Post Spinal HypotensionPhase 1NCT07034911
Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery
A Phase 1 study testing Ketalar and Ephedrine in people with Post Spinal Hypotension, run by Ain Shams University at 1 site in Egypt.
Trial summary
Comparing ketamine and ephedrine to decrease the incidence of post spinal hypotension after caesarean section delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Spinal Hypotension
- What is being tested?
- Ketalar and Ephedrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 15 Sep 2024
- Phase
- Phase 1
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing Caesarian Section under spinal anesthesia,
- Patients aged 18-45 years,
- At term (≥37-week gestation),
- American Society of Anaesthesiologists (ASA) physical status 1 or 2 Exclusion Criteria:
- Pre-eclampsia,
- Chronic hypertension, cardiovascular troubles,
Show all 10Show fewer
- Any contraindication to regional anesthesia such as local infection or bleeding disorders,
- Any hypersensitivity to ketamine.
- Declined informed consent.
- American Society of Anaesthesiologists (ASA) physical status lll or lV
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Sub-anaesthetic Dose of Ketamine Versus Ephedrine on Post Spinal Hypotension in Caesarean Delivery
Comparing ketamine and ephedrine to decrease the incidence of post spinal hypotension after caesarean section delivery.
Read the detailed description
To compare the effect of ketamine versus ephedrine in decreasing the incidence of hypotension in caesarean section delivery a study group including 50 participants will receive ketamine and 50 group will receive ephedrine after the consent and detailed history the two groups will receive preload of 500ml enter acetate then dormicum for sedation then spinal anesthesia will be performed initial blood pressure and heart rate will be measured then every five minutes
- Conditions
- Post Spinal Hypotension
- Being tested
- Ketalar, Ephedrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetalarDrug
Also called Ketamine
women receiving sub-anesthetic dose of ketamine of 0.5 mg/kg IV bolus in 3 ml of normal saline.
EphedrineDrug
women receiving bolus of 15mg of ephedrine
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group | Active comparator | 0.5mg/kg ketamine Receives: Drug: Ketalar |
| Ephedrine group | Active comparator | 15 mg ephedrine Receives: Drug: Ephedrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension post spinal in CS
For ketamine Group: women receiving sub-anesthetic dose of ketamine of 0.5 mg/kg IV bolus in 3 ml of normal saline. ( Reves JG et al,2010 )
- For ephedrine Group: women receiving bolus of 15mg of ephedrine
- All the patients will receive 2 mg midazolam IV directly after delivery of the fetus.( Perumal DK et al )
- Heart Rate (HR) and Mean Arterial Blood Pressure (MAP) will be recorded at baseline 5 minutes prior to the intrathecal injection and 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection and then every 15 minutes till the end of the operation.
- Incidence of hypotension will be recorded which is defined as MAP less than 20% below the baseline or was ≤ 65 mmHg. Incidence of severe hypotension ≤ 50 mmHg will be recorded.
Measured: From injection till the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Apr 2024
- Primary completion1 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Spinal HypotensionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Basant E Mohamed, M.B.B.CH, Principal investigator, Anesthesia resident Alain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034911
- Sponsor's protocol ID
- FMASU MS130/2024
- Status last verified
- Mar 2024
- First submitted
- 15 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sub-anaesthetic Dose of Ketamine Versus Ephedrine on Post Spinal Hypotension in Caesarean Delivery
- ClinicalTrials.gov ID
- NCT07034911
- Acronym / sponsor ID
- FMASU MS130/2024
- Conditions
- Post Spinal Hypotension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 24 Jun 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.
Comparing ketamine and ephedrine to decrease the incidence of post spinal hypotension after caesarean section delivery.
Detailed description
To compare the effect of ketamine versus ephedrine in decreasing the incidence of hypotension in caesarean section delivery a study group including 50 participants will receive ketamine and 50 group will receive ephedrine after the consent and detailed history the two groups will receive preload of 500ml enter acetate then dormicum for sedation then spinal anesthesia will be performed initial blood pressure and heart rate will be measured then every five minutes
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine group | Active comparator | Drug: Ketalar0.5mg/kg ketamine |
| Ephedrine group | Active comparator | Drug: Ephedrine15 mg ephedrine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patients undergoing Caesarian Section under spinal anesthesia,
- Patients aged 18-45 years,
- At term (≥37-week gestation),
- American Society of Anaesthesiologists (ASA) physical status 1 or 2 Exclusion Criteria:
- Pre-eclampsia,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| KetalarAlso: Ketaminewomen receiving sub-anesthetic dose of ketamine of 0.5 mg/kg IV bolus in 3 ml of normal saline. | Drug | Ketamine group |
| Ephedrinewomen receiving bolus of 15mg of ephedrine | Drug | Ephedrine group |
Primary outcome
Incidence of hypotension post spinal in CS
Time frame: From injection till the end of surgery
For ketamine Group: women receiving sub-anesthetic dose of ketamine of 0.5 mg/kg IV bolus in 3 ml of normal saline. ( Reves JG et al,2010 ) * For ephedrine Group: women receiving bolus of 15mg of ephedrine * All the patients will receive 2 mg midazolam IV directly after delivery of the fetus.( Perumal DK et al ) * Heart Rate (HR) and Mean Arterial Blood Pressure (MAP) will be recorded at baseline 5 minutes prior to the intrathecal injection and 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection and then every 15 minutes till the end of the operation. * Incidence of hypotension will be recorded which is defined as MAP less than 20% below the baseline or was ≤ 65 mmHg. Incidence of severe hypotension ≤ 50 mmHg will be recorded.
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 24 Jun 2025.
- Individual participant dataSharing planned: Yes. All data will be shared
Related trials for Post Spinal Hypotension
RecruitingObservational study
The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
Postspinal Hypotension, Cesarean Birth
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
RecruitingPhase 4
Norepinephrine With Ephedrine Versus Norepinephrine Alone During Spinal Anesthesia for Cesarean Delivery
Incidence of Post-spinal Hypotension
Not yet recruiting
Comparing Spinal, Epidural, and Dural Puncture Epidural Anesthesia for Cesarean Delivery: Hemodynamics and Block Quality
Hypotension After Neuraxial Anesthesia, Cesarean Section
RecruitingObservational study
Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery
Hypotension, Spinal Anesthesia
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.
Basant E Mohamed, M.B.B.CH principal investigator
Anesthesia resident Alain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketalar and Ephedrine in people with Post Spinal Hypotension, run by Ain Shams 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 10 inclusion and 0 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 24 Jun 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 hypotension post spinal in CS (time frame: From injection till the end of surgery). 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 24 Jun 2025.