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Comparison the effect of interathecal injection of Dexmedetomidine plus Bupivacanie and Bupivacanie on maternal hemodynamic parameters and pain; and neonatal APGAR and arterial blood gases of women undergoing cesarean delivery under spinal anesthesia

Protocol summary

Study aim
Comparison the effect of interathecal injection of Dexmedetomidine plus Bupivacanie and Bupivacanie on maternal hemodynamic parameters and pain; and neonatal APGAR and arterial blood gases of women undergoing cesarean delivery under spinal anesthesia
Design
Parallel double blinded randomized controlled clinical trial
Settings and conduct
Selecting 82 pregnant women candidate for elective cesarean delivery under spinal anesthesia at 5 Azar tertiary hospital affiliated to Golestan university of medical sciences and assigning them to two groups by block balanced randomization.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Pregnant women with repeated cesarean delivery, and more than 39 gestational age; Age between 18 to 40 years old; Candidate for elective cesarean delivery underwent spinal anesthesia; American Society of Anesthesiologists (ASA) physical status classification system I and II; Without history of respiratory, cardiovascular and systemic diseases, and cancers; Without history of drug abuse or sedative & hypnotic drugs; Without congenital malformation, and preterm labor; Without history of medication allergy; Without coagulopathy; Hemoglobin level above 10 g/dl. Exclusion Criteria: Use of sedative and hypnotic drugs before surgery; Use of anticoagulants 48 hours before surgery; With psychiatric disorders
Intervention groups
Intervention group: Intrathecal injection of 2.5 ml of Bupivacanie 0.5% plus 5 μg of Dexmedetomidine (total volume of 3.0 ml(. Control group: Intrathecal injection of 2.5 ml of Bupivacanie 0.5% with half a milliliter of 0.9 % saline (total volume of 3.0 ml)
Main outcome variables
Maternal hemodynamic parameters and pain; neonatal APGAR and arterial blood gases

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181107041590N1
Registration date: 2019-01-05, 1397/10/15
Registration timing: prospective

Last update: 2019-01-05, 1397/10/15
Update count: 0
Registration date
2019-01-05, 1397/10/15
Registrant information
Name
Monireh Jahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3232 0370
Email address
jahani.mn@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-10, 1397/10/20
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of interathecal injection of Dexmedetomidine plus Bupivacanie and Bupivacanie on maternal hemodynamic parameters and pain; and neonatal APGAR and arterial blood gases of women undergoing cesarean delivery under spinal anesthesia
Public title
Comparison the effect of Dexmedetomidine plus Bupivacanie and Bupivacanie on maternal hemodynamic parameters and pain; and neonatal APGAR and arterial blood gases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with repeated cesarean delivery and more than 39 gestational age Age between 18 to 40 years old Candidate for elective cesarean delivery underwent spinal anesthesia American Society of Anesthesiologists (ASA) physical status classification system I and II Without history of asthma, cardiovascular diseases, diabetes, acute and chronic renal failure, deep vein thrombosis, pulmonary embolism, peripheral vascular diseases, preeclampsia, eclampsia, seizure, convulsion, and cancers Without history of drug abuse or sedative & hypnotic drugs Without congenital malformation Without history of airway problems and systemic diseases, and preterm labor Without history of medication allergy Without coagulopathy Hemoglobin level above 10 g/dl Normal level of clotting time (CT), bleeding time (BT), prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR) Having at least two clinical visit with obstetrician and one blood test and 2 control sonography during pregnancy in pregnancy record Filling the informed consent form
Exclusion criteria:
Use of sedative and hypnotic drugs before surgery Use of anticoagulants 48 hours before surgery With psychiatric disorders
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Block balanced randomization method will be used. Randomization sequence will be generated by free website available from: www.randomization.com, in which letter A and B will be considered for intervention and control group, respectively. For random allocation concealment, cards containing blocks will be inserted in standard envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double blind study, patient and pain assessor are not aware of allocated groups. Main investigator is not aware of the pain pump content.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Hirkan Blvd., Beginning of Shastkola road, Falsafi Educational Campus of Golestan University of Medical Sciences, Gorgan town
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2018-11-18, 1397/08/27
Ethics committee reference number
IR.GOUMS.REC.1397.181

Health conditions studied

1

Description of health condition studied
Cesarean delivery
ICD-10 code
O75.82
ICD-10 code description
Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section

Primary outcomes

1

Description
Hemodynamic parameters (heart rate and blood pressure)
Timepoint
Before and 1, 5,15, 30 and 60 minute after surgery
Method of measurement
Vital-signs monitoring device

Secondary outcomes

1

Description
Maternal pain
Timepoint
Before and 1, 6, 12 and 24 hours after surgery
Method of measurement
Visual analogous scale

2

Description
Neonatal APGAR
Timepoint
1st and 5th minute after birth
Method of measurement
APGAR scale

3

Description
Arterial blood gases
Timepoint
After birth
Method of measurement
Arterial blood gases analysis

Intervention groups

1

Description
Intervention group: Intrathecal injection of 2.5 ml of Bupivacanie 0.5% (Astra Zeneca company, Sweden) plus 5 μg of Dexmedetomidine (Pfizer company, US) (total volume of 3.0 ml)
Category
Treatment - Drugs

2

Description
Control group: Intrathecal injection of 2.5 ml of Bupivacanie 0.5% (Astra Zeneca company, Sweden) with half a milliliter of 0.9 % saline (Shahid Ghazi pharmaceutical company) (total volume of 3.0 ml)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
5 Azar tertiary hospital
Full name of responsible person
Monireh Jahani
Street address
5th Azar street, 5 Azar tertiary hospital, Gorgan town
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3232 0370
Email
jahani.mn@goums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Honarvar
Street address
Hirkan Blvd., Beginning of Shastkola road, Falsafi Educational Campus of Golestan University of Medical Sciences, Gorgan town
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
honarvar@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Monireh Jahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
5th Azar street, 5 Azar tertiary hospital, Gorgan town
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3232 0370
Email
jahani.mn@goums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Ali Jabbari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
5th Azar street, 5 Azar tertiary hospital, Gorgan town
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3232 0370
Email
Amir_a_72@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Monireh Jahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
5th Azar street, 5 Azar tertiary hospital, Gorgan town
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3232 0370
Email
jahani.mn@goums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is 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
After making data unrecognizable, all data will be shared.
When the data will become available and for how long
Starting in January 2020
To whom data/document is available
It will be available for researchers working in academic institutions.
Under which criteria data/document could be used
For people who have academic education and those data can be useful for their research
From where data/document is obtainable
Dr. Ali Jabbari: Amir_a_72@yahoo.com
What processes are involved for a request to access data/document
Email to "Amir_a_72@yahoo.com" and comment that why he/she wants to access to these data
Comments
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