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| Name | Class |
|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
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Postoperative delirium (POD) is a frequently occurring complication after cardiac surgery. Its occurrence is associated with worse outcomes of patients, including increased morbidity, prolonged hospital stay, increased medical cost, and higher mortality. It is also associated with long-term cognitive decline and decreased quality of life. However, until recently, pharmacological interventions that can effectively prevent its occurrence are still limited. The purpose of this study is to investigate whether perioperative dexmedetomidine use can decrease the incidence of postoperative delirium in patients undergoing cardiac surgery.
Delirium is a state of global cerebral dysfunction manifested by acute disturbance of consciousness, attention, cognition and perception. It develops over a short period of time (usually hours to days) and tends to fluctuate during the course of the day. The reported incidences of delirium after cardiac surgery varied from 21% to 47%. The occurrence of postoperative delirium has significant harmful effects on patients' outcomes, including increased morbidity, prolonged hospital stay, increased medical cost, and higher mortality. Its occurrence is also associated with long-term cognitive decline and decreased quality of life.
The exact pathogenesis that lead to the occurrence of POD are still unclear, and possibly involves mechanisms such as inflammation, pain and sleep deprivation after surgery. Furthermore, it has been shown that anesthesia management might also have exerted some effects. Studies found that avoidance of unnecessary deep anesthesia (under the guidance of Bispectral Index monitoring) decreases the incidence of POD. Theoretically, measures that decreases the requirement of anesthetics while maintaining adequate depth of anesthesia and those that alleviates inflammation and improves postoperative analgesia as well as sleep quality will decrease the incidence of POD.
Dexmedetomidine is a highly selective alpha-2 adrenoreceptor agonists that provides anxiolysis, sedation and modest analgesia with minimal respiratory depression. Studies showed that, when used as an adjunctive anesthetics, dexmedetomidine significantly decreases the requirement of opioid analgesics and other sedatives during anesthesia. A recent study of our group found that continuous infusion of low-dose dexmedetomidine (0.2 ug/kg/h) during the first night after surgery significantly improved subjective sleep quality. Two randomized controlled trials found that, when compared with traditional sedatives (midazolam and propofol) and analgesics (such as morphine), use of dexmedetomidine in patients after cardiac surgery is associated with decreased risk of delirium. However, questions still exist as to whether dexmedetomidine prevent delirium or just does not increase its occurrence since traditional sedatives/analgesics themselves increases the risk of delirium. Furthermore, animal experiments showed that dexmedetomidine inhibits the degree of inflammation induced by endotoxins.
The investigators hypothesize that use of dexmedetomidine as an adjunctive agent during the perioperative period can decrease the incidence of postoperative delirium in patients undergoing cardiac surgery, possibly by decreasing the requirement of anesthetics during surgery, by ameliorating analgesia as well as sleep quality after surgery, and by alleviating the degree of perioperative inflammatory response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dex group | Experimental | The intervention drug (dexmedetomidine hydrochloride for injection) will be administered during a period from before anesthesia induction until the end of mechanical ventilation after surgery. |
|
| Placebo group | Placebo Comparator | The placebo drug (normal saline, i.e., 0.9% sodium chloride for injection) will be administered in the same way and rate for a same duration as that in the Dex group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexmedetomidine hydrochloride for injection | Drug | Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml). Before the induction of anesthesia, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 μg/kg in 10 minutes), followed by continuous infusion at a rate of [0.1*kg] ml/h (i.e., dexmedetomidine at a rate of 0.4 μg /kg/h) until the end of surgery. At the end of surgery, the infusion rate will be decreased to [0.025*kg] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Postoperative Delirium | Delirium was assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first five days after surgery. | During the first five days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Function | Cognitive function was assessed with the Mini Mental State Examination (MMSE) at baseline (the day before surgery) and on the sixth day after surgery, and with modified telephone interview for cognitive status (m-TICS) on the 30th day after surgery. The introduction of MMSE scale has been explained in the baseline part in the result section. The Telephone Interview for Cognitive Status-modified scale(m-TICS) is one of the most popular telephone interview-based screening instruments for mild cognitive impairment and dementia. It consists 11 items including wordlist memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis, which score ranges from 0 to 48, with higher scores indicating better cognitive function |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Pain intensity was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = no pain, 10 = the worst possible pain). | During the first five days after surgery |
| Subjective Sleep Quality |
Inclusion Criteria:
Patients of 60 years or older who are planning to receive cardiac surgery (CABG and/or valve replacement surgery)
Exclusion Criteria:
Patients will be excluded if they meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21971396 | Background | Guenther U, Radtke FM. Delirium in the postanaesthesia period. Curr Opin Anaesthesiol. 2011 Dec;24(6):670-5. doi: 10.1097/ACO.0b013e32834c7b44. | |
| 23040280 | Background | Morandi A, Pandharipande PP, Jackson JC, Bellelli G, Trabucchi M, Ely EW. Understanding terminology of delirium and long-term cognitive impairment in critically ill patients. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):267-76. doi: 10.1016/j.bpa.2012.08.001. |
| Label | URL |
|---|---|
| Different versions of Confusion Assessemnt Method for the Intensive Care Unit (CAM-ICU) and their validation papers were found in this web. | View source |
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Data will be available on request.
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| ID | Title | Description |
|---|---|---|
| FG000 | DEX Group | participant who received dexmedetomidine |
| FG001 | CTRL Group | participants who recieved normal saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DEX Group | participant who received dexmedetomidine |
| BG001 | CTRL Group | participants who recieved normal saline |
| 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 | Incidence of Postoperative Delirium | Delirium was assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first five days after surgery. | Posted | Count of Participants | Participants | During the first five days after surgery |
|
|
From the start of study drug infusion until 24 hours after the end of study drug infusion.
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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 | DEX Group | participant who received dexmedetomidine | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraoperative Bradycardia | Cardiac disorders | Systematic Assessment | Heart rate < 45 beat per minute or a decrease of more than 30% from baseline (average value in the ward), and lasting for at least 5 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dong-Xin Wang,PHD,the director of department of Anesthesiology and Critical Care Medicine | Peking University First Hospital | +8613910731903 | wangdongxin@hotmail.com |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D007267 | Injections |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| 0.9% sodium chloride for injection | Drug | Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared. Before the induction of anesthesia, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes, followed by continuous infusion at a rate of [0.1*kg] ml/h until the end of surgery. At the end of surgery, the infusion rate will be decreased to [0.025*kg] ml/h and continued until the end of mechanical ventilation after surgery. |
|
|
| on the sixth day after surgery, and on the 30th day after surgery |
| Incidence of Non-delirium Complications After Surgery | Non-delirium complications was defined as any conditions other than delirium that occurred during the first 30 days after surgery and required therapeutic intervention.Complications listed here were not considered adverse events in this study. | Occurrence of non-delirium complications will be monitored until 30 days after surgery. |
Subjective sleep quality was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = best sleep, 10 = the worst possible sleep).
