postoperatively |
|
|
|
|
| Secondary | Total Postoperative Regular Insulin | Total units of regular insulin required post-operatively | Posted | Median | Full Range | International Units | From ICU Admission (After Surgery) Until 24 hours postoperatively |
|
|
|
|
| Secondary | Intraoperative Pre-cardiopulmonary Bypass Hemodynamic Stability | Blood pressure (systolic, diastolic and mean), Heart rate every 5 minutes from induction of anesthesia till systemic heparinization before cardiopulmonary bypass | Resources not available to analyze | Posted | induction of anesthesia till systemic heparinization before cardiopulmonary bypass |
|
|
| Secondary | Stress Hormone Levels-Cortisol (µg/dl) | Serum cortisol levels (measured as µg/dl) taken at: Prebypass, cardiopulmonary bypass (2 samples: at start of bypass and end of bypass), postbypass, ICU 8 hours postoperative period | Posted | Median | Full Range | µg/dl | Perioperative period (Intraoperatively and 8 hours postoperatively) |
|
|
|
|
| Secondary | Inflammatory Mediator Levels, Interleukin-1b, Interleukin 6 and Tumor Necrosis Factor (TNF) (pg/ml) | Inflammatory mediator levels, Interleukin-1b (IL-1b), Interleukin 6 (IL-6) and Tumor Necrosis Factor Alpha (TNFa) (all measured in pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples:30 min start of bypass (CPB-30) and end of bypass (CPB-END), postbypass, ICU 8 hours postoperative period | Posted | Median | Full Range | pg/ml | Perioperative period (Intraoperatively and 8 hours postoperatively) |
|
|
|
|
| Secondary | Stress Hormone Levels-ACTH, GH, Glucagon (pg/ml) | Adreno-corticotrophic hormone (ACTH), Growth Hormone (GH) and Glucagon (measured as pg/ml) taken at: Prebypass, cardiopulmonary bypass (2 samples: 30 mins after start of bypass (CPB 30) and end of bypass (CPB END), post-bypass and ICU 8 hours postoperative period | Posted | Median | Full Range | pg/ml | Perioperative period (Intraoperatively and 8 hours postoperatively) |
|
|
|
|
| Secondary | Society of Thoracic Surgery Patient Outcomes | Postoperative outcomes collected from the Society of Thoracic Surgery (STS) database. 30 day Mortality (outcome 1) and 30 day Readmission (outcome 2) cerebral vascular accident(outcome 3), prolonged mechanical ventilation (outcome 4), renal failure (outcome 5), atrial fibrillation (outcome 6), cardiac arrest (outcome 7) | Posted | Number | participants | 30 day outcomes |
|
|
|
|
| Secondary | Postoperative Pain | Pain scores; Every day 6 hour for 48 hours postoperative period | This is a mixed model analysis to account for missing VAS values | Posted | Mean | Standard Deviation | score on a scale | Every day 6 hour for 48 hours postoperative period |
|
|
|
|
| Secondary | Emergence From Anesthesia | Time to extubation after completion of surgery in the operating room and intensive care unit | Posted | Median | Full Range | Hours | Immediate postoperative period until 30 days post-operatively |
|
|
|
| Secondary | Wound Hyperalgesia | Von frey hair objective testing | Posted | Mean | Standard Deviation | g/mm^2 | 96 hours postoperatively |
|
|
|
| Secondary | Development of Chronic Pain | Telephonic call Numeric pain scale; Scale is 0-10, with 10 being the highest pain. | Posted | Median | Inter-Quartile Range | score on a scale | 1, 3, 6 and 12 months after discharge from the hospital |
|
|
|
| Secondary | Glycemic Variability | Coefficient of variation in blood glucose levels. Denotes how large the fluctuations in blood glucose are. Higher numbers indicate increased variation. | Posted | Mean | Full Range | Percent of Mean Glucose Level | From the start of induction till 24 hours postoperatively |
|
|
|
|
| 3 |
| 54 |
| 1 |
| 54 |
| 28 |
| 54 |
| EG001 | Fentanyl Group | Half of subjects enrolled will be randomized to the fentanyl group Fentanyl: Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery. | 6 | 52 | 5 | 52 | 27 | 52 |
| Pericardial effusion/tamponade | Cardiac disorders |
|
| Stroke | Nervous system disorders |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
|
|
| Sepsis | Surgical and medical procedures | Systematic Assessment |
|
| Cerebrovascular Accident | Vascular disorders | Systematic Assessment |
|
| Transient Ischemic Attacks | Vascular disorders | Systematic Assessment |
|
| Prolonged Mechanical Ventilation (>72 hours) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Reintubation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pulmonary Thromboembolism | Vascular disorders | Systematic Assessment |
|
| Venous Thromboembolism | Vascular disorders | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Dialysis | Renal and urinary disorders | Systematic Assessment |
|
| Rhythm Requiring Permanent Pacemaker Insertion | Surgical and medical procedures | Systematic Assessment |
|
| Rhythm Requiring Permanent Pacemaker/ACID | Surgical and medical procedures | Systematic Assessment | An ACID is a Automated Implantable Cardioverter Defibrillator |
|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
|
| Multisystem Organ Failure | General disorders | Systematic Assessment |
|
| Readmission within 30 days | General disorders | Systematic Assessment |
|
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Not provided
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Lowest Intraoperative Blood Glucose |
|
