Spinal HypotensionNCT06822699
The Influence of Leg Elevation on Noradrenaline Requirements During Cesarean Delivery
A study testing Leg elevation in people with Spinal Hypotension and Hypoperfusion, run by Cairo University at 1 site in Egypt.
Trial summary
Spinal anesthesia is a widely chosen technique in obstetric theaters due to several advantages, however sympathetic block results in hypotension that carry several consequences on maternal and fetal health, thus early prediction and management takes high priority. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Spinal Hypotension, Hypoperfusion
- What is being tested?
- Leg elevation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Mar 2025to 8 May 2025
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- full term
- singleton pregnancy
- ASA II
Who cannot join
- decline to participate
- baseline SBP <100 mmHg
- failed spinal anesthesia
- allergy to local anesthetic
- coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Thirty-degree Leg Elevation on Noradrenaline Requirements Administered as a Prophylactic Variable Infusion During Cesarean Delivery: An Open Label Randomized Controlled Trial
Spinal anesthesia is a widely chosen technique in obstetric theaters due to several advantages, however sympathetic block results in hypotension that carry several consequences on maternal and fetal health, thus early prediction and management takes high priority. in this regards recent recommendations suggest the use of prophylactic vasopressors like noradrenaline, researchers of this study aimed to explore the impact of leg elevation on prophylactic noradrenaline dose
Read the detailed description
after spinal anesthesia, patients will be randomly allocated into 2 groups : Leg elevation group and control group.
noradrenaline will be used as variable infusion starting from 0.05 microgram/kg/min up to 0.14 microgram /kg/minute.
noradrenaline infusion will be continued till delivery of the baby
- Conditions
- Spinal Hypotension, Hypoperfusion
- Being tested
- Leg elevation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg elevationDevice
leg will be raised 30 degrees after spinal anesthesia using standardized pillow
| Study group | Role | What they receive |
|---|---|---|
| Leg elevation group | Experimental | leg will be elevated 30 degrees immediately after spinal anesthesia Receives: Device: Leg elevation |
| Control group | No intervention | Legs will remain supine after spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average noradrenaline requirements
average noradrenaline requirements in both groups (mcg/kg/min)
Measured: baseline to delivery of the baby
Secondary outcomes (3)
Total noradrenaline requirements
Measured: baseline to delivery
incidence of spinal hypotension
Measured: baseline to delivery
incidence of severe hypotension
Measured: baseline to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start14 Mar 2025
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal HypotensionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Adolf Helmy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822699
- Sponsor's protocol ID
- leg elevation and noradrenalin
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be available from corresponding author upon reasonable request
Publications
Hasanin A, Aiyad A, Elsakka A, Kamel A, Fouad R, Osman M, Mokhtar A, Refaat S, Hassabelnaby Y. Leg elevation decreases the incidence of post-spinal hypotension in cesarean section: a randomized controlled trial. BMC Anesthesiol. 2017 Apr 24;17(1):60. doi: 10.1186/s12871-017-0349-8.
PubMed 28438121Lyu W, Zhang Z, Li C, Wei P, Feng H, Zhou H, Zheng Q, Zhou J, Li J. Intravenous initial bolus during prophylactic norepinephrine infusion to prevent spinal hypotension for cesarean delivery: A randomized controlled, dose-finding trial. J Clin Anesth. 2024 Oct;97:111562. doi: 10.1016/j.jclinane.2024.111562. Epub 2024 Jul 23.
PubMed 39047530Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.
PubMed 30335625Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
PubMed 29090733Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.
PubMed 34034957Helmy MA, Naguib NN, Helmy KA, Milad LM. The influence of thirty-degree leg elevation on noradrenaline requirements administered as a prophylactic variable infusion during cesarean delivery, an open-label randomized controlled trial. J Anesth Analg Crit Care. 2025 Oct 28;5(1):73. doi: 10.1186/s44158-025-00290-7.
PubMed 41152963
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Thirty-degree Leg Elevation on Noradrenaline Requirements Administered as a Prophylactic Variable Infusion During Cesarean Delivery: An Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06822699
- Acronym / sponsor ID
- leg elevation and noradrenalin
- Conditions
- Spinal Hypotension, Hypoperfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 12 Feb 2025 (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.
Spinal anesthesia is a widely chosen technique in obstetric theaters due to several advantages, however sympathetic block results in hypotension that carry several consequences on maternal and fetal health, thus early prediction and management takes high priority. in this regards recent recommendations suggest the use of prophylactic vasopressors like noradrenaline, researchers of this study aimed to explore the impact of leg elevation on prophylactic noradrenaline dose
Detailed description
after spinal anesthesia, patients will be randomly allocated into 2 groups : Leg elevation group and control group.
noradrenaline will be used as variable infusion starting from 0.05 microgram/kg/min up to 0.14 microgram /kg/minute.
noradrenaline infusion will be continued till delivery of the baby
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leg elevation group | Experimental | Device: Leg elevationleg will be elevated 30 degrees immediately after spinal anesthesia |
| Control group | No intervention | –Legs will remain supine after spinal anesthesia |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- full term
- singleton pregnancy
- ASA II
Key exclusion criteria (5 listed)
- decline to participate
- baseline SBP <100 mmHg
- failed spinal anesthesia
- allergy to local anesthetic
- coagulopathy
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 |
|---|---|---|
| Leg elevationleg will be raised 30 degrees after spinal anesthesia using standardized pillow | Device | Leg elevation group |
Primary outcome
Average noradrenaline requirements
Time frame: baseline to delivery of the baby
average noradrenaline requirements in both groups (mcg/kg/min)
3 secondary outcomes
Total noradrenaline requirements
Time frame: baseline to delivery
incidence of spinal hypotension
Time frame: baseline to delivery
incidence of severe hypotension
Time frame: baseline to delivery
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 13 May 2025.
- Results publication: PubMed 28438121Hasanin A, Aiyad A, Elsakka A, Kamel A, Fouad R, Osman M, Mokhtar A, Refaat S, Hassabelnaby Y. Leg elevation decreases the incidence of post-spinal hypotension in cesarean section: a randomized controlled trial. BMC Anesthesiol. 2017 Apr 24;17(1):60. doi: 10.1186/s12871-017-0349-8.
- Results publication: PubMed 39047530Lyu W, Zhang Z, Li C, Wei P, Feng H, Zhou H, Zheng Q, Zhou J, Li J. Intravenous initial bolus during prophylactic norepinephrine infusion to prevent spinal hypotension for cesarean delivery: A randomized controlled, dose-finding trial. J Clin Anesth. 2024 Oct;97:111562. doi: 10.1016/j.jclinane.2024.111562. Epub 2024 Jul 23.
- Results publication: PubMed 30335625Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.
- Results publication: PubMed 29090733Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
- Results publication: PubMed 34034957Yu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.
- Derived from this study: PubMed 41152963Helmy MA, Naguib NN, Helmy KA, Milad LM. The influence of thirty-degree leg elevation on noradrenaline requirements administered as a prophylactic variable infusion during cesarean delivery, an open-label randomized controlled trial. J Anesth Analg Crit Care. 2025 Oct 28;5(1):73. doi: 10.1186/s44158-025-00290-7.
- Individual participant dataSharing planned: Undecided. Data will be available from corresponding author upon reasonable request
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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 Leg elevation in people with Spinal Hypotension and Hypoperfusion, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 5 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 13 May 2025. 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 Egypt. 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. 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?
Average noradrenaline requirements (time frame: baseline to delivery of the baby). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06822699, which also lists 6 linked publications.
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 13 May 2025.