Comparison of the effect of oral caffeine pills compared to placebo in the prevention of postoprative delirium in surgical patients admitted to intensive care unit.
Determining and comparing the effect of oral caffeine compared to placebo in preventing delirium in surgical patients admitted to intensive care unit.
Design
A clinical trial with a control group (placebo), with parallel groups, double-blind, randomized, phase 3
Settings and conduct
Patients are divided into two groups using a table of random numbers generated by the computer. Then, each patient is assigned a code, and each code is equivalent to an envelope containing study pills. The envelope containing the pills is opaque and sealed and will be opened at the patient's bedside after assigning the code to the patient. The tablets are identical in shape and size.
The patients, the researcher (special care assistant) responsible for registering the patients' information and responsible for the statistical analysis of the contents of the codes and envelopes are not aware. Only the principal investigator knows the contents of the envelopes and the matching of the codes.
Participants/Inclusion and exclusion criteria
Inclusion: Patients 18 to 75 years old who have surgical cases (major surgeries: abdominal surgery and urology orthopedics). Exclusion: Patients should have no known arrhythmia, kidney and liver failure, history of seizures.
Intervention groups
Patients in intervention group will receive a 200 mg caffeine tablet every 12 hours for 3 days. In the placebo pill control group, they will receive a placebo pill every 12 hours for 3 days.
Main outcome variables
Delirium in the first 3 days after admission to the intensive care unit.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210523051374N1
Registration date:2024-07-26, 1403/05/05
Registration timing:registered_while_recruiting
Last update:2024-07-26, 1403/05/05
Update count:0
Registration date
2024-07-26, 1403/05/05
Registrant information
Name
Babak Moayer
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8523
Email address
moayer-b@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-03, 1403/03/14
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of oral caffeine pills compared to placebo in the prevention of postoprative delirium in surgical patients admitted to intensive care unit.
Public title
Caffeine pills in the prevention of postoperative delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 75 years
Postoperative surgical ICU patients (major surgeries: abdominal surgery and urology orthopedics)
Patient consent to participate in the study
Exclusion criteria:
Patients with known arrhythmia
Patients with advanced liver and kidney failure
Burn and trauma cases and heart surgery patients
Pregnancy
Morbid obese patients (body mass index greater than 40 or weight greater than 130 kg)
Patients with known seizures
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into two groups using a table of random numbers generated by the computer (excel software using Rand function generated numbers between 1 t0 100). Random numbers will assign patients to the control or intervention group based on the ratio of 1 to 3. Then, each patient is assigned a code, and each code is equivalent to an envelope containing study pills. The envelope containing the pills is opaque and sealed and will be opened at the patient's bedside after assigning the code to the patient. The tablets are identical in shape and size.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person responsible for postoperative delirium evaluation, patients and the person responsible for statistical analysis do not know about the patients group assignment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran Province, Tehran, District 6, Pour Sina St, Iran
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.521
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Delirium
Timepoint
3 days post-ICU admission
Method of measurement
Confusion assessment method for ICU (CAM-ICU)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Caffeine group 200 mg each 12 hours for 5 days, Karen Pharmaceutical Company
Category
Prevention
2
Description
Control group: Placebo group 1pill each 12 hours for 5 days, Karen Pharmaceutical Company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Babak Moayer
Street address
Keshavarz Blvd. Gharib St. Imam Khomeini Hospital.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
moayer.babak@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Rezaee
Street address
Qods St, Poor sina St, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 6640 5357
Email
deanmed@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Babak Moayer
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital, Imam Khomeini Ave, Hasan Abad, Tehran Town
City
Tehran
Province
Tehran
Postal code
11365-3876
Phone
+98 21 6634 8523
Fax
Email
moayer-b@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Moayer
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital, Imam Khomeini Ave, Hasan Abad, Tehran Town
City
Tehran
Province
Tehran
Postal code
11365-3876
Phone
+98 21 6634 8523
Fax
Email
moayer-b@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Moayer
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Sina Hospital, Imam Khomeini Ave, Hasan Abad, Tehran Town
City
Tehran
Province
Tehran
Postal code
11365-3876
Phone
+98 21 6634 8523
Fax
Email
moayer-b@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data will be coded and will be shared.
When the data will become available and for how long
Starting in March 2025
To whom data/document is available
Researcher working in academic institutions.
Under which criteria data/document could be used
N/A
From where data/document is obtainable
Email Dr Moayer.
What processes are involved for a request to access data/document
Email should be sent from an academic institutions and 2 months will be lasted from sending email and getting data.