C.Surgical Procedure; Cardiac, Delirium, Postoperative Complications
Conditions
Keywords
Delirium, Cardiac Surgical Procedures, Postoperative Complications, Dexmedetomidine, Prevention
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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: 1. Refuse to participate; 2. Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia; 3. Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier; 4. History of brain injury or neurosurgery; 5. Preoperative sick sinus syndrome, severe bradycardia (HR \< 50 bpm), second-degree or above atrioventricular block without pacemaker; 6. Severe hepatic dysfunction (Child-Pugh class C); 7. Severe renal dysfunction (requirement of renal replacement therapy); 8. Other conditions that are considered unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Delirium | During the first five days after surgery | Delirium was assessed with the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) twice daily during the first five days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Function | on the sixth day after surgery, and on the 30th day after surgery | 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 |
| Incidence of Non-delirium Complications After Surgery | Occurrence of non-delirium complications will be monitored until 30 days 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | During the first five days after surgery | 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). |
| Length of Stay in Hospital After Surgery | From end of surgery until discharge from hospital or 30 days after surgery | Results was presented as median (95% confidence interval). |
| Subjective Sleep Quality | During the first five 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). |
| Length of Stay in the Intensive Care Unit | From end of surgery until discharge from Intensive Care Unit or 30 days after surgery | Results was presented as median (95% confidence interval). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DEX Group participant who received dexmedetomidine | 142 |
| CTRL Group participants who recieved normal saline | 143 |
| Total | 285 |
Baseline characteristics
| Characteristic | Total | DEX Group | CTRL Group |
|---|---|---|---|
| Acute myocardial infarction | 28 Participants | 17 Participants | 11 Participants |
| Age, Continuous | 66.9 years STANDARD_DEVIATION 5.4 | 66.4 years STANDARD_DEVIATION 5.4 | 67.5 years STANDARD_DEVIATION 5.3 |
| Angiotensin Converting Enzyme Inhibitors/Angiotensin Receptor Blockers | 96 Participants | 50 Participants | 46 Participants |
| Antiplatelet drugs | 167 Participants | 85 Participants | 82 Participants |
| Arrhythmia | 61 Participants | 32 Participants | 29 Participants |
| Barthe Index(BI)score | 100 units on a scale | 100 units on a scale | 100 units on a scale |
| Body Mass Index kg/m^2 | 25.1 kg/m^2 STANDARD_DEVIATION 3.1 | 25.3 kg/m^2 STANDARD_DEVIATION 3.4 | 24.9 kg/m^2 STANDARD_DEVIATION 2.8 |
| Calcium Channel Blocker | 78 Participants | 33 Participants | 45 Participants |
| Chronic kidney disease | 8 Participants | 1 Participants | 7 Participants |
| Chronic Obstructive Ppulmonary Disease | 11 Participants | 7 Participants | 4 Participants |
| Delirium | 0 Participants | 0 Participants | 0 Participants |
| Diabetes Mellitus | 92 Participants | 43 Participants | 49 Participants |
| Education (year) | 9 years | 9 years | 9 years |
| European System for Cardiac Operative Risk Evaluation | 3 units on a scale | 3 units on a scale | 3 units on a scale |
| History of general anesthesia | 48 Participants | 24 Participants | 24 Participants |
| History of surgery | 107 Participants | 55 Participants | 52 Participants |
| Hospital Anxiety and Depression Scale score | 8 units on a scale | 8 units on a scale | 8 units on a scale |
| Hyperlipidemia | 99 Participants | 38 Participants | 61 Participants |
| Hypertension | 180 Participants | 89 Participants | 91 Participants |
| left ventricular ejection fraction (LVEF)% | 64.7 percentage | 64.4 percentage | 64.8 percentage |
| Mini-Mental State Examination（MMSE）score | 29 units on a scale | 29 units on a scale | 29 units on a scale |
| New York Heart Association (NYHA) Functional Classification I | 4 Participants | 2 Participants | 2 Participants |
| New York Heart Association (NYHA) Functional Classification II | 179 Participants | 87 Participants | 92 Participants |
| New York Heart Association (NYHA) Functional Classification III | 69 Participants | 33 Participants | 36 Participants |
| New York Heart Association (NYHA) Functional Classification IV | 5 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Female | 88 Participants | 47 Participants | 41 Participants |
| Sex: Female, Male Male | 197 Participants | 95 Participants | 102 Participants |
| Smoking | 117 Participants | 51 Participants | 66 Participants |
| Statins | 138 Participants | 63 Participants | 75 Participants |
| Stroke | 59 Participants | 26 Participants | 33 Participants |
| the American Society of Anesthesiologists (ASA) Classification II | 3 Participants | 1 Participants | 2 Participants |
| the American Society of Anesthesiologists (ASA) Classification III | 257 Participants | 128 Participants | 129 Participants |
| the American Society of Anesthesiologists (ASA) Classification IV | 25 Participants | 13 Participants | 12 Participants |
| Thyroid disease | 7 Participants | 4 Participants | 3 Participants |
| Tumor | 10 Participants | 7 Participants | 3 Participants |
| β-blocker | 129 Participants | 63 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 142 | 4 / 143 |
| other Total, other adverse events | 38 / 142 | 40 / 143 |
| serious Total, serious adverse events | 0 / 142 | 0 / 143 |
Outcome results
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.
