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.
* In this randomized controlled trial, the investigator will compare the incidence of postoperative delirium after total knee arthroplasty between 3 intraoperative sedation regimens including (1) propofol-fentanyl (2) dexmedetomidine -fentanyl (3) fentanyl alone * Anesthesia techniques include spinal anesthesia and adductor canal block for postoperative analgesia. Sedation will be provide per group assignment. * After performance of regional anesthesia, sedation protocols will be used as followed: (1) target-controlled infusion of Propofol to achieve MOAA/S of 3-4 (2) incremental titration of Dexmedetomidine to achieve MOAA/S of 3-4 (3) supplemental fentanyl for anxiolysis. * Delirium will be screened by trained physicians, registered nurses every 8 hours postoperatively with validated Thai-version CAM-ICU (Confusion Assessment Method-Intensive Care Unit) until patient discharge. * Serum Interleukins (IL-1, IL-6) Tumor necrosis factor-Alpha and S100B protein from preoperative period will be compared with serum from postoperative period between delirium and non-delirium group. The level of serum biomarkers will be acquired in a 6-hour interval for 5 measurement points during the first postoperative day in the first 12 participants. The subsequent participants will have 1 measurement of serum biomarker during the first postoperative day. * Genetic profile for ApolipoproteinE genotype will be acquired and compared between delirium and non-delirium group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
600
target-controlled infusion starting for Cet 0.1 mcg/ml to achieve MOAA/S 3-4
Incremental titration of dexmedetomidine starting from 0.1 mcg/kg/hr to achieve MOAA/S 3-4
0.25 mcg fo Fentanyl for anxiolysis
Siriraj Hospital
Bangkok Noi, Bangkok, Thailand
Incidence of postoperative delirium
Positive CAM-ICU result and confirmed DSM-V criteria for delirium
Time frame: Up to 7 days
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
Time frame: Up to 7 days
Apolipoprotein genotype
ApoE epsilon subtype analysis
Time frame: 1 days
The effect of Apolipoprotein genotype on the incidence of postoperative delirium
ApoE epsilon subtype analysis
Time frame: Up to 7 days
Inflammatory biomarker
Preoperative and postoperative comparison of inflammatory biomarker (IL-1, IL-6 TNF, S100b protein)
Time frame: 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
Time frame: 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
Time frame: Up to 7 days
The effect of ASA-physical status on the incidence of postoperative delirium
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Positive CAM-ICU result and confirmed DSM-V criteria for delirium between ASA-PS I-II and III-IV
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 7 days