The effect of Head elevation after spinal anesthesia on hemodynamic and sensory block height during elective cesarean delivery in pregnant women referred to Maryam Hospital
The effect of Head elevation after spinal anesthesia on hemodynamic and sensory block height during elective cesarean delivery
Design
A randomized clinical trial, two groups of 30; intervention: Spinal anesthesia by raising the patient's head 30 degrees and control Spinal anesthesia without raising the patient's head, randomized using the random numbers table.
Settings and conduct
Pregnant women candidates for elective cesarean section referred to Maryam Hospital with the conditions of entry into the study will be randomly placed in two groups of 30 in one of the intervention/control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with consent to participate in the project; Pregnant women with ASA Class I, II ; Gestation age 39-37 weeks; Singleton.
Exclusion criteria: Pregnant women with lack of consent to participate in the project; Diseases related to pregnancy such as gestational hypertension; preeclampsia; gestational diabetes; Multiple births; Known fetal anomaly; Local infection; History of drug abuse; People who are unable to maintain the position when the needle is inserted; History of spine surgery Presence of wound and infection at the needle entry site.
Intervention groups
Intervention group: For spinal anesthesia, a simple pillow is used for the patient and the patient's head is raised 30 degrees.
Control group: Spinal anesthesia is performed without raising the patient's head.
Main outcome variables
The height of the sensory block, Maternal hemodynamic
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211112053042N3
Registration date:2022-09-17, 1401/06/26
Registration timing:prospective
Last update:2022-09-17, 1401/06/26
Update count:0
Registration date
2022-09-17, 1401/06/26
Registrant information
Name
Mohammad Hossein Delshad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3350 2347
Email address
m.delshad@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-01, 1401/07/09
Expected recruitment end date
2023-01-19, 1401/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Head elevation after spinal anesthesia on hemodynamic and sensory block height during elective cesarean delivery in pregnant women referred to Maryam Hospital
Public title
The effect of raising the head after spinal anesthesia on blood pressure and level of anesthesia in elective cesarean delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women with consent to participate in the project
Pregnant women with ASA Class I, II
Gestation age 39-37 weeks
Singleton
Exclusion criteria:
Pregnant women with lack of consent to participate in the project
Diseases related to pregnancy such as gestational hypertension, preeclampsia, gestational diabetes
Multiple births
Known fetal anomaly
Local infection
History of drug abuse
People who are unable to maintain the position when the needle is inserted
History of spine surgery
Presence of wound and infection at the needle entry site
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Study subjects will be divided into two groups, control and intervention, using a simple randomization method and using a table of random numbers. First, each person is assigned a number. Then, using the table of random numbers, each selected number is randomly assigned to one of the groups, and this work continues until the number of people in each group is completed. Therefore, the researcher will not have the authority to change the status of the assignment of people or to predict it. Randomization concealment will be done by a third person who does not participate in other stages of the intervention.
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 Alborz University of Medical Sciences
Street address
second floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr, Karaj.
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-06-24, 1401/04/03
Ethics committee reference number
IR.ABZUMS.REC.1401.082
Health conditions studied
1
Description of health condition studied
Spinal anesthesia
ICD-10 code
O89. 4
ICD-10 code description
Spinal and epidural anesthesia
Primary outcomes
1
Description
The height of the sensory block
Timepoint
Every 5 minutes from the time of spinal injection until the embryo is removed and the end of the surgery
Method of measurement
By pinprick test
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
Every minute from the time of spinal injection until the fetus is removed and then every 5 minutes
Method of measurement
Measurement with pressure gauge
2
Description
Diastolic blood pressure
Timepoint
Every minute from the time of spinal injection until the fetus is removed and then every 5 minutes
Method of measurement
Measurement with pressure gauge
3
Description
Heart rate
Timepoint
Every minute from the time of spinal injection until the fetus is removed and then every 5 minutes
Method of measurement
Measurement with non-invasive devices
4
Description
Oxygen saturation
Timepoint
Every minute from the time of spinal injection until the fetus is removed and then every 5 minutes
Method of measurement
Pulse Oximetry
5
Description
Maternal complications
Timepoint
Every minute from the time of spinal injection until the fetus is removed
Method of measurement
Doctor's diagnosis
6
Description
Apgar score
Timepoint
At 1 and 5 minutes after birth
Method of measurement
Neonatal specialist examination
Intervention groups
1
Description
Intervention group: Spinal anesthesia is performed in the sitting position from the L2-L3 or L3-L4 spaces with the Midline approach using a Quincke needle 25 gage and 8-12 ml of 0.1% ropivacaine. The patient's head is elevated 30 degrees with a simple pillow.
Category
Prevention
2
Description
Control group: Spinal anesthesia is performed like the intervention group without elevating the patient's head.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Maryam Hospital
Full name of responsible person
Mohammad Hossein Delshad MD.
Street address
Arghvan West, 45 meter Golshahr St.
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 9323
Email
m.delshad@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Hatam Godini P.H.D
Street address
Saffarian alley, 45 meters from Golshahr, Karaj
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
h.godini@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Hossein Delshad MD.
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
City
Karaj
Province
Alborz
Postal code
3198683639
Phone
+98 26 3350 2347
Email
m.delshad@abzums.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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published.
To whom data/document is available
Research centers and faculty members
Under which criteria data/document could be used
At the request of the researcher and faculty members
From where data/document is obtainable
Send email to the scientific respondent
What processes are involved for a request to access data/document
Within two months from the time of requesting and sending the email, the documents will be sent to the mentioned people