Hypotension After Spinal AnesthesiaPhase 3NCT06564935
Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia
A Phase 3 study testing Heptaminol Hydrochloride in people with Hypotension After Spinal Anesthesia, run by Cairo University.
Trial summary
Methodologies and approaches have been implemented with differing degrees of success to prevent neuraxial hypotension. Currently utilized approaches to prevent hypotension during spinal anesthetic administration consist of physical precautions such as leg restraints and compression hosiery, as well as sympathomimetic… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Hypotension After Spinal Anesthesia
- What is being tested?
- Heptaminol Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Mar 2025
- Phase
- Phase 3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 50 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Undergoing elective orthopedic lower limb operations with a tourniquet or plastic surgeries under spinal anesthesia.
Who cannot join
- Patient refusal.
- History of hypertension, cardiovascular [disorders of the heart and blood vessels and including coronary heart disease, rheumatic heart disease and other conditions], and cerebrovascular diseases [conditions that affect blood flow and the blood vessels in the brain. Problems with blood flow may occur from blood vessel narrowing (stenosis), clot formation (thrombosis), artery blockage (embolism), or blood vessel rupture (hemorrhage)].
- Baseline SBP >160 mm Hg before administration of the drug.
- Any contraindications to spinal anesthesia such as coagulopathy, local skin infection, swelling, trauma, or deformity.
- Medical conditions, which release vasoconstrictors such as pheochromocytoma.
- Patients taking vasoconstrictors or uncorrected tachyarrhythmia.
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- History of drug allergy.
- Psychiatric, neuromuscular disorder, major systemic diseases.
- Pregnancy or lactating women.
- Inadequate effect of spinal anesthesia or supplemented with other types of anesthesia.
About this study
Official title: Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia in Lower Limb Surgeries With Tourniquet: A Randomized Controlled Trial
Methodologies and approaches have been implemented with differing degrees of success to prevent neuraxial hypotension. Currently utilized approaches to prevent hypotension during spinal anesthetic administration consist of physical precautions such as leg restraints and compression hosiery, as well as sympathomimetic medications Through a competitive inhibition of noradrenaline uptake, heptaminol hydrochloride prevented orthostatic hypotension and increased the plasma concentration of noradrenaline. This inhibitory effect might account for a portion of the antihypotensive effect After thorough research of the literature, studies evaluating the role of preoperative oral heptaminol hydrochloride in preventing hypotension after spinal anesthesia in lower limb surgeries with tourniquets are lacking.
- Conditions
- Hypotension After Spinal Anesthesia
- Being tested
- Heptaminol Hydrochloride, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heptaminol HydrochlorideDrug
heptaminol hydrochloride will be administrated in its solution form 4ml/kg. The mean dose used will be 25 drops = 150 mg and will be given 1.5 to 2 hours before spinal anesthesia
PlaceboDrug
Placebo drops (identical to heptaminol drops, prepared by the hospital pharmacy) will be administered 1.5 to 2 hours before spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Heptaminol hydrochloride group | Active comparator | Not described Receives: Drug: Heptaminol Hydrochloride |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
The occurrence of hypotension is defined as SBP <90 mm Hg or <80% of baseline, after spinal anesthesia. Our hypotension outcome was a binary event (yes/no) defined as the occurrence of at least 1 episode for a patient below either threshold, versus none, across the repeated measurements.
Measured: It will be assessed in the first 20 minutes after spinal anaesthesia
Secondary outcomes (2)
Changes in mean arterial blood pressure after spinal anesthesia
Duration measurement of serial changes in mean arterial blood pressure after spinal anesthesia
Measured: Every 5 minutes in the first 20 minutes after spinal anesthesia then every 15 minutes until the end of operation assessed up to 3 hours after spinal anesthesia
Changes in heart rate after spinal anesthesia
Duration measurement of serial changes in heart rate after spinal anesthesia
Measured: Every 5 minutes in the first 20 minutes after spinal anesthesia then every 15 minutes until the end of operation assessed up to 3 hours after spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startAug 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension After Spinal AnesthesiaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKhalik Mahmoud Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564935
- Sponsor's protocol ID
- MS-186-2024
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Oral Heptaminol Hydrochloride in Preventing Hypotension After Spinal Anesthesia in Lower Limb Surgeries With Tourniquet: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06564935
- Acronym / sponsor ID
- MS-186-2024
- Conditions
- Hypotension After Spinal Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 21 Aug 2024 (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.
Methodologies and approaches have been implemented with differing degrees of success to prevent neuraxial hypotension. Currently utilized approaches to prevent hypotension during spinal anesthetic administration consist of physical precautions such as leg restraints and compression hosiery, as well as sympathomimetic medications Through a competitive inhibition of noradrenaline uptake, heptaminol hydrochloride prevented orthostatic hypotension and increased the plasma concentration of noradrenaline. This inhibitory effect might account for a portion of the antihypotensive effect After thorough research of the literature, studies evaluating the role of preoperative oral heptaminol hydrochloride in preventing hypotension after spinal anesthesia in lower limb surgeries with tourniquets are lacking.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heptaminol hydrochloride group | Active comparator | Drug: Heptaminol Hydrochloride |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 18 to 50 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Undergoing elective orthopedic lower limb operations with a tourniquet or plastic surgeries under spinal anesthesia.
Key exclusion criteria (10 listed)
- Patient refusal.
- History of hypertension, cardiovascular [disorders of the heart and blood vessels and including coronary heart disease, rheumatic heart disease and other conditions], and cerebrovascular diseases [conditions that affect blood flow and the blood vessels in the brain. Problems with blood flow may occur from blood vessel narrowing (stenosis), clot formation (thrombosis), artery blockage (embolism), or blood vessel rupture (hemorrhage)].
- Baseline SBP >160 mm Hg before administration of the drug.
- Any contraindications to spinal anesthesia such as coagulopathy, local skin infection, swelling, trauma, or deformity.
- Medical conditions, which release vasoconstrictors such as pheochromocytoma.
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 |
|---|---|---|
| Heptaminol Hydrochlorideheptaminol hydrochloride will be administrated in its solution form 4ml/kg. The mean dose used will be 25 drops = 150 mg and will be given 1.5 to 2 hours before spinal anesthesia | Drug | Heptaminol hydrochloride group |
| PlaceboPlacebo drops (identical to heptaminol drops, prepared by the hospital pharmacy) will be administered 1.5 to 2 hours before spinal anesthesia. | Drug | Placebo group |
Primary outcome
Hypotension
Time frame: It will be assessed in the first 20 minutes after spinal anaesthesia
The occurrence of hypotension is defined as SBP <90 mm Hg or <80% of baseline, after spinal anesthesia. Our hypotension outcome was a binary event (yes/no) defined as the occurrence of at least 1 episode for a patient below either threshold, versus none, across the repeated measurements.
2 secondary outcomes
Changes in mean arterial blood pressure after spinal anesthesia
Time frame: Every 5 minutes in the first 20 minutes after spinal anesthesia then every 15 minutes until the end of operation assessed up to 3 hours after spinal anesthesia
Changes in heart rate after spinal anesthesia
Time frame: Every 5 minutes in the first 20 minutes after spinal anesthesia then every 15 minutes until the end of operation assessed up to 3 hours after spinal anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heptaminol Hydrochloride in people with Hypotension After Spinal Anesthesia, run by Cairo University.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Hypotension (time frame: It will be assessed in the first 20 minutes after spinal anaesthesia). 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 21 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.