| During the first five days after surgery |
| Length of Stay in the Intensive Care Unit | Results was presented as median (95% confidence interval). | From end of surgery until discharge from Intensive Care Unit or 30 days after surgery |
| Length of Stay in Hospital After Surgery | Results was presented as median (95% confidence interval). | From end of surgery until discharge from hospital or 30 days after surgery |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index "kg/m^2" | Mean | Standard Deviation | kg/m^2 |
|
| Education (year) | Median | Inter-Quartile Range | years |
|
| Hypertension | Count of Participants | Participants |
|
| Arrhythmia | Count of Participants | Participants |
|
| Stroke | Count of Participants | Participants |
|
| Chronic Obstructive Ppulmonary Disease | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Chronic kidney disease | Count of Participants | Participants |
|
| Tumor | Count of Participants | Participants |
|
| Thyroid disease | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
|
| Acute myocardial infarction | Count of Participants | Participants |
|
| Calcium Channel Blocker | Count of Participants | Participants |
|
| Angiotensin Converting Enzyme Inhibitors/Angiotensin Receptor Blockers | Count of Participants | Participants |
|
| β-blocker | Count of Participants | Participants |
|
| Statins | Count of Participants | Participants |
|
| Antiplatelet drugs | Count of Participants | Participants |
|
| European System for Cardiac Operative Risk Evaluation | European System for Cardiac Operative Risk Evaluation is a risk model which allows the calculation of the risk of death after a heart operation. The model asks for 17 items of information about the patient, the state of the heart and the proposed operation,and uses logistic regression to calculate the risk of death. The minimum score is 0 indicating the lowest risk of death after sugery while the maximum score is 35 indicating the highest risk of death after the heart operation | Median | Inter-Quartile Range | units on a scale |
|
| History of surgery | Count of Participants | Participants |
|
| History of general anesthesia | Count of Participants | Participants |
|
| New York Heart Association (NYHA) Functional Classification | New York Heart Association (NYHA) Functional Classification provides a simple way of classifying the extent of heart failure. It has four categories based on the degree of limitation during physical activity,the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina. From Class I to Class IV, the degree of heart failure is increased with more severe symptoms, for example, no shortness of breath when walking, climbing stairs occurs in patient of Class I while symptoms even exist while at rest in patient of Class IV. | 28 participants (17 in the DEX group and 11 in the CTRL group) are acute myocardial infarction ,so their cardiac funcion can not be judged by the NYHA function class | Count of Participants | Participants |
|
| left ventricular ejection fraction (LVEF)% | Left ventricular ejection fraction (LVEF) is the fraction of blood ejected from Left ventricle with each heart beat,which is calculated by dividing the stroke volume by the end-diastolic volume. In clinical practice, LVEF is most commonly measured by an echocardiogram and serves as a general measure of a person's cardiac function. | Median | Inter-Quartile Range | percentage |
|
| the American Society of Anesthesiologists (ASA) Classification | The ASA physical status classification system is a system for assessing the fitness of patients before surgery raised by the American Society of Anesthesiologists (ASA). The ASA class has 6 levels. From Class 1 to Class 5, the comorbidity of the patient and the risk to surgery operation are both increased. Class 6 is specially scene indicating a brain-dead patient whose organs are being removed for donor purposes. | Count of Participants | Participants |
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| Mini-Mental State Examination（MMSE）score | The Mini-Mental State Examination (MMSE) is a questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It is used to estimate the severity and progression of cognitive impairment and to follow the course of cognitive changes in an individual over time. Administration of the test takes between 5 and 10 minutes and examines functions including registration, attention and calculation, recall, language, ability to follow simple commands and orientation. The MMSE scores range from 0 to 30, with higher scores indicating better cognitive function | Median | Inter-Quartile Range | units on a scale |
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| Hospital Anxiety and Depression Scale score | Hospital Anxiety and Depression Scale (HADS) is commonly used to determine the levels of anxiety and depression of the patient. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS scores range from 0 to 42, with higher scores indicating more severe anxiety anddepression. | Median | Inter-Quartile Range | units on a scale |
