Back to resultsPregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting
Primary Purpose
Pregabalin, Delirium Treatment, Coronary Artery Bypass Grafting
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Pregabalin
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Pregabalin
Eligibility Criteria
Inclusion Criteria: CABG patients ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III planned for fast track developed postoperative delirium (POD). Exclusion Criteria: Patients who had history of psychiatric diseases; inability to communicate; previous history of POD; preoperative sick sinus syndrome, allergy/sensitivity to pregabalin or dexmedetomidine, severe bradycardia (heart rate <50 beat per minute), second-degree or above atrioventricular block without pacemaker; severe hepatic or renal insufficiency. Previous cardiac or thoracic surgery, known diagnosis of depression or other major psychiatric diseases, cognitive impairment or inability to cooperate with the study, renal insufficiency, and history of substance abuse.
Sites / Locations
- Islam MorsyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Pregabalin group
Dexmedetomidine group
Arm Description
Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.
Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min) followed by an infusion of 0.2 to 0.7 μg/h.
Outcomes
Primary Outcome Measures
Percent of delirium treatment
Assessment of delirium will be performed preoperatively and postoperatively at 12-h intervals or as needed according to the patient's condition using the confusion assessment method (CAM)
Secondary Outcome Measures
Level of sedation
Sedation level will be assessed by using the Ramsey sedation scale.
Incidence of weaning from mechanical ventilation
percent of patients who weaned from mechanical ventilation
Length of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05640453
Brief Title
Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting
Official Title
Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting: A Randomized Double-Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to determine the effect of pregabalin versus dexmedetomidine on the treatment and lasting duration of delirium in fast tracking elderly patients after Coronary Artery Bypass Grafting.
Detailed Description
Delirium is an acute brain disorder that involves changes in consciousness, attention, cognition, and perception.The incidence of postoperative delirium (POD) is high among patients undergoing cardiac surgery, ranging from 20 to 50%, and the risk is even higher in the elderly.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregabalin, Delirium Treatment, Coronary Artery Bypass Grafting, Dexmedetomidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pregabalin group
Arm Type
Active Comparator
Arm Description
Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.
Arm Title
Dexmedetomidine group
Arm Type
Active Comparator
Arm Description
Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min) followed by an infusion of 0.2 to 0.7 μg/h.
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Patients will receive pregabalin capsules (75 mg) every 12 h for 24 hours by nasogastric tube.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Patients will receive a bolus dose of 0.4 μg/kg dexmedetomidine (over a period of 10 to 20 min)
Primary Outcome Measure Information:
Title
Percent of delirium treatment
Description
Assessment of delirium will be performed preoperatively and postoperatively at 12-h intervals or as needed according to the patient's condition using the confusion assessment method (CAM)
Time Frame
24 hour postoperatively
Secondary Outcome Measure Information:
Title
Level of sedation
Description
Sedation level will be assessed by using the Ramsey sedation scale.
Time Frame
24 hour postoperatively
Title
Incidence of weaning from mechanical ventilation
Description
percent of patients who weaned from mechanical ventilation
Time Frame
1 week postoperatively
Title
Length of hospital stay
Time Frame
1 month postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CABG patients ≥ 65 years of age both genders American Society of Anesthesiologists (ASA) physical status classification II or III planned for fast track developed postoperative delirium (POD).
Exclusion Criteria:
Patients who had history of psychiatric diseases; inability to communicate;
previous history of POD; preoperative sick sinus syndrome, allergy/sensitivity to pregabalin or dexmedetomidine, severe bradycardia (heart rate <50 beat per minute), second-degree or above atrioventricular block without pacemaker; severe hepatic or renal insufficiency.
Previous cardiac or thoracic surgery, known diagnosis of depression or other major psychiatric diseases, cognitive impairment or inability to cooperate with the study, renal insufficiency, and history of substance abuse.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Islam Morsy, MD
Phone
00201093387374
Email
eslam.morsy@med.tanta.edu.eg
Facility Information:
Facility Name
Islam Morsy
City
Tanta
State/Province
El-Gharbia Governorate
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Islam Morsy, MD
Phone
00201093387374
Ext
139
Email
eslam.morsy@med.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
Mohammed S El Sharkawy, MD
First Name & Middle Initial & Last Name & Degree
Hussein G Almawardy, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will available upon reasonable request from the principal investigator
Learn more about this trial
Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting
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