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

Effect of Different Doses of Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Elective Total Knee Arthroplasty Under Spinal Anesthesia: A Pilot Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05707741
Enrollment
45
Registered
2023-02-01
Start date
2023-06-01
Completion date
2024-02-20
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Keywords

Delirium , Dexmetomedine

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

Detailed description

On the day of surgery and after arrival to the theatre, all patients will have supplemental oxygen by nasal cannula at 5 L min-1 and will be connected to the standard monitoring non-invasive blood pressure, electrocardiography, and pulse oximetry. crystalloid 10mg/kg will be administered then all patients will receive spinal anaesthesia in the sitting position, under complete aseptic technique. The midline or Para median spinal puncture will be performed. volume of 3 ml of hyperbaric bupivacaine (Marcaine® Spinal Heavy 0.5%, AstraZeneca) will be injected using a 25 G spinal needle . After establishment of spinal anesthesia , A loading dose of dexmetomedine (1 µg/kg) will be administered for 10 min for all the patients then Three types of syringes will be prepared on 50 ml syringes Group A: saline 50 ml, Group B: a 50 ml mixture of saline 49 ml and dexmedetomidine 100 μg, and Group C: a 50 ml mixture of saline 48 ml and dexmedetomidine 200 μg. the patients then they will be randomized into 3 groups

Interventions

DRUGdexmetomedine infusion

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

DRUGDexmetomedine infusion

50 ml mixture of saline 48 ml and dexmedetomidine 200 μg

DRUGPlacebo

Normal saline infusion

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

prospective randomized trial

Eligibility

Sex/Gender
ALL
Age
65 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
cognitive functions3 daysConfusion Assessment Method (CAM)

Secondary

MeasureTime frameDescription
Post operative pain3daysVAS (0\_10)
Sedation3daysRamsay sedation score

Countries

Egypt

Contacts

PRINCIPAL_INVESTIGATORrabab M habeeb, Dr

Menoufia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026