Spinal HypotensionNCT07655245
Caffeine and Prophylactic Noradrenaline Requirement During Cesarean Delivery
A study testing Caffeine (200 mg) in people with Spinal Hypotension and Vasopressor, run by Cairo University at 1 site in Egypt.
Trial summary
Spinal anesthesia is the preferred regional technique in obstetric practice because it provides high maternal satisfaction and eliminates the need for airway manipulation. Despite these advantages, it is frequently complicated by spinal anesthesia-induced hypotension , defined as a reduction in systolic blood pressure… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Spinal Hypotension, Vasopressor
- What is being tested?
- Caffeine (200 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2026to 19 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 pregnant (>37 weeks)
- ASA II
- undergoing elective cesarean section.
Who cannot join
- Patient refusal
- SBP < 100 mmHg
- Allergy to local anesthetics or caffeine
- Coagulopathy (INR>1.4 or platelets <75.000)
- Preeclampsia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Cairo University Hospitals
Cairo
Mina Adolf Helmy, MD, 01275716942, minaadolf1988@cu.edu.eg
About this study
Official title: Effect of Preoperative Oral Caffeine on Prophylactic Noradrenaline Requirement During Cesarean Delivery: A Double-blind Placebo-controlled Trial
Spinal anesthesia is the preferred regional technique in obstetric practice because it provides high maternal satisfaction and eliminates the need for airway manipulation. Despite these advantages, it is frequently complicated by spinal anesthesia-induced hypotension , defined as a reduction in systolic blood pressure of more than 20% from baseline or an absolute SBP below 100 mmHg. Spinal hypotension can have serious consequences, including maternal hypoperfusion that may lead to neurological or renal dysfunction, as well as fetal acidosis and bradycardia, which can compromise neonatal outcomes. The present study aims to evaluate the effect of preoperative caffeine administration on noradrenaline requirements during spinal anesthesia in obstetric patients. Specifically, the objectives are to compare noradrenaline requirements between the study groups and to assess the incidence of hypotension in both groups.
Read the detailed description
Spinal anesthesia is considered the technique of choice in obstetric practice because it provides excellent maternal comfort and avoids the risks associated with airway manipulation during general anesthesia. Nevertheless, its use is often complicated by a significant drop in blood pressure, which can reduce blood flow to vital organs and impair maternal brain and kidney function. More importantly, decreased uteroplacental perfusion may compromise fetal oxygenation, leading to acidosis and slowing of the heart rate, both of which can negatively affect neonatal outcomes. These risks make it essential to explore preventive strategies that can stabilize blood pressure during spinal anesthesia. Caffeine, a widely available and inexpensive stimulant, enhances sympathetic nervous system activity and may counteract the vasodilation that contributes to low blood pressure. This study therefore investigates whether giving caffeine before anesthesia can reduce the need for noradrenaline, a commonly used vasopressor, and whether it can lower the incidence of hypotension. By examining these outcomes, the research aims to determine if caffeine could serve as a simple intervention to improve both maternal safety and neonatal wellbeing.
- Conditions
- Spinal Hypotension, Vasopressor
- Being tested
- Caffeine (200 mg), Placebo
- Keywords
- Spinal anesthesia induced hypotension, Vasopressor, Caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine (200 mg)Drug
Patients will receive 200 mg oral caffeine 30 minutes before spinal anesthesia
PlaceboDrug
Patient will receive placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Active comparator | 30 minutes before spinal anesthesia in the preoperative area, the patient will receive 200 mg caffeine capsule Receives: Drug: Caffeine (200 mg) |
| Control | Placebo comparator | 30 minutes before spinal anesthesia in the preoperative area, the patient will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average noradrenaline requirement
The total noradrenaline administered as an infusion plus boluses divided by patient weight and infusion time.
Measured: After spinal anesthesia till delivery
Secondary outcomes (3)
Incidence of spinal hypotension
Reduction of systolic blood pressure more than 20% of baseline
Measured: After spinal anesthesia till end of delivery
Time to first hypotensive episode
Time to develop the first hypotensive episode in minutes
Measured: After spinal anesthesia till delivery of the baby
APGAR score
Assessment of APGAR score of neonates
Measured: at 10 minutes of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start16 Jun 2026 (estimated)
- Primary completion16 Sep 2026 (estimated)
- Study completion19 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
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
- NCT07655245
- Sponsor's protocol ID
- Caffeine and noradrenaline
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At present, we have not finalized a plan for sharing individual participant data. Decisions regarding data sharing will depend on factors such as ethical approval, participant consent, and institutional policies. If sharing becomes feasible, de-identified data may be made available upon reasonable request following appropriate review.
Publications
Helmy MA, Helmy KA, Darandly WME, Awad HH, Morsy F, Kaddah RA, Shamma MA, Milad LM. Prediction of spinal anesthesia-induced hypotension during cesarean delivery: a narrative review. J Anesth Analg Crit Care. 2026 Apr 11;6(1):61. doi: 10.1186/s44158-026-00382-y.
PubMed 41964042Helmy MA, Helmy KA, Kaddah RA, Shamma MA, Ali MA, Milad LM. Femoral artery Doppler as a novel predictor of spinal hypotension in elective cesarean delivery cases: a prospective observational study. Int J Obstet Anesth. 2025 Aug;63:104706. doi: 10.1016/j.ijoa.2025.104706. Epub 2025 Jun 18.
