Comparison of the effect of zolpidem and amantadine on the level of consciousness in patients with diffuse axonal injury: a randomized clinical trial study
Design
A randomized controlled clinical trial with parallel groups, randomized, using Random allocation software
Settings and conduct
This study was performed on 66 patients with vegetable status approved by a neurosurgeon, as well as written consent from their fellows, who were randomly divided into 3 groups. The first group received 10 mg of Zolpidem daily for 8 days in the first group and the second group received 100 mg of amantadine capsule daily for 8 days. The third is given placebo daily for 8 days and during these 8 days up to 3 days after discontinuation of the medication the patients' consciousness status is monitored daily through Glasgow grade is evaluated and then all three groups are compared. Assistant Neurosurgery Assistant Knows No Patient Grouping
Participants/Inclusion and exclusion criteria
1. Confirmation of axonal injury published by a specialist in neurosurgery.
2. GCS less than or equal to 8
3. Age between 15 and 70 years
4. Hospitalized less than 8 hours after injury
5. Informed consent from the patient's companions for inclusion in the study
Exit
1. Patient's or guardian's dissatisfaction with the study
2. A history of drug allergy to zolpidem or amantadine
3. History of any previous brain trauma
4. History of any previous brain procedure
Intervention groups
The first group is given 8 mg of Zolpidem Tablets daily for 8 days and the second group is given 100 mg Amantadine capsule daily for 8 days.
Main outcome variables
Increased level of consciousness in patients with diffuse axonal injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191026045243N1
Registration date:2019-11-26, 1398/09/05
Registration timing:prospective
Last update:2019-11-26, 1398/09/05
Update count:0
Registration date
2019-11-26, 1398/09/05
Registrant information
Name
Sajad Shafiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1630
Email address
sajad.shafiee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of zolpidem and amantadine on the level of consciousness in patients diffuse axonal injury
Public title
The effect of zolpidem and amantadine on the level of consciousness in patients diffuse axonal injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Confirmation of axonal injury published by a specialist in neurosurgery
2. GCS less than or equal to 8
3. Age between 15 and 70 years
4. Hospitalized less than 8 hours after injury
5. Informed consent from the patient's companions for inclusion in the study
Exclusion criteria:
1. Patient's or guardian's dissatisfaction with the study
2. A history of drug allergy to zolpidem or amantadine
3. History of any previous brain trauma
4. History of any previous brain procedure
Age
From 15 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Initially, 66 patients with inclusion criteria will be selected by available sampling method and then these samples will be divided into 3 groups using blocking method. The block allocation process will be done using Random allocation software. The block size will also be random.
Blinding (investigator's opinion)
Single blinded
Blinding description
The first group received Zolpidem 10 mg daily for 8 days, the second group received 100 mg Amantadine capsule daily for 8 days, and the third group received 8 mg daily. Daily, placebo is given daily and during these 8 days and up to 3 days after discontinuation of the medication, patients' consciousness status is assessed daily by the Glasgow Critical Assistant, Neurosurgery Assistant.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital of Sari - Mazandaran University of Medical Sciences
Street address
Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
48166-33131
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.119
Health conditions studied
1
Description of health condition studied
diffuse axonal injury
ICD-10 code
G35-G37
ICD-10 code description
بیماریهای از بین برنده میلین در سیستم عصبی مرکزی
Primary outcomes
1
Description
Increased awareness and speed of recovery for patients with cognitive problems and brain injuries
Timepoint
During these 8 days and up to 3 days after discontinuation of the drug
Method of measurement
Glasgow Coma Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group received 10 mg of Zolpidem daily for 8 days and the second group received 100 mg of amantadine capsule daily for 8 days.
Category
Treatment - Drugs
2
Description
Control group: The third group received placebo daily for 8 days