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

Primary Purpose

Postoperative Delirium is a Geriatric

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

dexmetomedine infusion

Dexmetomedine infusion

About this trial

This is an interventional prevention trial for Postoperative Delirium is a Geriatric focused on measuring Delirium , Dexmetomedine

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesAccepts 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

normal saline infusion rate 0.4uq/kg /hour

dexmetomedine 0.2 µg/kg/hr

dexmetomedine 0.4 µg/kg/hr

Outcomes

Primary Outcome Measures

cognitive functions

Confusion Assessment Method (CAM)

Secondary Outcome Measures

Pain

Visual Analog Score

Sedation

Ramsay sedation score

Full Information

NCT ID

NCT05707741

First Posted

January 22, 2023

Last Updated

January 22, 2023

Sponsor

Menoufia University

1. Study Identification

Unique Protocol Identification Number

NCT05707741

Brief Title

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

Official Title

Feasibility of Different Doses of Dexmetomedine to Prevent Post Operative Delirium in Elderly Patients Undergoing Elective Total Knee Replacement Under Spinal Anesthesia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 1, 2023 (Anticipated)

Primary Completion Date

August 2, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Delirium is a Geriatric

Keywords

Delirium , Dexmetomedine

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

prospective randomized trial

Masking

Investigator

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Placebo Comparator

Arm Description

normal saline infusion rate 0.4uq/kg /hour

Arm Title

Group B

Arm Type

Active Comparator

Arm Description

dexmetomedine 0.2 µg/kg/hr

Arm Title

Group C

Arm Type

Active Comparator

Arm Description

dexmetomedine 0.4 µg/kg/hr

Intervention Type

Drug

Intervention Name(s)

dexmetomedine infusion

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmetomedine infusion

Intervention Description

50 ml mixture of saline 48 ml and dexmedetomidine 200 μg

Primary Outcome Measure Information:

Title

cognitive functions

Description

Confusion Assessment Method (CAM)

Time Frame

3 days

Secondary Outcome Measure Information:

Title

Pain

Description

Visual Analog Score

Time Frame

3days

Title

Sedation

Description

Ramsay sedation score

Time Frame

3days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

rabab M habeeb

Phone

+201001970973

rababhabeeb39@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

rabab M habeeb, Dr

Organizational Affiliation

Menofia University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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