PubMed 40550198Helmy MA, Helmy KA, Zaki RM, Khatab SA, Embaby SA, Kaddah RA, Shamma MA, Milad LM. Caffeine before cesarean delivery: a novel preventive strategy against spinal hypotension, a double blind placebo-controlled trial. J Anesth Analg Crit Care. 2026 Jan 15;6(1):12. doi: 10.1186/s44158-025-00333-z.
PubMed 41535923
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Caffeine on Prophylactic Noradrenaline Requirement During Cesarean Delivery: A Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07655245
- Acronym / sponsor ID
- Caffeine and noradrenaline
- Conditions
- Spinal Hypotension, Vasopressor
- Keywords
- Spinal anesthesia induced hypotension, Vasopressor, Caffeine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Jun 2026 (estimated)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- 19 Sep 2026 (estimated)
- First posted
- 17 Jun 2026 (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 the preferred regional technique in obstetric practice because it provides high maternal satisfaction and eliminates the need for airway manipulation. Despite these advantages, it is frequently complicated by spinal anesthesia-induced hypotension , defined as a reduction in systolic blood pressure of more than 20% from baseline or an absolute SBP below 100 mmHg. Spinal hypotension can have serious consequences, including maternal hypoperfusion that may lead to neurological or renal dysfunction, as well as fetal acidosis and bradycardia, which can compromise neonatal outcomes. The present study aims to evaluate the effect of preoperative caffeine administration on noradrenaline requirements during spinal anesthesia in obstetric patients. Specifically, the objectives are to compare noradrenaline requirements between the study groups and to assess the incidence of hypotension in both groups.
Detailed description
Spinal anesthesia is considered the technique of choice in obstetric practice because it provides excellent maternal comfort and avoids the risks associated with airway manipulation during general anesthesia. Nevertheless, its use is often complicated by a significant drop in blood pressure, which can reduce blood flow to vital organs and impair maternal brain and kidney function. More importantly, decreased uteroplacental perfusion may compromise fetal oxygenation, leading to acidosis and slowing of the heart rate, both of which can negatively affect neonatal outcomes. These risks make it essential to explore preventive strategies that can stabilize blood pressure during spinal anesthesia. Caffeine, a widely available and inexpensive stimulant, enhances sympathetic nervous system activity and may counteract the vasodilation that contributes to low blood pressure. This study therefore investigates whether giving caffeine before anesthesia can reduce the need for noradrenaline, a commonly used vasopressor, and whether it can lower the incidence of hypotension. By examining these outcomes, the research aims to determine if caffeine could serve as a simple intervention to improve both maternal safety and neonatal wellbeing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Active comparator | Drug: Caffeine (200 mg)30 minutes before spinal anesthesia in the preoperative area, the patient will receive 200 mg caffeine capsule |
| Control | Placebo comparator | Drug: Placebo30 minutes before spinal anesthesia in the preoperative area, the patient will receive placebo |
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 pregnant (>37 weeks)
- ASA II
- undergoing elective cesarean section.
Key exclusion criteria (5 listed)
- Patient refusal
- SBP < 100 mmHg
- Allergy to local anesthetics or caffeine
- Coagulopathy (INR>1.4 or platelets <75.000)
- Preeclampsia
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 |
|---|---|---|
| Caffeine (200 mg)Patients will receive 200 mg oral caffeine 30 minutes before spinal anesthesia | Drug | Caffeine |
| PlaceboPatient will receive placebo capsule | Drug | Control |
Primary outcome
Average noradrenaline requirement
Time frame: After spinal anesthesia till delivery
The total noradrenaline administered as an infusion plus boluses divided by patient weight and infusion time.
3 secondary outcomes
Incidence of spinal hypotension
Time frame: After spinal anesthesia till end of delivery
Time to first hypotensive episode
Time frame: After spinal anesthesia till delivery of the baby
APGAR score
Time frame: at 10 minutes of delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Results publication: PubMed 41964042Helmy MA, Helmy KA, Darandly WME, Awad HH, Morsy F, Kaddah RA, Shamma MA, Milad LM. Prediction of spinal anesthesia-induced hypotension during cesarean delivery: a narrative review. J Anesth Analg Crit Care. 2026 Apr 11;6(1):61. doi: 10.1186/s44158-026-00382-y.
- Results publication: PubMed 40550198Helmy MA, Helmy KA, Kaddah RA, Shamma MA, Ali MA, Milad LM. Femoral artery Doppler as a novel predictor of spinal hypotension in elective cesarean delivery cases: a prospective observational study. Int J Obstet Anesth. 2025 Aug;63:104706. doi: 10.1016/j.ijoa.2025.104706. Epub 2025 Jun 18.
- Results publication: PubMed 41535923Helmy MA, Helmy KA, Zaki RM, Khatab SA, Embaby SA, Kaddah RA, Shamma MA, Milad LM. Caffeine before cesarean delivery: a novel preventive strategy against spinal hypotension, a double blind placebo-controlled trial. J Anesth Analg Crit Care. 2026 Jan 15;6(1):12. doi: 10.1186/s44158-025-00333-z.
- Individual participant dataSharing planned: Undecided. At present, we have not finalized a plan for sharing individual participant data. Decisions regarding data sharing will depend on factors such as ethical approval, participant consent, and institutional policies. If sharing becomes feasible, de-identified data may be made available upon reasonable request following appropriate review.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine (200 mg) in people with Spinal Hypotension and Vasopressor, 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: opening soon, as of the sponsor's last update on 17 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mina Adolf Helmy, MD (01275716942, minaadolf1988@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average noradrenaline requirement (time frame: After spinal anesthesia till delivery). 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 NCT07655245, which also lists 3 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 17 Jun 2026.