Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia: a Comparison Between Intraoperative Sedation With Fentanyl, Fentanyl-dexmedetomidine and Fentanyl-propofol
Overview
- Phase
- Not Applicable
- Intervention
- Propofol
- Conditions
- Postoperative Delirium
- Sponsor
- Mahidol University
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Incidence of postoperative delirium
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
* 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.
Investigators
patcharee sriswasdi
MD, MPH
Mahidol University
Eligibility Criteria
Inclusion Criteria
- •Age 65 year or older
- •Scheduled for elective primary total knee arthroplasty
Exclusion Criteria
- •Contraindication for spinal anesthesia
- •Contraindication for adductor canal block
- •Allergy to fentanyl or propofol or dexmedetomidine or bupivacaine
- •Cognitive impairment
- •NSQIP database risk calculator \> 10% overall complication
- •Unable to communicate in Thai language
- •Significant visual and hearing impairment
Arms & Interventions
Propofol-fentanyl
Fentanyl 0.5 mcg/kg Propofol Target-controlled infusion to achieve MOAA/S 3-4 as end point of sedation Bispectral index (BIS) monitoring
Intervention: Propofol
Propofol-fentanyl
Fentanyl 0.5 mcg/kg Propofol Target-controlled infusion to achieve MOAA/S 3-4 as end point of sedation Bispectral index (BIS) monitoring
Intervention: Fentanyl
Dexmedetomidine
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
Intervention: Dexmedetomidine
Dexmedetomidine
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
Intervention: Fentanyl
Fentanyl
Fentanyl 0.5 mcg/kg Supplemental dosage of fentanyl for intraoperative anxiolysis
Intervention: Fentanyl
Outcomes
Primary Outcomes
Incidence of postoperative delirium
Time Frame: Up to 7 days
Positive CAM-ICU result and confirmed DSM-V criteria for delirium
Secondary Outcomes
- The effect of age on the incidence of postoperative delirium(Up to 7 days)
- Inflammatory biomarker(2 days)
- The effect of ASA-physical status on the incidence of postoperative delirium(Up to 7 days)
- The effect of cerebrovascular disease on the incidence of postoperative delirium(Up to 7 days)
- The effect of liver disease on the incidence of postoperative delirium(Up to 7 days)
- The effect of intraoperative blood transfusion and blood loss on the incidence of postoperative delirium(7 days)
- The effect of delirium on postoperative complications.(7 days)
- The effect of Apolipoprotein genotype on the incidence of postoperative delirium(Up to 7 days)
- The effect of delirium on inflammatory biomarker levels(Up to 7 days)
- The effect of chronic kidney disease on the incidence of postoperative delirium(Up to 7 days)
- The effect of postoperative pain on the incidence of postoperative delirium(Up to 7 days)
- The effect of delirium on hospital length of stay(7 days)
- Apolipoprotein genotype(1 days)
- The effect of alcohol consumption on the incidence of postoperative delirium(Up to 7 days)
- The effect of cognitive inpairment on the incidence of postoperative delirium(Up to 7 days)
- The effect of coronary artery disease on the incidence of postoperative delirium(Up to 7 days)
- The effect of diabetes mellitus on the incidence of postoperative delirium(Up to 7 days)
- The effect of gender on the incidence of postoperative delirium(Up to 7 days)
- The effect of delirium on postoperative rehabilitation(7 days)
- The effect of hypertension on the incidence of postoperative delirium(Up to 7 days)
- The effect of intraoperative BIS value on the incidence of postoperative delirium(7 days)