Time frame: During the first five days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DEX Group | Incidence of Postoperative Delirium | 7 Participants |
| CTRL Group | Incidence of Postoperative Delirium | 11 Participants |
p-value: 0.34195% CI: [0.23, 1.65]Regression, Logistic
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
Time frame: on the sixth day after surgery, and on the 30th day after surgery
Population: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DEX Group | Cognitive Function | MMSE score on postoperative day 6 | 29 units on a scale |
| DEX Group | Cognitive Function | m-TICS score on postoperative day 30 | 34 units on a scale |
| CTRL Group | Cognitive Function | MMSE score on postoperative day 6 | 29 units on a scale |
| CTRL Group | Cognitive Function | m-TICS score on postoperative day 30 | 34 units on a scale |
p-value: 0.83Wilcoxon (Mann-Whitney)
p-value: 0.405Wilcoxon (Mann-Whitney)
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.
Time frame: Occurrence of non-delirium complications will be monitored until 30 days after surgery.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DEX Group | Incidence of Non-delirium Complications After Surgery | Stroke | 3 Participants |
| DEX Group | Incidence of Non-delirium Complications After Surgery | New onset arrythmia | 42 Participants |
| DEX Group | Incidence of Non-delirium Complications After Surgery | Pulmonary complications | 15 Participants |
| DEX Group | Incidence of Non-delirium Complications After Surgery | Upper gastrointestinal bleeding | 2 Participants |
| DEX Group | Incidence of Non-delirium Complications After Surgery | Surgical bleeding | 3 Participants |
| DEX Group | Incidence of Non-delirium Complications After Surgery | Wound dehiscence or infection | 11 Participants |
| DEX Group | Incidence of Non-delirium Complications After Surgery | Acute kidney injury | 37 Participants |
| DEX Group | Incidence of Non-delirium Complications After Surgery | IABP assistance | 6 Participants |
| CTRL Group | Incidence of Non-delirium Complications After Surgery | IABP assistance | 12 Participants |
| CTRL Group | Incidence of Non-delirium Complications After Surgery | Stroke | 3 Participants |
| CTRL Group | Incidence of Non-delirium Complications After Surgery | Wound dehiscence or infection | 7 Participants |
| CTRL Group | Incidence of Non-delirium Complications After Surgery | New onset arrythmia | 51 Participants |
| CTRL Group | Incidence of Non-delirium Complications After Surgery | Surgical bleeding | 3 Participants |
| CTRL Group | Incidence of Non-delirium Complications After Surgery | Pulmonary complications | 27 Participants |
| CTRL Group | Incidence of Non-delirium Complications After Surgery | Acute kidney injury | 44 Participants |
| CTRL Group | Incidence of Non-delirium Complications After Surgery | Upper gastrointestinal bleeding | 4 Participants |
Comparison: Incidence of total non-delirium complications within 30 days after surgeryp-value: 0.21495% CI: [0.47, 1.19]Regression, Logistic
Comparison: Incidence of stroke within 30 days after surgeryp-value: 0.99395% CI: [0.2, 5.08]Regression, Logistic
p-value: 0.27495% CI: [0.46, 1.25]Regression, Logistic
p-value: 0.0595% CI: [0.26, 1]Regression, Logistic
p-value: 0.42395% CI: [0.09, 2.75]Regression, Logistic
p-value: 0.99395% CI: [0.2, 5.08]Regression, Logistic
p-value: 0.32695% CI: [0.61, 4.34]Regression, Logistic
p-value: 0.37895% CI: [0.47, 1.33]Regression, Logistic
p-value: 0.15695% CI: [0.18, 1.32]Regression, Logistic
Other Pre-specified
Length of Stay in Hospital After Surgery
Results was presented as median (95% confidence interval).
Time frame: From end of surgery until discharge from hospital or 30 days after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DEX Group | Length of Stay in Hospital After Surgery | 9 days |
| CTRL Group | Length of Stay in Hospital After Surgery | 9 days |
p-value: 0.82695% CI: [0.77, 1.23]Log Rank
Other Pre-specified
Length of Stay in the Intensive Care Unit
Results was presented as median (95% confidence interval).
Time frame: From end of surgery until discharge from Intensive Care Unit or 30 days after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DEX Group | Length of Stay in the Intensive Care Unit | 45.0 hours |
| CTRL Group | Length of Stay in the Intensive Care Unit | 46.0 hours |
p-value: 0.78895% CI: [0.82, 1.31]Log Rank
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).
