Spinal HypotensionNCT07076654
Oral Caffeine and Spinal-Induced Hypotension
A study testing Caffeine (200 mg) in people with Spinal Hypotension and Caffeine, run by Cairo University at 1 site in Egypt.
Trial summary
Hypotension after spinal anesthesia is critical. Thus several interventions have been proposed to mitigate such effect. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Spinal Hypotension, Caffeine
- 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
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2025to 2 Oct 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 pregnant
- undergoing elective cesarean delivery
Who cannot join
- patient refusal
- baseline systolic pressure < 100 mmHg
- contraindication to spinal anesthesia
- allergy to caffeine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Preoperative Oral Caffeine in Preventing Spinal-Induced Hypotension During Cesarean Delivery: A Double Blind Randomized Controlled Trial
Hypotension after spinal anesthesia is critical. Thus several interventions have been proposed to mitigate such effect.
Read the detailed description
Hypotension is a critical issue related to spinal anesthesia during cesarean delivery. Researchers of this study aimed to evaluate the impact of preoperative oral caffeine on the incidence of spinal hypotension during cesarean delivery.
- Conditions
- Spinal Hypotension, Caffeine
- Being tested
- Caffeine (200 mg), Placebo
- Keywords
- Spinal hypotension, Caffeine, Cesarean delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine (200 mg)Drug
Oral caffeine will be given as 200 mg before spinal anesthesia
PlaceboDrug
Patient at this arm will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Active comparator | Patients will receive oral caffeine 200 mg before spinal anesthesia Receives: Drug: Caffeine (200 mg) |
| Control group | Placebo comparator | Will receive placebo before spinal anesthesia Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of spinal hypotension
Decrease systolic blood pressure < 20% of baseline value
Measured: After spinal anesthesia till delivery
Secondary outcomes (4)
Time to first hypotensive episode
time to incidence of hypotension
Measured: after induction of spinal anesthesia
Incidence of severe hypotension
reduced systolic pressure < 60% of baseline value
Measured: After onset of spinal anesthesia
APGAR score
APGAR score calculation at 5 minutes
Measured: at 5 minutes after delivery
Umbilical artery pH
Umbilical artery blood gases
Measured: At 5 minutes after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start12 Jul 2025
- Primary completion1 Oct 2025
- Study completion2 Oct 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 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
- NCT07076654
- Sponsor's protocol ID
- Caffeine and hypotension
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) will not be shared due to concerns regarding participant privacy and confidentiality. Although data may be de-identified, there remains a risk of re-identification, especially in studies involving small sample sizes or sensitive health information.
Publications
Grosso G, Godos J, Galvano F, Giovannucci EL. Coffee, Caffeine, and Health Outcomes: An Umbrella Review. Annu Rev Nutr. 2017 Aug 21;37:131-156. doi: 10.1146/annurev-nutr-071816-064941.
PubMed 28826374Antar SS, Metaweh A, Neamatallah H, Abdelfattah M, Abdelbaser I, Awad KA. Preoperative oral caffeine as prophylaxis against post-spinal hypotension in patients undergoing orthopedic lower limb surgery: A randomized, placebo-controlled, double-blinded study. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101537. doi: 10.1016/j.accpm.2025.101537. Epub 2025 May 1.
PubMed 40318850Helmy 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 40550198Adolf Helmy M, Mansour M, Magdy Milad L, Mohammed Aboelregal E, Magdy Youssef M. Change in femoral artery pulsatility index as a novel predictor of post-spinal anesthesia hypotension in adult patients undergoing infra-umbilical surgeries: A prospective observational study. Anaesth Crit Care Pain Med. 2025 Apr;44(2):101482. doi: 10.1016/j.accpm.2025.101482. Epub 2025 Jan 21. No abstract available.
PubMed 39848332Kinsella 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 29090733Helmy 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Preoperative Oral Caffeine in Preventing Spinal-Induced Hypotension During Cesarean Delivery: A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07076654
- Acronym / sponsor ID
- Caffeine and hypotension
- Conditions
- Spinal Hypotension, Caffeine
- Keywords
- Spinal hypotension, Caffeine, Cesarean delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jul 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 22 Jul 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.
Hypotension after spinal anesthesia is critical. Thus several interventions have been proposed to mitigate such effect.
Detailed description
Hypotension is a critical issue related to spinal anesthesia during cesarean delivery. Researchers of this study aimed to evaluate the impact of preoperative oral caffeine on the incidence of spinal hypotension during cesarean delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Active comparator | Drug: Caffeine (200 mg)Patients will receive oral caffeine 200 mg before spinal anesthesia |
| Control group | Placebo comparator | Drug: PlaceboWill receive placebo before spinal anesthesia |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- full term pregnant
- undergoing elective cesarean delivery
Key exclusion criteria (4 listed)
- patient refusal
- baseline systolic pressure < 100 mmHg
- contraindication to spinal anesthesia
- allergy to caffeine
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)Oral caffeine will be given as 200 mg before spinal anesthesia | Drug | Caffeine |
| PlaceboPatient at this arm will receive placebo | Drug | Control group |
Primary outcome
Incidence of spinal hypotension
Time frame: After spinal anesthesia till delivery
Decrease systolic blood pressure < 20% of baseline value
4 secondary outcomes
Time to first hypotensive episode
Time frame: after induction of spinal anesthesia
Incidence of severe hypotension
Time frame: After onset of spinal anesthesia
APGAR score
Time frame: at 5 minutes after delivery
Umbilical artery pH
Time frame: At 5 minutes after 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 18 Dec 2025.
- Results publication: PubMed 28826374Grosso G, Godos J, Galvano F, Giovannucci EL. Coffee, Caffeine, and Health Outcomes: An Umbrella Review. Annu Rev Nutr. 2017 Aug 21;37:131-156. doi: 10.1146/annurev-nutr-071816-064941.
- Results publication: PubMed 40318850Antar SS, Metaweh A, Neamatallah H, Abdelfattah M, Abdelbaser I, Awad KA. Preoperative oral caffeine as prophylaxis against post-spinal hypotension in patients undergoing orthopedic lower limb surgery: A randomized, placebo-controlled, double-blinded study. Anaesth Crit Care Pain Med. 2025 Aug;44(4):101537. doi: 10.1016/j.accpm.2025.101537. Epub 2025 May 1.
- 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 39848332Adolf Helmy M, Mansour M, Magdy Milad L, Mohammed Aboelregal E, Magdy Youssef M. Change in femoral artery pulsatility index as a novel predictor of post-spinal anesthesia hypotension in adult patients undergoing infra-umbilical surgeries: A prospective observational study. Anaesth Crit Care Pain Med. 2025 Apr;44(2):101482. doi: 10.1016/j.accpm.2025.101482. Epub 2025 Jan 21. No abstract available.
- 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.
- Derived from this study: 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. Individual Participant Data (IPD) will not be shared due to concerns regarding participant privacy and confidentiality. Although data may be de-identified, there remains a risk of re-identification, especially in studies involving small sample sizes or sensitive health information.
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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 Caffeine (200 mg) in people with Spinal Hypotension and Caffeine, 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 2 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 18 Dec 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. 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?
Incidence of spinal hypotension (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 NCT07076654, 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 18 Dec 2025.