Comparison of the hemodynamic effects of the patient position (sitting, right and left lateral position) during induction of spinal anesthesia for caesarean section: a randomized clinical trial
To assess the hemodynamic effects of the patient position (sitting, right and left lateral position) during induction of spinal anesthesia for caesarean section
Design
This is a randomized clinical trial, in which eligible patients will be randomly assigned through the block randomization to the intervention groups.
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on 105 pregnant women candidate for cesarean section. The patients will be randomly assigned through the block randomization to the intervention groups. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 40 years;
Pregnant women candidate for cesarean section;
Exclusion criteria:
Multipara;
Cardiovascular disease or diabetes or preeclampsia;
Coagulopathy
Intervention groups
Intervention group 1:
Spinal anesthesia for cesarean section in a sitting position with spinal injection of 10 mg bupivacaine hyperbaric 5% plus 2.5 μg sufentanil
Intervention group 2:
Spinal anesthesia for cesarean section lying down on the right side with spinal injection of 10 mg bupivacaine hyperbaric 5% plus 2.5 micrograms sufentanil
Intervention group 3:
Spinal anesthesia for cesarean section lying down on the left side with spinal injection of 10 mg bupivacaine hyperbaric 5% plus 2.5 μg sufentanil
Main outcome variables
Primary outcome:
Blood pressure, heart rate
Secondary outcome
Side effects (nausea, vomiting and chilling), neonatal Apgar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N412
Registration date:2021-12-11, 1400/09/20
Registration timing:prospective
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the hemodynamic effects of the patient position (sitting, right and left lateral position) during induction of spinal anesthesia for caesarean section: a randomized clinical trial
Public title
Comparison of the hemodynamic effects of the patient position (sitting, right and left lateral position) during induction of spinal anesthesia for caesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years;
Pregnant women candidate for cesarean section;
Exclusion criteria:
Multipara;
Cardiovascular disease or diabetes or preeclampsia;
Coagulopathy
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the intervention 3. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.UMSHA.REC.1398.871
Health conditions studied
1
Description of health condition studied
Cesarean section
ICD-10 code
Z38.01
ICD-10 code description
Single liveborn infant, delivered by cesarean
Primary outcomes
1
Description
Blood pressure
Timepoint
ََAt 1, 2, 3, 4, 5, 10, 15 and 20 minutes after spinal anesthesia
Method of measurement
With a monitor
2
Description
Heart rate
Timepoint
ََAt 1, 2, 3, 4, 5, 10, 15 and 20 minutes after spinal anesthesia
Method of measurement
With a monitor
Secondary outcomes
1
Description
Side effects (nausea, vomiting and chilling)
Timepoint
20 minutes after spinal anesthesia
Method of measurement
With history taking
2
Description
Neonatal Apgar score
Timepoint
At 1 and 5 minutes after cesarean section
Method of measurement
With clinical examination
Intervention groups
1
Description
Intervention group 1: Spinal anesthesia for cesarean section in a sitting position with spinal injection of 10 mg bupivacaine hyperbaric 5% plus 2.5 μg sufentanil
Category
Treatment - Other
2
Description
Intervention group 2: Spinal anesthesia for cesarean section lying down on the right side with spinal injection of 10 mg bupivacaine hyperbaric 5% plus 2.5 micrograms sufentanil
Category
Treatment - Other
3
Description
Intervention group 3: Spinal anesthesia for cesarean section lying down on the left side with spinal injection of 10 mg bupivacaine hyperbaric 5% plus 2.5 μg sufentanil
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Mitra Garousi
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
mgarousi1375@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mitra Garousi
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mgarousi1375@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Maryam Davoudi
Position
Anesthesiologist
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mdavoudi10@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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