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

Menoufia University

Status: Completed

Conditions: Postoperative Delirium

Treatments: Drug: Dexmetomedine infusion; Drug: dexmetomedine infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05707741

1/2023,ANET2-2

Details and patient eligibility

About

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

Full 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

Enrollment: 45 patients

Sex: All

Ages: 65 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups, including a placebo group

Group A

Placebo Comparator group

Description:

normal saline infusion rate 0.4uq/kg /hour

Treatment:

Drug: dexmetomedine infusion

Group B

Active Comparator group

Description:

dexmetomedine 0.2 µg/kg/hr

Treatment:

Drug: dexmetomedine infusion

Group C

Active Comparator group

Description:

dexmetomedine 0.4 µg/kg/hr

Treatment:

Drug: dexmetomedine infusion