Comparison of the effect of intravenous and spinal dexmedetomidine on the quality of spinal anesthesia in patients with inguinal hernia
Design
A clinical trial without a parallel control group, do not blind, randomized
Settings and conduct
The study was conducted at Shahid Mohammadi Hospital in Bandar Abbas. After obtaining written consent from all patients and after entering the operating room and being placed on the intravenous line of surgery with Angiocut No. 18, non-dominant patients were embedded and after connecting standard monitoring including NIBP (non-invasive blood pressure cuff), pulse oximetry and ECG symptoms The basic vitality of all of them is measured and recorded. All patients receive a balance of 10 ml/kg of saline before performing the block.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient with ASA I, II undergo inguinal hernia surgery; Exclusion criteria: Spinal anesthesia contraindication; ٍensitivity to anesthetic; Patients with addiction or with a history of chronic drug abuse or analgesia; Patients with heart block or unstable cardiovascular status; Patients receiving steroids and agonists; Patients with liver, kidney problems, adrenal and neuromuscular disorders, and diabetic patients; Patients with blockage failure who require medication or induction of general anesthesia; Patients receiving agonist a2
Intervention groups
Patients are divided into two groups. Patients in group I receive dexmedetomidine with normal saline and patients in group II receive normal saline
Main outcome variables
The severity of the pain; maximal sensory block; Maximum level of motion block; block initiation rate up to T10; sensory block recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N23
Registration date:2019-10-28, 1398/08/06
Registration timing:registered_while_recruiting
Last update:2019-10-28, 1398/08/06
Update count:0
Registration date
2019-10-28, 1398/08/06
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-21, 1398/06/30
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of intravenous and spinal dexmedetomidine on the quality of spinal anesthesia in patients with inguinal hernia
Public title
Comparison of the effect of intravenous and spinal dexmedetomidine on the quality of spinal anesthesia in patients with inguinal hernia
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18 to 70 years old
Patient with ASA I, II undergo inguinal hernia surgery
Exclusion criteria:
Patients with ASA greater than or equal to III
spinal anesthesia contraindication (Coagulation problems, increased ICP, sepsis, infection)
Patients with potential sensitivity to anesthetic or dexmedetomidine
Patient with underlying neurological defect
Patients with addiction or with a history of chronic drug abuse or analgesia
Patients with heart block or unstable cardiovascular status
Patients receiving steroids and agonists
Patients with liver, kidney problems, adrenal and neuromuscular disorders, and diabetic patients
Patients with blockage failure who require medication or induction of general anesthesia.
Patients receiving agonist a2
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The sample was randomly divided into two groups. Each envelope containing one of the two labels A and B represented one of the intervention groups.
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
Ethics committee of Hormozgan University of Medical Sciences
Street address
Deputy of research and technology, the Supreme Prophet's Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Approval date
2017-11-13, 1396/08/22
Ethics committee reference number
IR.HUMS.REC.1396.37
Health conditions studied
1
Description of health condition studied
inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Severity of pain
Timepoint
After surgery
Method of measurement
According to VAS
2
Description
Maximum level of sensory block
Timepoint
During surgery every ten minutes
Method of measurement
Through the cold feeling of cotton alcohol
3
Description
block initiation rate up to T10
Timepoint
Once before surgery
Method of measurement
observation
4
Description
sensory block recovery
Timepoint
Once after surgery
Method of measurement
observation
5
Description
Maximum level of motion block
Timepoint
During surgery every ten minutes
Method of measurement
Computing
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: 1 µg / kg receive dexmedetomidine with normal saline in a total volume of 20 ml at the same time 10 minutes before the intravenous block.
Category
Treatment - Drugs
2
Description
Second intervention group: 20 ml of normal saline are pumped through the syringe of the pump for 10 minutes before the venous block
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mohammadi Hospital of Bandar Abbas
Full name of responsible person
Hashem Jarineshin
Street address
Boulevard of the Islamic Republic of Iran, Bandar Abbas, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 76 3334 7000
Email
Anrc.hums@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Abdul Azim Nejati Zadeh
Street address
Deputy of research and technology, East Side, Bandar Abbas Hospital, Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 71 3333 5794
Email
azimnejate @yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Iran University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 917 361 3464
Email
shmh@hums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 917 361 3464
Email
shmh@hums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hashem Jarineshin
Position
Associate Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Shahid Mohammadi Hospital
City
Bandar Abbas
Province
Hormozgan
Postal code
9791991551
Phone
+98 917 361 3464
Email
shmh@hums.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
No - There is not 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
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
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Shahid mohammadi hospital
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.