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| Barthe Index(BI)score | The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). It uses ten variables describing ADL and mobility, which index range from 0 to 100, with higher score indicating better daily life activity and a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. | Median | Inter-Quartile Range | units on a scale |
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| Delirium | Count of Participants | Participants |
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| Participants |
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| Secondary | Cognitive Function | Cognitive function was assessed with the Mini Mental State Examination (MMSE) at baseline (the day before surgery) and on the sixth day after surgery, and with modified telephone interview for cognitive status (m-TICS) on the 30th day after surgery. The introduction of MMSE scale has been explained in the baseline part in the result section. The Telephone Interview for Cognitive Status-modified scale(m-TICS) is one of the most popular telephone interview-based screening instruments for mild cognitive impairment and dementia. It consists 11 items including wordlist memory, orientation, attention, repetition, conceptual knowledge and nonverbal praxis, which score ranges from 0 to 48, with higher scores indicating better cognitive function | 5 patients (3 in CTRL group and 2 in DEX group) did not complete the MMSE test on postoperative day 6;17 patients (12 in CTRL group and 5 in DEX group) did not complete the m-TICS test on postoperative day 30 | Posted | Median | Inter-Quartile Range | units on a scale | on the sixth day after surgery, and on the 30th day after surgery |
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| Secondary | Incidence of Non-delirium Complications After Surgery | Non-delirium complications was defined as any conditions other than delirium that occurred during the first 30 days after surgery and required therapeutic intervention.Complications listed here were not considered adverse events in this study. | Posted | Count of Participants | Participants | Occurrence of non-delirium complications will be monitored until 30 days after surgery. |
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| Other Pre-specified | Pain Intensity | Pain intensity was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = no pain, 10 = the worst possible pain). | Posted | Median | Inter-Quartile Range | units on a scale | During the first five days after surgery |
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| Other Pre-specified | Subjective Sleep Quality | Subjective sleep quality was assessed daily at 8 am during the first five days after surgery with the Numeric Rating Scale (NRS, 0 = best sleep, 10 = the worst possible sleep). | Posted | Median | Inter-Quartile Range | units on a scale | During the first five days after surgery |
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| Other Pre-specified | Length of Stay in the Intensive Care Unit | Results was presented as median (95% confidence interval). | Posted | Median | 95% Confidence Interval | hours | From end of surgery until discharge from Intensive Care Unit or 30 days after surgery |
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| Other Pre-specified | Length of Stay in Hospital After Surgery | Results was presented as median (95% confidence interval). | Posted | Median | 95% Confidence Interval | days | From end of surgery until discharge from hospital or 30 days after surgery |
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| 142 |
| 0 |
| 142 |
| 38 |
| 142 |
| EG001 | CTRL Group | participants who recieved normal saline | 4 | 143 | 0 | 143 | 40 | 143 |
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| Intraoperative Hypotension | Vascular disorders | Systematic Assessment | a decrease of systolic blood pressure of more than 30% from baseline (average value in the ward) and lasting for at least 15 minutes |
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| Postoperative Bradycardia | Cardiac disorders | Systematic Assessment | Heart rate < 45 beat per minute or a decrease of more than 30% from baseline (average value in the ward), and lasting for at least 5 minutes |
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| Postoperative Hypotension | Vascular disorders | Systematic Assessment | a decrease of systolic blood pressure of more than 30% from baseline (average value in the ward) and lasting for at least 15 minutes |
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Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D004333 |
| Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| III |
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| IV |
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| IV |
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| m-TICS score on postoperative day 30 |
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| 0.405 |
m-TICS |
| Median Difference (Final Values) |
| 0 |
| 2-Sided |
| Other |
| Pulmonary complications |
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| Upper gastrointestinal bleeding |
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| Surgical bleeding |
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| Wound dehiscence or infection |
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| Acute kidney injury |
