Comparison of the efficacy of ketamine-midazolam combination with midazolam alone in the treatment of status epilepticus resistant to first- and second-line treatments in patients with refractory status epilepticus
Comparison of the effect of ketamine combined with midazolam compared to midazolam alone in reducing complications and mortality, reducing recurrence and shortening the duration of seizures in patients with treatment-resistant status seizures.
Design
The study is a feasibility study and a pilot, and due to the small size of the sample, it will not be done randomly, and it will have two groups of ten people.
Settings and conduct
The study will be conducted at Namazi Hospital in the intensive care unit on patients with status epilepticus who are resistant to first and second line treatment. One study group will be given midazolam alone and the other group will be given midazolam and ketamine. And complications and mortality rates are measured.
Participants/Inclusion and exclusion criteria
Eighteen to fifty-year-old patients with refractory status epilepticus are included in the study, and pregnant people; patients with multi organ failure; patients with high blood pressure or evidence of increased intracranial pressure are excluded from the study.
Intervention groups
For one group, simultaneous treatment with ketamine and midazolam and in the other group, treatment with midazolam alone is used. For the group receiving ketamine, it is important to pay attention to the patient's blood pressure, the absence of high intracerebral pressure and no evidence of acute myocardial ischemia. For the control group, which received midazolam alone. It is important to note that the patient's blood pressure is not low.
Main outcome variables
shortening the duration of a long sustained seizure; reducing the recurrence of seizures; Examination of complications of prolonged seizures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221022056269N1
Registration date:2023-01-28, 1401/11/08
Registration timing:registered_while_recruiting
Last update:2023-01-28, 1401/11/08
Update count:0
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
fateme kiani ara
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4263
Email address
fateme81kiani71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-24, 1401/09/03
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of ketamine-midazolam combination with midazolam alone in the treatment of status epilepticus resistant to first- and second-line treatments in patients with refractory status epilepticus
Public title
effect of midazolam- ketamine combination in refractory status epilepticus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with refractory status epilepticus
Age between 18-50 years ohd
Exclusion criteria:
The pregnant patients
The patients with sepsis
Post hypoxic patients
The patients with multi organ damage
The patients with high blood pressure and increased intracranial pressure
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of medicine-Shiraz university of medical Sciences.
Street address
Namazi Square of Namazi Hospital
City
Shiraz
Province
Fars
Postal code
71936-13311
Approval date
2022-10-02, 1401/07/10
Ethics committee reference number
IR.SUMS.MED.REC.1401.349
Health conditions studied
1
Description of health condition studied
Refractory status epilepticus
ICD-10 code
G96.8
ICD-10 code description
Other disorders of nervous system in diseases classified elsewhere
Primary outcomes
1
Description
Level of consciousness, galasco coma score
Timepoint
The beginning of the study and one hour later and twenty four hours later.
Method of measurement
glasco score coma
2
Description
ststus seizure termination time
Timepoint
one houre later
Method of measurement
Based on the patient's clinical symptoms
Secondary outcomes
1
Description
The secondary outcome variable is the examination of the amount of drug side effects in the two study groups, which is checked based on the patient's clinical symptoms.
Timepoint
At the beginning of the study, the blood pressure and heart rate of the patients and the electrocardiogram of the patients are taken.
Method of measurement
Use of sphygmomanometer and heart rate monitor.
Intervention groups
1
Description
Intervention group: The intervention group of ketamine drug, which is part of the category of anesthetic drugs, in the form of intravenous injection with a dose of 3 mg along with midazolam with a bolus dose of./2 Mg/kg and maintenance dose: starting with ./1 Mg per kilogram of body weight is injected in one minute up to a maximum dose of 2 mg per kilogram of body weight per minute, which is continued for twenty-four hours in case of clinical response.
Category
Treatment - Drugs
2
Description
Control group: the group receiving midazolam alone with a bolus dose of ./2 Mg/kg and maintenance dose: starting with ./1miligrams per kilogram of body weight are injected in one minute up to a maximum dose of 2 Mg per kilogram of body weight per minute, which is continued for twenty-four hours in case of clinical response.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Fateme Kiani ara
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
71936-13311
Phone
+98 71 3647 4332
Fax
+98 71 3647 4326
Email
nemazee_inf@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad hashem Hashempoor
Street address
The central building of Shiraz University of Medical Sciences, Zand Street in front of Palestine Street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Kiani ara
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Namazi hospital , Namazi square
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
fateme81kiani71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali akbar Asadipooya
Position
Professor attending
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
aliasadipooya@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fteme Kiani ara
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 3647 4332
Email
fateme81kiani71@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