Time frame: During the first five days after surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DEX Group | Pain Intensity | Pain score after surgery(d1), at rest | 3 units on a scale |
| DEX Group | Pain Intensity | Pain score after surgery(d2), at rest | 4 units on a scale |
| DEX Group | Pain Intensity | Pain score after surgery(d3), at rest | 3 units on a scale |
| DEX Group | Pain Intensity | Pain score after surgery(d4), at rest | 2 units on a scale |
| DEX Group | Pain Intensity | Pain score after surgery(d5), at rest | 2 units on a scale |
| DEX Group | Pain Intensity | Pain score after surgery(d1), with coughing | 4 units on a scale |
| DEX Group | Pain Intensity | Pain score after surgery(d2), with coughing | 5 units on a scale |
| DEX Group | Pain Intensity | Pain score after surgery(d3), with coughing | 4 units on a scale |
| DEX Group | Pain Intensity | Pain score after surgery(d4), with coughing | 3 units on a scale |
| DEX Group | Pain Intensity | Pain score after surgery(d5), with coughing | 2 units on a scale |
| CTRL Group | Pain Intensity | Pain score after surgery(d3), with coughing | 4 units on a scale |
| CTRL Group | Pain Intensity | Pain score after surgery(d1), at rest | 3 units on a scale |
| CTRL Group | Pain Intensity | Pain score after surgery(d1), with coughing | 4 units on a scale |
| CTRL Group | Pain Intensity | Pain score after surgery(d2), at rest | 3 units on a scale |
| CTRL Group | Pain Intensity | Pain score after surgery(d5), with coughing | 2 units on a scale |
| CTRL Group | Pain Intensity | Pain score after surgery(d3), at rest | 2 units on a scale |
| CTRL Group | Pain Intensity | Pain score after surgery(d2), with coughing | 4 units on a scale |
| CTRL Group | Pain Intensity | Pain score after surgery(d4), at rest | 2 units on a scale |
| CTRL Group | Pain Intensity | Pain score after surgery(d4), with coughing | 3 units on a scale |
| CTRL Group | Pain Intensity | Pain score after surgery(d5), at rest | 1 units on a scale |
Comparison: this statistical analysis applies to the first row in Outcome 4, i.e., Pain score in Day 1 after surgery, at rest between DEX Group and CTRL groupp-value: 0.59695% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: this statistical analysis applies to the second row in Outcome 4, i.e., Pain score in Day 2 after surgery, at rest between DEX Group and CTRL groupp-value: 0.74395% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: 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 groupp-value: 0.28295% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: 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 groupp-value: 0.36895% CI: [0, 0]Wilcoxon (Mann-Whitney)
Comparison: 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 groupp-value: 0.39795% CI: [0, 0]Wilcoxon (Mann-Whitney)
Comparison: 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 groupp-value: 0.48695% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: 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 groupp-value: 0.41495% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: 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 groupp-value: 0.18795% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: 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 groupp-value: 0.12795% CI: [-1, 0]Wilcoxon (Mann-Whitney)
Comparison: 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 groupp-value: 0.37895% CI: [0, 0]Wilcoxon (Mann-Whitney)
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).
Time frame: During the first five days after surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| DEX Group | Subjective Sleep Quality | Subjective sleep quality after surgery(d2), score | 3 units on a scale |
| DEX Group | Subjective Sleep Quality | Subjective sleep quality after surgery(d4), score | 2 units on a scale |
| DEX Group | Subjective Sleep Quality | Subjective sleep quality after surgery(d3), score | 2 units on a scale |
| DEX Group | Subjective Sleep Quality | Subjective sleep quality after surgery(d5), score | 2 units on a scale |
| DEX Group | Subjective Sleep Quality | Subjective sleep quality after surgery(d1), score | 2 units on a scale |
| CTRL Group | Subjective Sleep Quality | Subjective sleep quality after surgery(d5), score | 2 units on a scale |
| CTRL Group | Subjective Sleep Quality | Subjective sleep quality after surgery(d1), score | 2 units on a scale |
| CTRL Group | Subjective Sleep Quality | Subjective sleep quality after surgery(d2), score | 3 units on a scale |
| CTRL Group | Subjective Sleep Quality | Subjective sleep quality after surgery(d3), score | 2 units on a scale |
| CTRL Group | Subjective Sleep Quality | Subjective sleep quality after surgery(d4), score | 2 units on a scale |
Comparison: 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 groupp-value: 0.83595% CI: [0, 0]Wilcoxon (Mann-Whitney)
Comparison: this statistical analysis applies to the first row in Outcome 5, i.e., subjective sleep quality in Day 1 after surgery, between DEX Group and CTRL groupp-value: 0.77795% CI: [0, 0]Wilcoxon (Mann-Whitney)
Comparison: this statistical analysis applies to the second row in Outcome 5, i.e., subjective sleep quality in Day 2 after surgery, between DEX Group and CTRL groupp-value: 0.91995% CI: [-1, 1]Wilcoxon (Mann-Whitney)
Comparison: 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 groupp-value: 0.32195% CI: [0, 0]Wilcoxon (Mann-Whitney)
Comparison: 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 groupp-value: 0.17495% CI: [0, 0]Wilcoxon (Mann-Whitney)