Investigating the effect of caffeine in increasing the level of consciousness of patients with benzodiazepine poisoning who referred to Loghman Hakim Hospital in from March to June 2024
Defining a standard method for improving the consciousness of poisoned patients in cases where the consciousness of patients does not increase with usual treatments.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized using the Random Number Generator v1.4 program - phase 3 on 60 patients
Settings and conduct
The intervention group is the group that is prescribed caffeine and flumazenil for their treatment. The control group is the group that only flumazenil is prescribed for their treatment. Their tests were done before the study, such as urine screen test, and recorded in the researcher's checklist. The information is collected and entered into the SPSS system and software and is scientifically analyzed by a statistical consultant. Location: Loqman Hakim hospital-Blinding of the nurse giving the drug to the identical placebo drug and analyzer will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: people over 14 years of age whose poisoning with benzodiazepines has been confirmed through the urine toxicology screen of the patient and have a reduced level of consciousness so that the GCS is less than 13 and have no contraindications to receive flumazenil, no head trauma, and no accompanying poisoning. Exclusion criteria in each group: sensitivity to caffeine and underlying metabolic, neurological, aspiration disease
Intervention groups
Intervention group: caffeine at a dose of 100 mg and once every 8 hours and flumazenil at a dose of 200 microns and once every hour along with 5% dextrose serum until waking up. Control group: patients poisoned with benzodiazepines who received flumazenil at a dose of 200 microns warm and receive 5% dextrose serum every one hour until waking up
Main outcome variables
Level of consciousness; duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091116002717N2
Registration date:2024-04-03, 1403/01/15
Registration timing:registered_while_recruiting
Last update:2024-04-03, 1403/01/15
Update count:0
Registration date
2024-04-03, 1403/01/15
Registrant information
Name
Babak Mostafazadeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5540 9534
Email address
mstzbmd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of caffeine in increasing the level of consciousness of patients with benzodiazepine poisoning who referred to Loghman Hakim Hospital in from March to June 2024
Public title
Investigating the effect of caffeine in increasing the level of consciousness of patients with benzodiazepine poisoning
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 14 years old
Benzodiazepine poisoning has been confirmed through the urine toxicology screen of the patient
Loss of consciousness
GCS less than 13
No head trauma
Do not have any contraindications to receiving flumazenil
No accompanying poisoning
Exclusion criteria:
Age below 14 years
Not having a positive urine screen for benzodiazepines
No loss of consciousness
GCS 14 15
Having head trauma
Having a contraindication to receiving flumazenil
Having accompanying poisoning
Allergy to caffeine
Having underlying metabolic disease
Age
From 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using the Random Number Generator v1.4 computer program, so that as soon as the patient enters the relevant department, a random number between 1 and 60 will be requested, which will be assigned to the patient if the patient has an even number. He will be included in the control group and if the patient has an odd number, he will be included in the study group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Each dose of medicine is individually packaged and has an identification number. Drug and placebo boxes are supplied in completely similar appearance and packaging, which will cause blinding of participants, researchers and outcome assessors.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti Medical University
Street address
Shahid Beheshti University of Medical Sciences, Arabi St., Daneshjou Blvd,. Velenjak
City
Tehran
Province
Tehran
Postal code
193954631
Approval date
2024-03-05, 1402/12/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.811
Health conditions studied
1
Description of health condition studied
Benzodiazepine poisoning
ICD-10 code
T42.4
ICD-10 code description
Poisoning by, adverse effect of and underdosing of benzodiazepines
Primary outcomes
1
Description
Level of consciousness
Timepoint
Every 8 hours
Method of measurement
GCS
Secondary outcomes
1
Description
The patient's time to wake up after receiving the first dose of caffeine
Timepoint
After administration of the first dose of caffeine and then every 24 hours
Method of measurement
hours and every 24 hours is considered a day
Intervention groups
1
Description
Intervention group: Caffeine with a dose of 100 mg and once every 8 hours and flumazenil with a dose of 200 microns and once every hour along with 5% dextrose serum.
Category
Treatment - Drugs
2
Description
Control group: Patients poisoned with benzodiazepines who receive flumazenil at a dose of 200 micrograms every one hour with 5% dextrose serum until waking up.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Hospital
Full name of responsible person
Babak Mosftafa zade
Street address
Loghman Hakim Hospital-Makhsous Ave-District 10-Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Email
loghman.hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Chamran Highway - Yemen Street - Shahid Abbas Arabi Street (Parvaneh) - next to Taleghani Hospital - Shahid Beheshti University of Medical Sciences and Healthcare Services - Headquarters Building 2- 5th floor - Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
193954631
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
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
Babak Mosftafa zade
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Loghman Hakim Hospital-Makhsous Ave-District 10-Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Email
mstzbmd@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Babak Mosftafa zade
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Loghman Hakim Hospital-Makhsous Ave-District 10-Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Email
mstzbmd@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Babak Mosftafa zade
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Toxicology
Street address
Loghman Hakim Hospital-Makhsous Ave-District 10-Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5102 5000
Email
mstzbmd@sbmu.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
All data can be shared
When the data will become available and for how long
Always available
To whom data/document is available
All researchers
Under which criteria data/document could be used
Do more research
From where data/document is obtainable
Loqhman Hakim Hospital - Poisoning Research Center
What processes are involved for a request to access data/document