Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?
Primary Purpose
Hypotension
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Passive leg Raise
control
Sponsored by
About this trial
This is an interventional prevention trial for Hypotension focused on measuring cesarean section, hypotension, spinal anesthesia, passive leg raise
Eligibility Criteria
Inclusion Criteria:
- Parturients who are planned for the elective cesarean section
Exclusion Criteria:
- Failed spinal block
- Shift to general anesthesia
- Severe cardiac disease
- Hypertensive disorders of pregnancy
Sites / Locations
- University of Health Sciences, Antalya Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Passive leg raise
Control
Arm Description
group for passive leg raise
Outcomes
Primary Outcome Measures
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Secondary Outcome Measures
Full Information
NCT ID
NCT04673253
First Posted
December 13, 2020
Last Updated
February 15, 2021
Sponsor
Antalya Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04673253
Brief Title
Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?
Official Title
Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Antalya Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
All over the world, spinal anesthesia is widely used in cesarean sections due to its superiority over general anesthesia. Due to reasons such as increased sensitivity to local anesthetics and increased intra-abdominal pressure in pregnant women, the frequency of hypotension increases by up to 70%. As a result of the blockage of sympathetic vasoconstrictor fibers originating from T1-L2 segments, loss of peripheral resistance, venous ponding occurs, and cardiac output decreases. Also, the level required for cesarean operation is T4 or T5, and the possibility of affecting the cardiac accelerator fibers, so bradycardia due to the increase in parasympathetic activity may deepen the hypotension. If postspinal hypotension is not managed correctly, it may lead to maternal and fetal complications. In addition to classical methods such as fluid loading and prophylactic vasoconstrictor application to prevent hypotension in pregnant women after spinal anesthesia, techniques such as wrapping the lower extremity, lifting, or applying both together have been in question.
Passive leg raise application is an easy method that allows the blood collected in the lower part of the body to participate in the central circulation with the effect of gravity. An increase in venous return occurs with the passage of blood from the lower extremities to the thorax. Thus, it leads to an increase in stroke volume and an increase in cardiac output. In this study, we aimed to determine the effectiveness of passive leg raising in preventing or reducing the depth of hypotension after spinal anesthesia in pregnant women who underwent cesarean section under spinal anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
cesarean section, hypotension, spinal anesthesia, passive leg raise
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Passive leg raise
Arm Type
Active Comparator
Arm Description
group for passive leg raise
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Passive leg Raise
Intervention Description
The intervention will be performed immediately after spinal anesthesia, and passive leg raise will be performed using two standard pillows placed under the heel so that the leg is approximately 30 cm above the horizontal plane of the table. The passive leg raising position will continue until the cord is clamped.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
The controlled group was positioned in the normal supine position.
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Systolic blood pressure will be recorded from the monitor
Time Frame
Before the spinal anesthesia in the supine position
Title
Systolic blood pressure
Description
Systolic blood pressure will be recorded from the monitor
Time Frame
1 minute after the spinal anesthesia in the supine position
Title
Systolic blood pressure
Description
Systolic blood pressure will be recorded from the monitor
Time Frame
2 minutes after the spinal anesthesia in the supine position
Title
Systolic blood pressure
Description
Systolic blood pressure will be recorded from the monitor
Time Frame
3 minutes after the spinal anesthesia in the supine position
Title
Systolic blood pressure
Description
Systolic blood pressure will be recorded from the monitor
Time Frame
4 minutes after the spinal anesthesia in the supine position
Title
Systolic blood pressure
Description
Systolic blood pressure will be recorded from the monitor
Time Frame
5 minutes after the spinal anesthesia in the supine position
Title
Systolic blood pressure
Description
Systolic blood pressure will be recorded from the monitor
Time Frame
7 minutes after the spinal anesthesia in the supine position
Title
Systolic blood pressure
Description
Systolic blood pressure will be recorded from the monitor
Time Frame
9 minutes after the spinal anesthesia in the supine position
Title
Systolic blood pressure
Description
Systolic blood pressure will be recorded from the monitor
Time Frame
11 minutes after the spinal anesthesia in the supine position
Title
Systolic blood pressure
Description
Systolic blood pressure will be recorded from the monitor
Time Frame
1 minute after the umblical cord clamping
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parturients who are planned for the elective cesarean section
Exclusion Criteria:
Failed spinal block
Shift to general anesthesia
Severe cardiac disease
Hypertensive disorders of pregnancy
Facility Information:
Facility Name
University of Health Sciences, Antalya Training and Research Hospital
City
Antalya
ZIP/Postal Code
07100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?
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