Effect of Pre-loading of Colloid-Crystaloid Combination on Maternal Hemodynamic Status Following Spinal Anesthesia for Cesarean Delivery
Design
Clinical trial with community-based and pragmatic control group, with parallel groups, blind, randomized,
Settings and conduct
70 pregnant women aged18-40 years,with single term pregnancy candidate for cesarean section with spinal anesthesia are studying .The patients are randomly assigned to receive intravenous fluid in 2 study group: the study group colloid + crystalloid solution (ringer) with equal volume and The placebo group received only crystalloids . After spinal anesthesia, the ringer solution was infused at 20 ml / kg / h until the end of the operation, and in each episode of hypotension, ml100 An extra ringer solution is prescribed.
Hemodynamic bases are recorded every 2 minutes until delivery and then every 5 minutes until the end of the operation.. The total dosage of vasopressors is recorded. Side effects caused by hypotension including nausea and vomiting, restlessness, decreased consciousness and respiratory depression are recorded and treated.The Apgar score is recorded in minutes 1 and 5 of the birth.
Participants/Inclusion and exclusion criteria
inclusion criteria :
- The desire to participate in the study
- Elective cesarean candidate
- A candidate for spinal anesthesia
- ages 18-40
- Class I ASA grading
- Single term pregnancy
Non-inclusion criteria:
- multifetal pregnancy
- Weight over 100 kg and height less than 150 cm
- History of systemic diseases
- History of mental disorders
- Contraindications for spinal anesthesia
- fetal problems
- Hypertension during pregnancy
Intervention groups
Intervention:colloid and crystalloid(ringer), 8ml/kg with equal volume
Placebo: crystalloid(Ringer) 8ml/kg
Effect of Pre-loading of Colloid-Crystaloid Combination on Maternal Hemodynamic Status Following Spinal Anesthesia for Cesarean Delivery
Public title
Effect of Pre-loading of Colloid-Crystaloid Combination on Maternal Hemodynamic Status Following Spinal Anesthesia for Cesarean Delivery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study
Elective cesarean candidate
A candidate for spinal anesthesia
ages 18-40
Class I ASA grading
Single term pregnancy
Exclusion criteria:
- multiple pregnancy
- Weight over 100 kg and height less than 150 cm
History of systemic diseases (cardiovascular, liver, kidney, etc.)-
History of mental disorder
Contraindications for spinal anesthesia
A history of allergy to Boyoukain
Emergency cesarean section
fetal problems(IUGR, meconium excretion, asyphexy ...)
Hypertension during pregnancy
Starch allergy
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After approving the Ethics Committee of the Vice-Chancellor for Research and Technology of Tabriz University of Medical Sciences and obtaining informed written consent from patients, 70 healthy women with term and singleton pregnancy who are candidates for elective cesarean section with spinal anesthesia were selected by simple sequential sampling ( consecutive ) Were randomly assigned to two groups according to the order of their choice and using randomized software (Rand list online).
Blinding (investigator's opinion)
Double blinded
Blinding description
Anesthesiologist has the responsibility of anesthesiology, patient monitoring and preparation of study solutions, and the thesis student who is unaware of the study group.
is responsible for collecting information and variables of patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Al Zahra hospital, Artesh Jonoubi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
513765716
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.TBZMED.REC.1398.120
Health conditions studied
1
Description of health condition studied
Effect of Pre-loading of Colloid-Crystaloid Combination on Maternal Hemodynamic Status Following Spinal Anesthesia for Cesarean Delivery
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery
Primary outcomes
1
Description
severity of hypotension
Timepoint
Basic times, every two minutes to 10 minutes, then minutes 15, 20, 30. 45 and 60 and the end
Method of measurement
Automatic pressure gauge
Secondary outcomes
1
Description
severity of Changes in Mother's Heart Rate
Timepoint
Basic times, every two minutes to 10 minutes, then minutes 15, 20, 30. 45 and 60 and the end
Method of measurement
pulseoximetry
Intervention groups
1
Description
Intervention group: The study group (35 cases (8ml / kg colloid + crystalloid solution (ringer) with equal volume
Category
Prevention
2
Description
Control group: The placebo group (35 cases) received only crystalloids at 8ml / kg in 15 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital, Operation Room and postoperative setting
Full name of responsible person
Dr. Simin Atashkhoei
Street address
Al Zahra hospital, Artesh Jonoubi Ave, Operating room, Dr. Simin Atashkhoyi
City
Tabriz
Province
East Azarbaijan
Postal code
5137657166
Phone
+98 41 3553 9161
Email
satashkhoyi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Abolghasem Jouyban
Street address
Tabriz University, Daneshgah Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
513765716
Phone
+98 41 3335 7310
Email
ajouyban@hotmail.com
Web page address
https://researchvice.tbzmed.ac.ir/PChart/94/1/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Professor, Specialist in Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Al Zahra hospital, Artesh Jonoubi Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5137657166
Phone
+98 41 3553 9161
Email
satashkhoyi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Simin Atashkhoei
Position
Professor, Specialist in Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology department, faculty of medicine, Tabriz Medical University
City
Tabriz
Province
East Azarbaijan
Postal code
5137657166
Phone
+98 41 3333 3806
Fax
+98 41 3556 6449
Email
atashkhoii@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Professor, Specialist in Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Alzahra Hospital, Artesh Jonoubi Ave, Tabriz Tabriz East Azerbaijan Iran, Islamic Republic Of
City
tabriz
Province
East Azarbaijan
Postal code
5137657166
Phone
+98 41 3553 9161
Email
satashkhoyi@gmail.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available