Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia

Mahidol University

Status: Unknown

Conditions: Postoperative Delirium

Treatments: Drug: Propofol; Drug: Dexmedetomidine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03120442

051/2560(EC2)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 3 patient groups

Propofol-fentanyl

Experimental group

Description:

Fentanyl 0.5 mcg/kg Propofol Target-controlled infusion to achieve MOAA/S 3-4 as end point of sedation Bispectral index (BIS) monitoring

Treatment:

Drug: Fentanyl

Drug: Propofol

Dexmedetomidine

Experimental group

Description:

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

Treatment:

Drug: Fentanyl

Drug: Dexmedetomidine

Fentanyl

Experimental group

Description:

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

Treatment:

Drug: Fentanyl