Comparison on analgesic and sedative effects of dexmedetomidine and midazolam in patients undergoing cesarean section
Design
Clinical trials with control group, with parallel groups, Blind two-sided, randomized, without control with placebo, single center trial.
Settings and conduct
The drug is injected with Dexmedetomidine or midazolam, or normal saline after the baby is removed and the umbilical cord clam.
Amir Al-Momenin Hospital.
The participant, the main researcher, health personnel who evaluate the outcomes will not be informed about the grouping of patients and the type of medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women 20 to 40 years; Women candidates for elective cesarean; Repeated cesarean (second to fourth).
Exclusion criteria: Preeclampsia patients; Chronic blood pressure; Emergency cesarean; Arrhythmia and heart block; Drug use: calcium blocker, adrenergic receptor blocker, psychoactive drugs.
Intervention groups
Intervention group 1: 0.5 mg / kg doses of dexmedetomidine in 100 ml of normal saline in 10 minutes.
Intervention group 2: Midazolam infusion 2 mg per 100 ml of normal saline within 10 minutes.
Control group: 100 cc normal saline infusion in 10 minutes.
Main outcome variables
Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N40
Registration date:2019-07-13, 1398/04/22
Registration timing:registered_while_recruiting
Last update:2019-07-13, 1398/04/22
Update count:0
Registration date
2019-07-13, 1398/04/22
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-21, 1397/05/30
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison on analgesic and sedative effects of dexmedetomidine and midazolam in patients undergoing cesarean section
Public title
Comparison on analgesic and sedative effects of dexmedetomidine and midazolam in patients undergoing cesarean section
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women 20 to 40 years
Women candidates for elective cesarean
Repeated cesarean (second to fourth)
Exclusion criteria:
Preeclampsia patients
Chronic blood pressure
Emergency cesarean
Arrhythmia and heart block
Drug use: calcium blocker, adrenergic receptor blocker, psychoactive drugs
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 3).
Using Excel software to generate random number tables.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, the main researcher, health personnel who evaluate the outcomes will not be informed about the grouping of patients and the type 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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2018-08-21, 1397/05/30
Ethics committee reference number
IR.SEMUMS.REC.1397.123
Health conditions studied
1
Description of health condition studied
Caesarean section
ICD-10 code
O84.2
ICD-10 code description
Multiple delivery, all by caesarean section
Primary outcomes
1
Description
Pain intensity
Timepoint
6 and 12 hours after surgery
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 0.5 mg / kg doses of dexmedetomidine in 100 ml of normal saline in 10 minutes
Category
Diagnosis
2
Description
Intervention group 2: Midazolam infusion 2 mg per 100 ml of normal saline within 10 minutes
Category
Diagnosis
3
Description
Control group: 100 cc normal saline infusion in 10 minutes
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Elham Saffarieh
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Elham Saffarieh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Saffarieh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atoosa Naviafar
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Amir Al-Momenin Hospital, Mostafa Khomeini Blvd
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
are20935@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Elham Saffarieh, Amir Al-Momenin Hospital, Mostafa Khomeini Blvd. +989123313982
What processes are involved for a request to access data/document