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| IABP assistance |
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| Regression, Logistic |
| 0.993 |
| Odds Ratio (OR) |
| 1.01 |
| 2-Sided |
| 95 |
| 0.20 |
| 5.08 |
| Other |
stroke |
| Regression, Logistic | 0.274 | Odds Ratio (OR) | 0.76 | 2-Sided | 95 | 0.46 | 1.25 | Other | New onset arrythmia |
| Regression, Logistic | 0.050 | Odds Ratio (OR) | 0.51 | 2-Sided | 95 | 0.26 | 1.00 | Other | Pulmonary complications |
| Regression, Logistic | 0.423 | Upper gastrointestinal bleeding | Odds Ratio (OR) | 0.50 | 2-Sided | 95 | 0.09 | 2.75 | Other |
| Regression, Logistic | 0.993 | Surgical bleeding | Odds Ratio (OR) | 1.01 | 2-Sided | 95 | 0.20 | 5.08 | Other |
| Regression, Logistic | 0.326 | Wound dehiscence or infection | Odds Ratio (OR) | 1.63 | 2-Sided | 95 | 0.61 | 4.34 | Other |
| Regression, Logistic | 0.378 | Acute kidney injur | Odds Ratio (OR) | 0.79 | 2-Sided | 95 | 0.47 | 1.33 | Other |
| Regression, Logistic | 0.156 | IABP assistance | Odds Ratio (OR) | 0.48 | 2-Sided | 95 | 0.18 | 1.32 | Other |
| Pain score after surgery(d3), at rest |
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| Pain score after surgery(d4), at rest |
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| Pain score after surgery(d5), at rest |
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| Pain score after surgery(d1), with coughing |
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| Pain score after surgery(d2), with coughing |
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| Pain score after surgery(d3), with coughing |
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| Pain score after surgery(d4), with coughing |
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| Pain score after surgery(d5), with coughing |
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| Wilcoxon (Mann-Whitney) |
| 0.743 |
| Median Difference (Final Values) |
| 0 |
| 2-Sided |
| 95 |
| -1 |
| 0 |
| Other |
| this statistical analysis applies to the third row in Outcome 4, i.e., Pain score in Day 3 after surgery, at rest between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.282 | Median Difference (Final Values) | 0 | 2-Sided | 95 | -1 | 0 | Other |
| this statistical analysis applies to the fourth row in Outcome 4, i.e., Pain score in Day 4 after surgery, at rest between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.368 | Median Difference (Final Values) | 0 | 2-Sided | 95 | 0 | 0 | Other |
| this statistical analysis applies to the fifth row in Outcome 4, i.e., Pain score in Day 5 after surgery, at rest between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.397 | Median Difference (Final Values) | 0 | 2-Sided | 95 | 0 | 0 | Other |
| this statistical analysis applies to the sixth row in Outcome 4, i.e., Pain score in Day 1 after surgery, with coughing between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.486 | Median Difference (Final Values) | 0 | 2-Sided | 95 | -1 | 0 | Other |
| this statistical analysis applies to the seventh row in Outcome 4, i.e., Pain score in Day 2 after surgery, with coughing between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.414 | Median Difference (Final Values) | 0 | 2-Sided | 95 | -1 | 0 | Other |
| this statistical analysis applies to the eighth row in Outcome 4, i.e., Pain score in Day 3 after surgery, with coughing between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.187 | Median Difference (Final Values) | 0 | 2-Sided | 95 | -1 | 0 | Other |
| this statistical analysis applies to the ninth row in Outcome 4, i.e., Pain score in Day 4 after surgery, with coughing between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.127 | Median Difference (Final Values) | 0 | 2-Sided | 95 | -1 | 0 | Other |
| this statistical analysis applies to the tenth row in Outcome 4, i.e., Pain score in Day 5 after surgery, with coughing between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.378 | Median Difference (Final Values) | 0 | 2-Sided | 95 | 0 | 0 | Other |
| Subjective sleep quality after surgery(d3), score |
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| Subjective sleep quality after surgery(d4), score |
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| Subjective sleep quality after surgery(d5), score |
|
| Wilcoxon (Mann-Whitney) |
| 0.919 |
| Median Difference (Final Values) |
| 0 |
| 2-Sided |
| 95 |
| -1 |
| 1 |
| Other |
| this statistical analysis applies to the third row in Outcome 5, i.e., subjective sleep quality in Day 3 after surgery, between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.835 | Median Difference (Final Values) | 0 | 2-Sided | 95 | 0 | 0 | Other |
| this statistical analysis applies to the fourth row in Outcome 5, i.e., subjective sleep quality in Day 4 after surgery, between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.321 | Median Difference (Final Values) | 0 | 2-Sided | 95 | 0 | 0 | Other |
| this statistical analysis applies to the fifth row in Outcome 5, i.e., subjective sleep quality in Day 5 after surgery, between DEX Group and CTRL group | Wilcoxon (Mann-Whitney) | 0.174 | Median Difference (Final Values) | 0 | 2-Sided | 95 | 0 | 0 | Other |