Comparison of the efficacy of adding dexmedetomidine and fentanyl in spinal anesthesia with bupivacaine in cesarean section.
Design
In the intervention group, intrathecal injection of 3 μg dexmedetomidine with 12.5 mg bupivacaine and in the control group intravenous injection of 25 μg fentanyl with 12.5 mg bupivacaine.
The sample size is 40 people in each group by simple random sampling and three blind sampling
Settings and conduct
This study was carried out on 80 pregnant women with II and ASA I candidates for elective elective cesarean section after confirmation of research consent from Mashhad University of Medical Sciences. In the intervention group, intrathecal injection of 3 μg dexmedetomidine with 12.5 mg bupivacaine and in the control group intravenous injection of 25 μg fentanyl with 12.5 mg bupivacaine.
The number of blinds is three blind and those who are blind are the study subjects, evaluators and analysts.
Participants/Inclusion and exclusion criteria
In clusion criteria: mothers of ASA I, II, 18 to 45 years of age and candidate for elective cesarean section. Exclusion criteria: history of medicinal allergy; history of cardiac block and dyserythia; use of drugs such as calcium-blocker adrenergic receptor antagonist-angiotensin inhibitors; gestational age less than 36 weeks; hypertension and preeclampsia; gestational diabetes; coagulopathy uterus; anesthesia site infection; high intracranial pressure and BMI greater than 35.
Intervention groups
In the intervention group, intrathecal injection of 3 μg dexmedetomidine with 12.5 mg bupivacaine is used.
In the control group, intrathecal injection of 25 micrograms of fentanyl plus 12.5 mg of bupivacaine is used.
Main outcome variables
Postoperative Pain Using NRS Scale; Time of First Dose of Postoperative Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191021045175N1
Registration date:2019-12-11, 1398/09/20
Registration timing:prospective
Last update:2019-12-11, 1398/09/20
Update count:0
Registration date
2019-12-11, 1398/09/20
Registrant information
Name
Seyed hosein Khademi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 2738
Email address
khademihs@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of Addition of Dexmedetomidine and Fentanyl in Spinal Anesthesia with Bupivacaine in Cesarean Section
Public title
The Effect of dexmedetomidine on pain control of post cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I, II
Age: 18 to 45 years old
Candidate for elective cesarean section
Exclusion criteria:
History of medicinal allergies
History of cardiac block and dysrythmia
Use of drugs such as calcium blocker-adrenergic receptor antagonist-angiotensin inhibitors
Gestational age less than 36 weeks
Hypertension and preeclampsia
Gestational diabetes
Coagulopathy
Intrauterine growth restriction
Anesthesia infection
High intracranial pressure
BMI greater than 35
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be enrolled in the study according to available sampling and then divided into two groups by simple random method via computer.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study subjects, evaluators and analyzor will be blinded for the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad Medical School
Street address
Shariati Square. University Ave. Imam Reza Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
1234567890
Approval date
2019-10-13, 1398/07/21
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.528
Health conditions studied
1
Description of health condition studied
Duration of analgesia after spinal anesthesia
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Duration of analgesia after spinal anesthesia
Timepoint
Postoperatively in recovery time up to 2 hours and then in every two hours up to 8 hours and then every 4 hours up to 24 hours after surgery
Method of measurement
Numerical Rating Scale (NRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, intrathecal injection of 3 μg dexmedetomidine with 12.5 mg bupivacaine was used.
Category
Treatment - Drugs
2
Description
In the control group, intrathecal injection of 25 micrograms of fentanyl plus 12.5 mg of bupivacaine is used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternity ward of Imam Reza hospital in Mashhad
Full name of responsible person
Seyed Hosein Khademi
Street address
Shariati Square. Imam Reza Hospital. Building 610. Office of Anesthesiology
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3502 9683
Email
khademihs@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
khorasan razavi - mashhad - university street - in front of university street 18 - Vice chancellor for research, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3841 2081
Fax
+98 51 3882 3251
Email
tafaghodim@mums.ac.ir
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, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Hosein Khademi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Daneshgah St.
City
mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3878
Email
khademihs@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed Hosein Khademi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3878
Email
khademihs@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
seyed hosein khademi
Position
assistance professore
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3858 3878
Fax
+98 51 3858 3878
Email
khademihs@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
DATA IS PRIVATE
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Comparison of the efficacy of adding dexmedetomidine and fentanyl in spinal anesthesia with bupivacaine in cesarean sectio
When the data will become available and for how long
20/09/2020
To whom data/document is available
ALL
Under which criteria data/document could be used
For method and results distribution
From where data/document is obtainable
Mashhad University of Medical Sciences
What processes are involved for a request to access data/document