An interventional study of Propofol and Dexmedetomidine in Postoperative Delirium, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by Mahidol University · Not applicable, Interventional, and Prevention
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's planned enrollment of 600 is above the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fentanyl 0.5 mcg/kg Propofol Target-controlled infusion to achieve MOAA/S 3-4 as end point of sedation Bispectral index (BIS) monitoring
Drug: Propofol · Drug: Fentanyl
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
Drug: Dexmedetomidine · Drug: Fentanyl
Fentanyl 0.5 mcg/kg Supplemental dosage of fentanyl for intraoperative anxiolysis
Drug: Fentanyl
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
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
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
Plan to share: Undecided
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Mahidol University