Comparison post traumatic stress and awareness in traumatic lower limb surgery patients after neuraxial anesthesia with propofol and midazolam drugs
Design
A double blind, parallel, randomized clinical trial with a parallel group design of 220 patients. randomization was performed with a random sequence with SAS software
Settings and conduct
double blind randomized clinical trial in bahonar hospital of Kerman city, patients were randomly assigned to one of the groups of study, to receive propofol or midazolam sedation during neuroaxial anesthesia. main investigator and data analyzer were masked of patients allocation. patients did not know which drug prescribed and checklists did not contain any drug name. only the nurse know the name of medication.
Participants/Inclusion and exclusion criteria
age between 18-50 years old
trauma and were a candidate for lower extremity surgery,
Intervention groups
In propofol group, propofol infusion (at dose of 25-75 µg/kg/minute) was infused during surgery and in Midazolam group 1-2 mg of midazolam was injected PRN until patients reached a score of 3 according to Modified observers Assessment of Alertness/ sedation scale
Main outcome variables
stress level during neuraxial anesthesia in lower extremity surgery in trauma patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190819044559N3
Registration date:2020-06-13, 1399/03/24
Registration timing:retrospective
Last update:2020-06-13, 1399/03/24
Update count:0
Registration date
2020-06-13, 1399/03/24
Registrant information
Name
Morteza Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3223 5011
Email address
mortezahashemian@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-29, 1398/06/07
Expected recruitment end date
2020-02-26, 1398/12/07
Actual recruitment start date
2019-09-12, 1398/06/21
Actual recruitment end date
2020-03-14, 1398/12/24
Trial completion date
2020-04-02, 1399/01/14
Scientific title
Post traumatic stress and awareness in traumatic lower limb surgery patients after neuraxial anesthesia : A randomized clinical trial
Public title
Stress level after surgery in spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Trauma and candidate for lower extremity surgery
Age between 18-50 years
Exclusion criteria:
History of psychiatric disorders
Previous history of lower leg surgery
Refusal to attend the study
More than 3 hours of surgery duration
Severe blood loss
Decrease in consciousness and endotracheal intubation during surgery
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
220
Actual sample size reached:
220
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients randomly divided in two groups (110 patients in each group) using random allocation sequence with SAS statistical software. according to this method a simple randomization list product and patients`involvement in each group determine base on order entry. we used sequentially numbered, sealed opaque envelopes for allocation concealment. patients (individuals) were the randomization units.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, main investigator and data analyser were masked of patients allocation. patients did not know which drug prescribed and checklists did not contain any drug name. only the nurse know the name of medication.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Ebn-e-Sina St.,Jahad Blvd, Kernan,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2016-02-13, 1394/11/24
Ethics committee reference number
.kmu.REC.1394.508
Health conditions studied
1
Description of health condition studied
Post-traumatic stress
ICD-10 code
F43.11
ICD-10 code description
Post-traumatic stress disorder, acute
Primary outcomes
1
Description
ُُStress level after trauma according to Mississippi questionnaire
Timepoint
One day before surgery, after transfer to Recovery,1 and 7 days after surgery
Method of measurement
Mississippi questionnaire
2
Description
Awareness level after neuraxial anesthesia with midazolam or propofol
Timepoint
One day before surgery, after transfer to Recovery,1 and 7 days after surgery
Method of measurement
The Brace questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Propofol infusion of 25-75 micro grams per kilogram per minute is recommended
Category
Treatment - Drugs
2
Description
Control group: 1-2 mg of midazolam PRN is recommended
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid bahonar hospital
Full name of responsible person
Morteza Hashemian
Street address
Gharani street, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
3713747181
Phone
+98 34 3223 5015
Email
mortezahashemian@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Abbas Pardakhti
Street address
Ebn-e-Sina St.,Jahad Blvd, Vice chancellor for research
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Morteza Hashemian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gharani st. Shahid Bahonar hospital
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3223 5011
Fax
Email
mortezahashemian@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Morteza Hashemian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gharani st. Shahid Bahonar hospital
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3223 5011
Fax
Email
mortezahashemian@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Morteza Hashemian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Gharani st. Shahid Bahonar hospital
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3223 5011
Fax
Email
mortezahashemian@kmu.ac.ir
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