HypotensionNCT04673253
Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?
A study testing Passive leg Raise in people with Hypotension, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypotension
- What is being tested?
- Passive leg Raise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2020to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Parturients who are planned for the elective cesarean section
Who cannot join
- Failed spinal block
- Shift to general anesthesia
- Severe cardiac disease
- Hypertensive disorders of pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Antalya Training and Research Hospital
Antalya, 07100
About this study
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.
- Conditions
- Hypotension
- Being tested
- Passive leg Raise, control
- Keywords
- cesarean section, hypotension, spinal anesthesia, passive leg raise
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive leg RaiseOther
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.
controlOther
The controlled group was positioned in the normal supine position.
| Study group | Role | What they receive |
|---|---|---|
| Passive leg raise | Active comparator | group for passive leg raise Receives: Other: Passive leg Raise |
| Control | Placebo comparator | Not described Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Measured: Before the spinal anesthesia in the supine position
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Measured: 1 minute after the spinal anesthesia in the supine position
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Measured: 2 minutes after the spinal anesthesia in the supine position
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Measured: 3 minutes after the spinal anesthesia in the supine position
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Measured: 4 minutes after the spinal anesthesia in the supine position
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Measured: 5 minutes after the spinal anesthesia in the supine position
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Measured: 7 minutes after the spinal anesthesia in the supine position
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Measured: 9 minutes after the spinal anesthesia in the supine position
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Measured: 11 minutes after the spinal anesthesia in the supine position
Systolic blood pressure
Systolic blood pressure will be recorded from the monitor
Measured: 1 minute after the umblical cord clamping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start15 Nov 2020
- Primary completion31 Dec 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erhan Ozyurt, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673253
- Sponsor's protocol ID
- AntalyaEAH03
- Status last verified
- Feb 2021
- First submitted
- 13 Dec 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?
- ClinicalTrials.gov ID
- NCT04673253
- Acronym / sponsor ID
- AntalyaEAH03
- Conditions
- Hypotension
- Keywords
- cesarean section, hypotension, spinal anesthesia, passive leg raise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive leg raise | Active comparator | Other: Passive leg Raisegroup for passive leg raise |
| Control | Placebo comparator | Other: control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Parturients who are planned for the elective cesarean section
Key exclusion criteria (4 listed)
- Failed spinal block
- Shift to general anesthesia
- Severe cardiac disease
- Hypertensive disorders of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive leg RaiseThe 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. | Other | Passive leg raise |
| controlThe controlled group was positioned in the normal supine position. | Other | Control |
Primary outcome
Systolic blood pressure
Time frame: Before the spinal anesthesia in the supine position
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Time frame: 1 minute after the spinal anesthesia in the supine position
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Time frame: 2 minutes after the spinal anesthesia in the supine position
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Time frame: 3 minutes after the spinal anesthesia in the supine position
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Time frame: 4 minutes after the spinal anesthesia in the supine position
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Time frame: 5 minutes after the spinal anesthesia in the supine position
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Time frame: 7 minutes after the spinal anesthesia in the supine position
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Time frame: 9 minutes after the spinal anesthesia in the supine position
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Time frame: 11 minutes after the spinal anesthesia in the supine position
Systolic blood pressure will be recorded from the monitor
Systolic blood pressure
Time frame: 1 minute after the umblical cord clamping
Systolic blood pressure will be recorded from the monitor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive leg Raise in people with Hypotension, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: Before the spinal anesthesia in the supine position). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.