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Postoperative delirium after total knee replacement surgery has been related to significant morbidity and mortality among high risk patients. Anesthetic care might play a role in the development of postoperative delirium.
The purpose of this study is to compare the incidence of postoperative delirium between different intraoperative sedation regimen. Delirium assessment using standardized screening tools will be done every 8 hours after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propofol-fentanyl | Experimental | Fentanyl 0.5 mcg/kg Propofol Target-controlled infusion to achieve MOAA/S 3-4 as end point of sedation Bispectral index (BIS) monitoring |
|
| Dexmedetomidine | Experimental | Fentanyl 0.5 mcg/kg Dexmedetomidine in incremental titrated dose for moderate sedation to achieve MOAA/S 3-4 as end-point of titration Bispectral index (BIS) monitoring |
|
| Fentanyl | Experimental | Fentanyl 0.5 mcg/kg Supplemental dosage of fentanyl for intraoperative anxiolysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | target-controlled infusion starting for Cet 0.1 mcg/ml to achieve MOAA/S 3-4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of age on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between age 65-75, 75-85, and >85 years of age | Up to 7 days |
| Apolipoprotein genotype |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siriraj Hospital | Bangkok Noi | Bangkok | 10700 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26352694 | Background | Gleason LJ, Schmitt EM, Kosar CM, Tabloski P, Saczynski JS, Robinson T, Cooper Z, Rogers SO Jr, Jones RN, Marcantonio ER, Inouye SK. Effect of Delirium and Other Major Complications on Outcomes After Elective Surgery in Older Adults. JAMA Surg. 2015 Dec;150(12):1134-40. doi: 10.1001/jamasurg.2015.2606. | |
| 26229855 | Background |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D020927 | Dexmedetomidine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Dexmedetomidine | Drug | Incremental titration of dexmedetomidine starting from 0.1 mcg/kg/hr to achieve MOAA/S 3-4 |
|
| Fentanyl | Drug | 0.25 mcg fo Fentanyl for anxiolysis |
|
ApoE epsilon subtype analysis
| 1 days |
| The effect of Apolipoprotein genotype on the incidence of postoperative delirium | ApoE epsilon subtype analysis | Up to 7 days |
| Inflammatory biomarker | Preoperative and postoperative comparison of inflammatory biomarker (IL-1, IL-6 TNF, S100b protein) | 2 days |
| The effect of delirium on inflammatory biomarker levels | Preoperative and postoperative comparison of inflammatory biomarker (IL-1, IL-6 TNF, S100b protein) comparison between delirium and non-delirium group | Up to 7 days |
| The effect of gender on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between male and female | Up to 7 days |
| The effect of ASA-physical status on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between ASA-PS I-II and III-IV | Up to 7 days |
| The effect of alcohol consumption on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between amount of alcohol consumption (standard drink/day) | Up to 7 days |
| The effect of cognitive inpairment on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without cognitive impairment. TMSE score will be use to determine cognitive status | Up to 7 days |
| The effect of coronary artery disease on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without coronary artery disease. Preoperative diagnosis of coronary artery disease will be used. | Up to 7 days |
| The effect of cerebrovascular disease on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without cerebrovascular disease. Preoperative diagnosis of cerebrovascular disease will be used. | Up to 7 days |
| The effect of chronic kidney disease on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without chronic kidney disease. Preoperative diagnosis of cerebrovascular disease will be used. | Up to 7 days |
| The effect of liver disease on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without liver disease. Preoperative diagnosis of liver disease will be used. | Up to 7 days |
| The effect of hypertension on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without hypertension. Preoperative diagnosis of hypertension will be used. | Up to 7 days |
| The effect of diabetes mellitus on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without diabetes mellitus. Preoperative diagnosis of diabetes will be used. | Up to 7 days |
| The effect of postoperative pain on the incidence of postoperative delirium | Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with mild (pain score 0-3), moderate (4-7) and severe (7-10). Numeric rating scale will be used. | Up to 7 days |
| The effect of intraoperative BIS value on the incidence of postoperative delirium | Intraoperative BIS value comparison between delirium and non-delirium group. Positive CAM-ICU result and confirmed DSM-V criteria will be used to diagnose delirium | 7 days |
| The effect of intraoperative blood transfusion and blood loss on the incidence of postoperative delirium | Intraoperative blood transfusion and blood loss will be compared between delirium and non-delirium group. Positive CAM-ICU result and confirmed DSM-V criteria will be used to diagnose delirium | 7 days |
| The effect of delirium on hospital length of stay | The hospital length of stay will be compared between delirium and non-delirium group. Positive CAM-ICU result and confirmed DSM-V criteria will be used to diagnose delirium | 7 days |
| The effect of delirium on postoperative rehabilitation | The time to assisted walking in the postoperative period will be compared between delirium and non-delirium group. Positive CAM-ICU result and confirmed DSM-V criteria will be used to diagnose delirium | 7 days |
| The effect of delirium on postoperative complications. | The incidence of 1) DVT 2) myocardial ischemia/infarction 3) urinary tract infection 4) stroke 5) wound infection will be compared between delirium and non-delirium group. Positive CAM-ICU result and confirmed DSM-V criteria will be used to diagnose delirium | 7 days |
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| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |