Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia

September 20, 2021 updated by: patcharee sriswasdi, Mahidol University

Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia: a Comparison Between Intraoperative Sedation With Fentanyl, Fentanyl-dexmedetomidine and Fentanyl-propofol

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok noi, Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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: Fentanyl
0.25 mcg fo Fentanyl for anxiolysis
Drug: Dexmedetomidine
Incremental titration of dexmedetomidine starting from 0.1 mcg/kg/hr to achieve MOAA/S 3-4
EXPERIMENTAL: Fentanyl
Fentanyl 0.5 mcg/kg Supplemental dosage of fentanyl for intraoperative anxiolysis
Drug: Fentanyl
0.25 mcg fo Fentanyl for anxiolysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative delirium
Time Frame: Up to 7 days
Positive CAM-ICU result and confirmed DSM-V criteria for delirium
Up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 7 days
Apolipoprotein genotype
Time Frame: 1 days
ApoE epsilon subtype analysis
1 days
The effect of Apolipoprotein genotype on the incidence of postoperative delirium
Time Frame: Up to 7 days
ApoE epsilon subtype analysis
Up to 7 days
Inflammatory biomarker
Time Frame: 2 days
Preoperative and postoperative comparison of inflammatory biomarker (IL-1, IL-6 TNF, S100b protein)
2 days
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
Up to 7 days
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
Up to 7 days
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
Up to 7 days
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)
Up to 7 days
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
Up to 7 days
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.
Up to 7 days
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.
Up to 7 days
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.
Up to 7 days
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.
Up to 7 days
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.
Up to 7 days
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.
Up to 7 days
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.
Up to 7 days
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
7 days
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
7 days
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
7 days
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
7 days
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 14, 2017

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

April 15, 2017

First Submitted That Met QC Criteria

April 15, 2017

First Posted (ACTUAL)

April 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051/2560(EC2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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