This study will be done with aim to Comparative study on the effect of adding Dexmedetomidine than intrathecal Marcaine than Sufentanil in
elective cesarean surgery in Imam Reza Hospital in Kermanshah city. This study is one blinded clinical trial. The research population includes all patients undergoing cesarean surgery. 60 eligible patients will be selected in an available method and randomly assigned to two intervention groups. First, each group receives 500 cc of Ringer Infusion Syringe.
Then the first intervention group will receive 5 mg / d of Dexmedetomidine and 10 mg of Hyperbaric marcaine 0/5%. The second intervention group will receive 5mg of sufentanil with 10mg of hyperbaric marcaine 0/5%. After the surgery, the pain and duration of analgesia and headaches are measured by means of the VAS tool and recorded in the checklist, and the two groups are compared with each other. Inclusion criteria: singleton, 18 to 45 years term pregnant women with a body mass of 18 to 30 with ASA class 1 candidate for cesarean section
Exclusion criteria: Having any underlying disease such as cardiovascular disease (IHD cardiomyopathy), pre-eclampsia, Hypertension; neurological diseases such as migraine; Psychiatric diseases; History of allergy to local anesthesia; Emergency cesarean surgery; Cases requiring general anesthesia during surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101814333N82
Registration date:2017-10-25, 1396/08/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-25, 1396/08/03
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2017-12-31, 1396/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the effect and non effect of adding Dexmedetomidine than intrathecal Marcaine than Sufentanil in elective cesarean surgery
Public title
Comparative study on the effect of adding Dexmedetomidine than intrathecal Marcaine than Sufentanil in elective cesarean surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: singleton, 18 to 45 years term pregnant women with a body mass of 18 to 30 with ASA class 1 candidate for cesarean section
Exclusion criteria: Having any underlying disease such as cardiovascular disease (IHD cardiomyopathy), pre-eclampsia, Hypertension; neurological diseases such as migraine; Psychiatric diseases; History of allergy to local anesthesia; Emergency cesarean surgery; Cases requiring general anesthesia during surgery.
Age
From 18 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly by tossing coin
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
kums.rec.1395.257
Health conditions studied
1
Description of health condition studied
wound cesarean
ICD-10 code
034
ICD-10 code description
Maternal care due to uterine scar from previous surgery
Primary outcomes
1
Description
Painless
Timepoint
At the time of 1, 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours after the end of surgery
Method of measurement
Question from patient and visual observation (VAS)
2
Description
Headache
Timepoint
At the time of 1, 2, 4, 6, 8, 10, 12, 16, 20 and 24 hours after the end of surgery
Method of measurement
Question from patient and visual observation (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 5 mg / d of Dexmedetomidine and 10 mg of Hyperbaric marcaine 0.5%.
Category
Treatment - Drugs
2
Description
The second intervention group will receive 5mg of sufentanil with 10mg of hyperbaric marcaine 0.5%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mahrokh Alikhani
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahrokh Alikhani
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
parvizi.abfa@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Javad Amini Saman
Position
Anesthesiologist
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
Aminisaman399@Gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahrokh Alikhani
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Emam Reza Hospital, Parastar Blvd
City
Kermanshah
Postal code
Phone
+98 83 3427 6301
Fax
Email
parvizi.abfa@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)