Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia

NCT03120442 | Unknown

• 1 other identifier: 051/2560(EC2)
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Delirium

Keywords

postoperative delirium; total knee arthroplasty; propofol; dexmedetomidine; fentanyl; inflammatory response; interleukins; CAM-ICU

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  Positive CAM-ICU result and confirmed DSM-V criteria for delirium

  Up to 7 days

Secondary Outcomes (21)

• The effect of age on the incidence of postoperative delirium

  Up to 7 days

• Apolipoprotein genotype

  1 days

• The effect of Apolipoprotein genotype on the incidence of postoperative delirium

  Up to 7 days

• Inflammatory biomarker

  2 days

• The effect of delirium on inflammatory biomarker levels

  Up to 7 days

Study Arms (3)

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

Drug: Propofol; Drug: Fentanyl

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

Drug: Dexmedetomidine; Drug: Fentanyl

Fentanyl

EXPERIMENTAL

Fentanyl 0.5 mcg/kg Supplemental dosage of fentanyl for intraoperative anxiolysis

Drug: Fentanyl

Interventions

Propofol DRUG

target-controlled infusion starting for Cet 0.1 mcg/ml to achieve MOAA/S 3-4

Propofol-fentanyl

Dexmedetomidine DRUG

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

Dexmedetomidine

Fentanyl DRUG

0.25 mcg fo Fentanyl for anxiolysis

Dexmedetomidine; Fentanyl; Propofol-fentanyl

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 year or older
• Scheduled for elective primary total knee arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (32)

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MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol; Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: April 15, 2017
• First Posted: April 19, 2017
• Study Start: June 14, 2017
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

TH (1)