Hemodynamic InstabilityPhase 3NCT06165679
Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients
A Phase 3 study testing Prilocaine and Bupivacaine in people with Hemodynamic Instability, run by Cairo University at 1 site in Egypt.
Trial summary
Data comparing prilocaine vs bupivacaine in equipotent doses in the elderly are lacking; therefore, the study will compare the effect of prilocaine vs bupivacaine on hemodynamics in spinal anesthesia for geriatric patients undergoing endoscopic urological surgeries Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Prilocaine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2023to 30 Jun 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 65 years old and above.
- Both genders.
- Patients scheduled to undergo endoscopic urological surgeries.
- ASA I and II class.
Who cannot join
- Patient refusal.
- Known local anesthetic (LA) allergy.
- Bleeding disorders.
- Skin lesions or infections at site of needle insertion.
- Hypertensive patients.
- Patients candidate for transurethral resection of the prostate
- ASA III and VI class
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients Undergoing Endoscopic Urological Surgeries: A Randomized Controlled Trial
Data comparing prilocaine vs bupivacaine in equipotent doses in the elderly are lacking; therefore, the study will compare the effect of prilocaine vs bupivacaine on hemodynamics in spinal anesthesia for geriatric patients undergoing endoscopic urological surgeries
- Conditions
- Hemodynamic Instability
- Being tested
- Prilocaine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrilocaineDrug
The patients will receive a single injection of spinal anesthesia using prilocaine plus fentanyl
BupivacaineDrug
The patients will receive a single injection of spinal anesthesia using Bupivacaine plus fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Prilocaine group | Active comparator | Not described Receives: Drug: Prilocaine |
| Bupivacaine GROUP | Active comparator | Not described Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
Incidence of hypotension from local anesthetic injection
Measured: Till 30 minutes after spinal anesthesia.
Secondary outcomes (1)
Use of vasopressor drugs
Total doses of vasopressor drugs used for hypotension treatment
Measured: Until the patient will have no lower limbs motor weakness assessed up to 6 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 posted11 Dec 2023
- Study start20 Dec 2023
- Primary completion1 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- 112 participants (actual)
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
- NCT06165679
- Sponsor's protocol ID
- N-439-2023
- Status last verified
- Jun 2025
- First submitted
- 2 Dec 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients Undergoing Endoscopic Urological Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06165679
- Acronym / sponsor ID
- N-439-2023
- Conditions
- Hemodynamic Instability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 11 Dec 2023 (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.
Data comparing prilocaine vs bupivacaine in equipotent doses in the elderly are lacking; therefore, the study will compare the effect of prilocaine vs bupivacaine on hemodynamics in spinal anesthesia for geriatric patients undergoing endoscopic urological surgeries
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prilocaine group | Active comparator | Drug: Prilocaine |
| Bupivacaine GROUP | Active comparator | Drug: Bupivacaine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients aged 65 years old and above.
- Both genders.
- Patients scheduled to undergo endoscopic urological surgeries.
- ASA I and II class.
Key exclusion criteria (7 listed)
- Patient refusal.
- Known local anesthetic (LA) allergy.
- Bleeding disorders.
- Skin lesions or infections at site of needle insertion.
- Hypertensive patients.
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 |
|---|---|---|
| PrilocaineThe patients will receive a single injection of spinal anesthesia using prilocaine plus fentanyl | Drug | Prilocaine group |
| BupivacaineThe patients will receive a single injection of spinal anesthesia using Bupivacaine plus fentanyl | Drug | Bupivacaine GROUP |
Primary outcome
Hypotension
Time frame: Till 30 minutes after spinal anesthesia.
Incidence of hypotension from local anesthetic injection
1 secondary outcome
Use of vasopressor drugs
Time frame: Until the patient will have no lower limbs motor weakness assessed up to 6 hours after spinal anesthesia
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 2 Jul 2025.
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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 Phase 3 study testing Prilocaine and Bupivacaine in people with Hemodynamic Instability, 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 4 inclusion and 7 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 2 Jul 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 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?
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?
Hypotension (time frame: Till 30 minutes after spinal anesthesia.). 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 2 Jul 2025.