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Trial record 2 of 6 for:    20042557 [PUBMED-IDS]

Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia

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ClinicalTrials.gov Identifier: NCT03120442
Recruitment Status : Enrolling by invitation
First Posted : April 19, 2017
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
patcharee sriswasdi, Mahidol University

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.


Condition or disease Intervention/treatment Phase
Postoperative Delirium Drug: Propofol Drug: Dexmedetomidine Drug: Fentanyl Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia: a Comparison Between Intraoperative Sedation With Fentanyl, Fentanyl-dexmedetomidine and Fentanyl-propofol
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Propofol
target-controlled infusion starting for Cet 0.1 mcg/ml to achieve MOAA/S 3-4

Drug: Fentanyl
0.25 mcg fo Fentanyl for anxiolysis

Experimental: 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
Drug: Dexmedetomidine
Incremental titration of dexmedetomidine starting from 0.1 mcg/kg/hr to achieve MOAA/S 3-4

Drug: Fentanyl
0.25 mcg fo Fentanyl for anxiolysis

Experimental: Fentanyl
Fentanyl 0.5 mcg/kg Supplemental dosage of fentanyl for intraoperative anxiolysis
Drug: Fentanyl
0.25 mcg fo Fentanyl for anxiolysis




Primary Outcome Measures :
  1. Incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    Positive CAM-ICU result and confirmed DSM-V criteria for delirium


Secondary Outcome Measures :
  1. The effect of age on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    Positive CAM-ICU result and confirmed DSM-V criteria for delirium between age 65-75, 75-85, and >85 years of age

  2. Apolipoprotein genotype [ Time Frame: 1 days ]
    ApoE epsilon subtype analysis

  3. The effect of Apolipoprotein genotype on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    ApoE epsilon subtype analysis

  4. Inflammatory biomarker [ Time Frame: 2 days ]
    Preoperative and postoperative comparison of inflammatory biomarker (IL-1, IL-6 TNF, S100b protein)

  5. The effect of delirium on inflammatory biomarker levels [ Time Frame: Up to 7 days ]
    Preoperative and postoperative comparison of inflammatory biomarker (IL-1, IL-6 TNF, S100b protein) comparison between delirium and non-delirium group

  6. The effect of gender on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    Positive CAM-ICU result and confirmed DSM-V criteria for delirium between male and female

  7. The effect of ASA-physical status on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    Positive CAM-ICU result and confirmed DSM-V criteria for delirium between ASA-PS I-II and III-IV

  8. The effect of alcohol consumption on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    Positive CAM-ICU result and confirmed DSM-V criteria for delirium between amount of alcohol consumption (standard drink/day)

  9. The effect of cognitive inpairment on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    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

  10. The effect of coronary artery disease on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    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.

  11. The effect of cerebrovascular disease on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    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.

  12. The effect of chronic kidney disease on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    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.

  13. The effect of liver disease on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    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.

  14. The effect of hypertension on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    Positive CAM-ICU result and confirmed DSM-V criteria for delirium between patients with and without hypertension. Preoperative diagnosis of hypertension will be used.

  15. The effect of diabetes mellitus on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    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.

  16. The effect of postoperative pain on the incidence of postoperative delirium [ Time Frame: Up to 7 days ]
    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.

  17. The effect of intraoperative BIS value on the incidence of postoperative delirium [ Time Frame: 7 days ]
    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

  18. The effect of intraoperative blood transfusion and blood loss on the incidence of postoperative delirium [ Time Frame: 7 days ]
    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

  19. The effect of delirium on hospital length of stay [ Time Frame: 7 days ]
    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

  20. The effect of delirium on postoperative rehabilitation [ Time Frame: 7 days ]
    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

  21. The effect of delirium on postoperative complications. [ Time Frame: 7 days ]
    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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120442


Locations
Thailand
Siriraj Hospital
Bangkok noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University

Publications:

Responsible Party: patcharee sriswasdi, MD, MPH, Mahidol University
ClinicalTrials.gov Identifier: NCT03120442     History of Changes
Other Study ID Numbers: 051/2560(EC2)
First Posted: April 19, 2017    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by patcharee sriswasdi, Mahidol University:
postoperative delirium
total knee arthroplasty
propofol
dexmedetomidine
fentanyl
inflammatory response
interleukins
CAM-ICU

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Propofol
Dexmedetomidine
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Adjuvants, Anesthesia