Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia

Postoperative Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03120442
• Other study ID #: 051/2560(EC2)
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 14, 2017
• Est. completion date: August 2022

Study information

• Verified date: September 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 600
• Est. completion date: August 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Drug:
• Propofol
target-controlled infusion starting for Cet 0.1 mcg/ml to achieve MOAA/S 3-4
• Dexmedetomidine
Incremental titration of dexmedetomidine starting from 0.1 mcg/kg/hr to achieve MOAA/S 3-4
• Fentanyl
0.25 mcg fo Fentanyl for anxiolysis

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative delirium	Positive CAM-ICU result and confirmed DSM-V criteria for delirium	Up to 7 days
Secondary	The effect of age on the incidence of postoperative delirium	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
Secondary	Apolipoprotein genotype	ApoE epsilon subtype analysis	1 days
Secondary	The effect of Apolipoprotein genotype on the incidence of postoperative delirium	ApoE epsilon subtype analysis	Up to 7 days
Secondary	Inflammatory biomarker	Preoperative and postoperative comparison of inflammatory biomarker (IL-1, IL-6 TNF, S100b protein)	2 days
Secondary	The effect of delirium on inflammatory biomarker levels	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
Secondary	The effect of gender on the incidence of postoperative delirium	Positive CAM-ICU result and confirmed DSM-V criteria for delirium between male and female	Up to 7 days
Secondary	The effect of ASA-physical status on the incidence of postoperative delirium	Positive CAM-ICU result and confirmed DSM-V criteria for delirium between ASA-PS I-II and III-IV	Up to 7 days
Secondary	The effect of alcohol consumption on the incidence of postoperative delirium	Positive CAM-ICU result and confirmed DSM-V criteria for delirium between amount of alcohol consumption (standard drink/day)	Up to 7 days
Secondary	The effect of cognitive inpairment on the incidence of postoperative delirium	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
Secondary	The effect of coronary artery disease on the incidence of postoperative delirium	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
Secondary	The effect of cerebrovascular disease on the incidence of postoperative delirium	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
Secondary	The effect of chronic kidney disease on the incidence of postoperative delirium	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
Secondary	The effect of liver disease on the incidence of postoperative delirium	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
Secondary	The effect of hypertension on the incidence of postoperative delirium	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
Secondary	The effect of diabetes mellitus on the incidence of postoperative delirium	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
Secondary	The effect of postoperative pain on the incidence of postoperative delirium	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
Secondary	The effect of intraoperative BIS value on the incidence of postoperative delirium	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
Secondary	The effect of intraoperative blood transfusion and blood loss on the incidence of postoperative delirium	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
Secondary	The effect of delirium on hospital length of stay	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
Secondary	The effect of delirium on postoperative rehabilitation	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
Secondary	The effect of delirium on postoperative complications.	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