Dexmetomedine for Post Operative Delirium in Elderly Patients Undergoing Elective Total Knee Replacement Under Spinal Anesthesia

NCT05707741 | Completed

• 1 other identifier: 1/2023,ANET2-2
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium is a geriatric syndrome occurring after anesthesia and surgery which manifests as acute alterations in mental status, involving changes in cognition, attention, and levels of consciousness that tend to fluctuate The use of dexmedetomidine with the intention to prevent postoperative delirium remains controversial. Where it has shown to be effective in older adult patients undergoing cardiovascular and non-cardiovascular surgeries

Conditions

Postoperative Delirium

Keywords

Delirium , Dexmetomedine

Outcome Measures

Primary Outcomes (1)

• cognitive functions

  Confusion Assessment Method (CAM)

  3 days

Secondary Outcomes (2)

• Post operative pain

  3days

• Sedation

  3days

Study Arms (3)

Group A

PLACEBO COMPARATOR

normal saline infusion rate 0.4uq/kg /hour

Drug: dexmetomedine infusion

Group B

ACTIVE COMPARATOR

dexmetomedine 0.2 µg/kg/hr

Drug: dexmetomedine infusion

Group C

ACTIVE COMPARATOR

dexmetomedine 0.4 µg/kg/hr

Drug: dexmetomedine infusion

Interventions

Dexmetomedine infusion DRUG

50 ml mixture of saline 49 ml and dexmedetomidine 100 μg,

Group A; Group B; Group C

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• ASA physical status I- II
• Age from 65to 75 years old,
• Elective total knee arthroplasty under spinal anaesthesia.

You may not qualify if:

• Bleeding disorders
• Allergy to any of the drugs used in the study
• Renal insufficiency
• Liver failure-Neurological abnormalities -patients with hearing and visual impairment

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Menoufia, Menoufia, 32817, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• rabab M habeeb, Dr

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: prospective randomized trial

Study Record Dates

• First Submitted: January 22, 2023
• First Posted: February 1, 2023
• Study Start: June 1, 2023
• Primary Completion: February 2, 2024
• Study Completion: February 20, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)