| Peak Intraoperative Blood Glucose | t-test, 2 sided | 0.0003 | Superiority | Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Lowest Intraoperative Blood Glucose | t-test, 2 sided | 0.98 | Superiority | Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Peak Postoperative Blood Glucose | t-test, 2 sided | 0.25 | Superiority | Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Serum Cortisol End of CPB |
|
| Serum Cortisol End of Surgery |
|
| Serum Cortisol Postoperative (8 Hours) |
|
| 30 minutes after the start of CPB | t-test, 2 sided | <0.0001 | Non-Inferiority | Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| End of CPB | t-test, 2 sided | <0.0001 | Non-Inferiority | Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| End of Surgery | t-test, 2 sided | <0.0001 | Non-Inferiority | Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Postoperative (8 hours) | t-test, 2 sided | 0.021 | Non-Inferiority | Power calculation was performed based on the assumption that continuous remifentanil infusion would reduce the percentage of patients with unacceptable blood glucose values (more than one BG > 180 mg) to an absolute value of 20%. Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| IL-1b CPB-END |
|
| IL-1b post-bypass |
|
| IL-1b 8-HR |
|
| IL-6 Pre-bypass |
|
| IL-6 CPB-30 |
|
| IL-6 CPB-END |
|
| IL-6 post-bypass |
|
| IL-6 8HR |
|
| TNFa-Pre-bypass |
|
| TNFa CPB-30 |
|
| TNFa CPB-END |
|
| TNFa post-bypass |
|
| TNFa 8HR |
|
Analyzing the IL-1b CPB-30
| t-test, 2 sided |
| 0.815 |
| Superiority |
Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the CPB-END | t-test, 2 sided | 0.715 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the IL-1b post-bypass | t-test, 2 sided | 0.330 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the IL-1b 8 HR | t-test, 2 sided | 0.651 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the IL-6 Pre bypass | t-test, 2 sided | 0.439 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the IL-6 CPB-30 | t-test, 2 sided | 0.284 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the CPB-END | t-test, 2 sided | 0.779 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the IL-6 post-bypass | t-test, 2 sided | 0.274 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the IL-6 8HR | t-test, 2 sided | 0.601 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the TNFa Pre-bypass | t-test, 2 sided | 0.315 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the TNFa CPB-30 | t-test, 2 sided | 0.062 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the TNFa CPB-END | t-test, 2 sided | 0.090 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the TNFa- post-bypass | t-test, 2 sided | 0.004 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the TNFa-8HR | t-test, 2 sided | 0.074 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| ACTH CPB-END |
|
| ACTH post-bypass |
|
| ACTH 8-hr |
|
| GH-Pre-bypass |
|
| GH-CPB-30 |
|
| GH-CPB-END |
|
| GH-post-bypass |
|
| GH-8HR |
|
| Glucagon pre-bypass |
|
| Glucagon CPB-30 |
|
| Glucagon CPB-End |
|
| Glucagon post-bypass |
|
| Glucagon 8-HR |
|
Analyzing the ACTH CPB-30 group. |
| t-test, 2 sided |
| <0.0001 |
| Non-Inferiority |
Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the ACTH CPB-END | t-test, 2 sided | <0.0001 | Non-Inferiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the ACTH post-bypass | t-test, 2 sided | <0.0001 | Non-Inferiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the ACTH 8-hr | t-test, 2 sided | 0.014 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the GH- Pre-bypass | t-test, 2 sided | 0.100 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| GH-CPB-30 | t-test, 2 sided | <0.0001 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the GH-CPB-END | t-test, 2 sided | 0.009 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| GH-Post-bypass | t-test, 2 sided | 0.046 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the GH-8-hr | t-test, 2 sided | 0.695 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the Glucagon Pre Bypass | t-test, 2 sided | 0.455 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the Glucagon CPB-30 | t-test, 2 sided | 0.059 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the Glucagon CPB-END | t-test, 2 sided | 0.175 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the Glucagon Post-bypass | t-test, 2 sided | 0.062 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Analyzing the Glucagon 8-hr | t-test, 2 sided | 0.261 | Superiority | Under these conditions, 52 patients per group would have 90% power to detect a significant difference (alpha = .05) between the groups. A total of 116 patients were recruited to allow dropouts. |
| Cerebral Vascular Accident |
|
| Prolonged mechanical ventilation |
|
| renal failure |
|
| atrial fibrillation |
|
| cardiac arrest |
|
| 0.03 |
| Superiority |
| Cerebral Vascular Accident | Chi-squared | 0.24 | Superiority |
| Prolonged Mechanical Ventilation | Chi-squared | 0.93 | Superiority |
| Renal Failure | Chi-squared | 1 | Superiority |
| Atrial Fibrillation | Chi-squared | 0.10 | Superiority |
| cardiac arrest | Chi-squared | 1 | Superiority |
| Hrs 7-12 |
|
|
| Hrs 13-18 |
|
|
| Hrs 19-24 |
|
|
| Hrs 25-30 |
|
|
| Hrs 31-36 |
|
|
| Hrs 37-42 |
|
|
| Hrs 43-48 |
|
|
| 0.339 |
| Superiority |
| Hrs 13-18 | t-test, 2 sided | 0.006 | Superiority |
| Hrs 19-24 | t-test, 2 sided | 0.747 | Superiority |
| Hrs 25-30 | t-test, 2 sided | 0.568 | Superiority |
| Hrs 31-36 | t-test, 2 sided | 0.924 | Superiority |
| Hrs 37-42 | t-test, 2 sided | 0.501 | Superiority |
| Hrs 43-48 | t-test, 2 sided | 0.977 | Superiority |
| 96 hr pain threshold |
|
| S-LANSS 6 mo |
|
| S-LANSS 12 mo |
|