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

August 22, 2026 updated by: rabab Mohammad habeeb, Menoufia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

45

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

  • Egypt
    • Menoufia
      • Menoufia, Menoufia, Egypt, 32817
        • Menoufia University

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 to 75 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group B
dexmetomedine 0.2 µg/kg/hr
Drug: dexmetomedine infusion
50 ml mixture of saline 49 ml and dexmedetomidine 100 μg,
Active Comparator: Group C
dexmetomedine 0.4 µg/kg/hr
Drug: dexmetomedine infusion
50 ml mixture of saline 49 ml and dexmedetomidine 100 μg,
Placebo Comparator: Group A
normal saline infusion
Drug: Placebo
Normal saline infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive functions
Time Frame: 3 days
Confusion Assessment Method (CAM)
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation
Time Frame: 3days
Ramsay sedation score
3days
Post operative pain
Time Frame: 3days
VAS (0_10)
3days

Collaborators and Investigators

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

Sponsor

Menoufia University

Investigators

  • Principal Investigator: rabab M habeeb, Dr, Menoufia University

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 1, 2023

Primary Completion (Actual)

February 2, 2024

Study Completion (Actual)

February 20, 2024

Study Registration Dates

First Submitted

January 22, 2023

First Submitted That Met QC Criteria

January 22, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 22, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2023,ANET2-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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