Investigating the effect of transcranial direct current on the prevention of delirium after surgery in cardiac surgery patients
Design
The clinical trial has a control group with parallel groups, double-blind, without phase on 60 patients. Patients are randomly divided into two groups (online randomization). 30 people in the ACTIVE-TDCS or intervention group: in this group of patients, two daily brain stimulation sessions from the first day after surgery for 3 consecutive days, each session is about It takes 20 minutes and there is at least 8 hours between them. 30 people in the SHAM-TDCS or control group: receiving the simulated stimulus program.
Settings and conduct
After open heart surgery, patients admitted to the Cardiac ICU of Modares Hospital are randomly divided into two groups: in the ACTIVE-TDCS group, a direct stimulation current of 2 milliamps will be applied in the right prefrontal region. The study is double-blind, and the patient and delirium outcome assessor will be blinded to the type of intervention.
Participants/Inclusion and exclusion criteria
inclusion criteria:
1. Adults who are over 18 years old
2. Patients who have undergone open heart surgery with CPB
3. Patient satisfaction
exclusion criteria:
1. A history of progressive brain disease or dementia or psychiatric illness that affects cognition
2. History of epilepsy, seizure or syncope
3. Brain damage already known
4. Heart pacemaker or any metal device implanted in the body
5. Use of neuropsychological drugs in the pre-operative period
6. Patients with a history of drug or alcohol addiction
Intervention groups
ACTIVE-TDCS or intervention group: two daily sessions of brain stimulation from the first day after surgery for 3 consecutive days.
SHAM-TDCS or control group: receiving the simulated stimulus program
Main outcome variables
Occurrence of postoperative delirium during the first three days after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230626058586N5
Registration date:2024-07-22, 1403/05/01
Registration timing:prospective
Last update:2024-07-22, 1403/05/01
Update count:0
Registration date
2024-07-22, 1403/05/01
Registrant information
Name
Nasim Sohrabifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 229 6766
Email address
nasimsohrabifar@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2026-02-20, 1404/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of transcranial direct current (TDCS) on the prevention of post-operative delirium in elderly patients undergoing cardiac surgery
Public title
Investigating the effect of TDCS on delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
Patients undergoing CPB open heart surgery
Consent to participate in the study
Exclusion criteria:
A history of progressive brain disease or dementia or psychiatric illness that affects cognition
History of epilepsy, seizures or syncope
Pre-existing brain injury
Heart pacemaker or any metal device implanted in the body
Use of neuropsychological drugs in the preoperative period
Patients with a history of drug or alcohol addiction
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The website www.Randomization.com will be used for randomization (online randomization). After determining the number of intervention groups, which are two groups, and the required number in each of these groups, the website will provide us with a random table of numbers that will represent the patient's number. Then the random sequence is available to the researcher. The researcher performs the desired intervention based on the order in which the participants entered the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Although the patient will be given sufficient explanations about the study process before the surgery and the patient's consent will be obtained, the patient will not know exactly whether he is in the intervention or control group. The researcher, doctors, nurses and caregivers of the operating room will be aware of the group in which the patient is. The person assessing the final outcome, i.e. delirium and cognitive function after the operation, will also be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Ethics Committee of Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Velenjak st., Tehran.
City
Tehran
Province
Tehran
Postal code
1995825466
Approval date
2024-06-23, 1403/04/03
Ethics committee reference number
IR.SBMU.RETECH.REC.1403.125
Health conditions studied
1
Description of health condition studied
Postoperative delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Occurrence of postoperative delirium during the first three days after surgery
Timepoint
Delirium is checked and recorded at least 2 hours after the end of surgery and 2 times a day during the first three days after surgery with a minimum time interval of 6 hours.
Method of measurement
By the CAM-ICU tool (method of assessment of confusion in the ICU department)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group of patients, he receives two daily sessions of brain stimulation from the first day after the surgery for 3 consecutive days, each session lasts about 20 minutes and there is at least 8 hours between them. A direct stimulation current of 2 mA (right anode/left cathode) will be applied to the right prefrontal region.
Category
Prevention
2
Description
Control group: Control group: receiving the simulated stimulus program, TDCS, the same specifications are used that a simulated stimulus similar to the active stimulus will be used. In this group, all cases are observed in the same way as the intervention group, except that only 30 seconds of RAM is established at the beginning and end of the electrode connection and the current of 1-2 milliamps will not be established.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres hospital
Full name of responsible person
Dr. Marziye Shahrabi
Street address
Shahid Modares Hospital, Saadat abad Blvd.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 912 183 6552
Email
shahrabimarzieh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marziye Shahrabi
Street address
Shahid Modarres Hospital, Saadatabad Blvd.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 912 183 6552
Email
shahrabimarzieh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marziye Shahrabi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
ُShahid Modarres Hospital, Saadatabad Blvd.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 912 183 6552
Email
shahrabimarzieh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marziye Shahrabi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
ُShahid Modarres Hospital, Saadatabad Blvd.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 912 183 6552
Email
shahrabimarzieh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marziye Shahrabi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
ُShahid Modarres Hospital, Saadatabad Blvd.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 912 183 6552
Email
shahrabimarzieh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available