Comparison of the effect of thiopental sodium and propofol on cerebral coma in patients with traumatic brain injury
Design
This study will be a double-blind randomized clinical trial with parallel groups on 60 patients with traumatic brain injury referred to Peymaniyeh Hospital in Jahrom. Patients participating in the study will be divided into two groups by tossing coins.
Settings and conduct
Patients with traumatic brain injury referred to Peymaniyeh Hospital in Jahrom will be included in the study. Patients participating in the study will be divided into two groups of propofol and sodium thiopental by tossing coins. The person participating in the study, the researcher and the data collector will be unaware of the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with traumatic brain injury in Peymanieh Hospital in Jahrom city with the full consent of the patient and his legal parents to participate in the study
Exclusion criteria: Pregnant patients will not be allowed to enter the study.
Intervention groups
Intervention group 1: Patients in the thiopental group in the intensive care unit will receive 2 mg per kg body weight of sodium thiopental bolus injection and a maintenance dose of 2 to 6 mg per kg body weight per hour. Intervention group 2: Patients in the propofol group in the intensive care unit will receive a bolus injection of propofol 0.5 mg per kilogram of body weight, followed by an injection of propofol 3 to 5.4 per kilogram of body weight per hour.
Main outcome variables
Induction of coma
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050976N1
Registration date:2021-05-17, 1400/02/27
Registration timing:prospective
Last update:2021-05-17, 1400/02/27
Update count:0
Registration date
2021-05-17, 1400/02/27
Registrant information
Name
navid kalani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6085
Email address
k.navid@juma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-31, 1400/03/10
Expected recruitment end date
2021-10-02, 1400/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of coma induced by thiopental and propofol in Traumatic Brain Injury patients admitted in intensive care unit
Public title
Comparison of the effect of coma induced by thiopental and propofol in Traumatic Brain Injury patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Consciousness level less than 8 according to Glasgow Coma Scale (GCS)
Head injury without damage to other vital organs
Full consent of the patient and his / her legal guardians to participate in the study
Exclusion criteria:
pregnancy
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients participating in the present study will be divided into two groups: propofol and sodium thiopental by tossing coins.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, in the present study, the double-blind method is used so that the person reviewing the results and the person performing the injections do not know which patients received propofol and which
thiopental sodium. The syringes will be covered with black glue.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jahrom University of Medical Sciences
Street address
Jahrom, Shahid Motahari Boulevard, Jahrom University of Medical Sciences, Vice Chancellor for Research
City
jahrom
Province
Fars
Postal code
7167758256
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.JUMS.REC.1399.149
Health conditions studied
1
Description of health condition studied
Patients with traumatic brain injury
ICD-10 code
S06.1X7
ICD-10 code description
Traumatic cerebral edema with loss of consciousness of any duration with death due to brain injury prior to regaining consciousness
Primary outcomes
1
Description
Induction of coma
Timepoint
Before injection and then for three days (three times a day: morning, noon and night shifts)
Method of measurement
By bispectral index criteria
Secondary outcomes
1
Description
level of consciousness
Timepoint
Measure before injection and after injection daily (every 15 minutes) for 3 days
Method of measurement
Glasgow Criterion
2
Description
Vital signs
Timepoint
Measure before injection and after injection daily (every 15 minutes) for 3 days
Method of measurement
Monitoring device
Intervention groups
1
Description
Intervention group 1: Patients in group 1 will receive sodium thiopental drug in the intensive care unit as a bolus of 2 mg per kg of body weight and a maintenance dose of 2 to 6 mg per kg of body weight per hour.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients in group two will receive propofol in the intensive care unit as a bolus of 5 mg per kg of body weight and a maintenance dose of 3 to 4.5 mg / kg of body weight per hour.