Hip FracturesNCT06583213
Conventional Spinal Anaesthesia Versus Fractional Spinal Anaesthesia on Hemodynamics
A study testing Fractional Spinal Anaesthesia. and Conventional Spinal Anaesthesia in people with Hip Fractures, run by Ain Shams University at 1 site in Egypt.
Trial summary
compare the systemic haemodynamic response to fractional spinal anaesthesia versus conventional spinal anaesthesia , in a group of elderly and comorbid patients with hip fracture. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Fractional Spinal Anaesthesia. and Conventional Spinal Anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 May 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hip fractures.
- Patients age >60 years old.
- ASA ≤ 3. Patients with a CFS score ≥5
Who cannot join
- Patients on anticoagulant medication.
- Planned for general anaesthesia .
- Patients had atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Conventional Spinal Anaesthesia and Fractional Spinal Anaesthesia on Systemic Haemodynamics in Frail Elderly Hip Fracture Patients
compare the systemic haemodynamic response to fractional spinal anaesthesia versus conventional spinal anaesthesia , in a group of elderly and comorbid patients with hip fracture.
Read the detailed description
Spinal anaesthesia affects sympathetic chain activity, leading to a reduction in vasomotor tone.It was found that the incidence of hypotension following single-shot spinal anaesthesia, has previously been described as being 28-69%. As a matter of fact, autonomic nervous system function plays a key role in the development of haemodynamic instability and intraoperative hypotension . Haemodynamic stability should be considered as a primary intraoperative target, since several findings suggest avoiding systemic pressure drops . It was found that hypotension is primarily related to the overall dose injected ; however, several other variables, including the volume, the type of the anaesthetics injected, different adjuvant agents, and pre- and intraoperative factors, may impact the haemodynamic effect of the SA.
- Conditions
- Hip Fractures
- Being tested
- Fractional Spinal Anaesthesia., Conventional Spinal Anaesthesia
- Keywords
- fractional spinal
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional Spinal Anaesthesia.Procedure or surgery
An intrathecal catheter 20 G will be then inserted 2-3 cm into the intrathecal space.This technique of SA will be performed on all patients , the needle should be inserted between L3 and L4 space or L4 and L5 space in order to avoid injury to the spinal cord. An intrathecal mixture (5mL) containing 3 mg/ml hyperbaric bupivacaine and 1 μg/ml dexmedetomidine will be prepared. Intrathecal anaesthesia will be induced by giving 2 mL (6 mg of hyperbaric bupivacaine and 2 μg of dexmedetomidine ) of the mixture, followed by a second 2 mL injection after 12 min. (i.e., a total intrathecal dose (4mL) of 12 mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ).
Conventional Spinal AnaesthesiaProcedure or surgery
Intrathecal anaesthesia will be induced by giving 12.5 mg Hyperbaric bupivacaine (2.5mL) and 4 μg of dexmedetomidine (1mL) (i.e., a total intrathecal dose (3.5 mL) of 12.5mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ). (Mohamed T et al., 2017).
Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every minute up to 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Fractional Spinal Anaesthesia. Group A. | Experimental | An intrathecal catheter 20 G will be then inserted 2-3 cm into the intrathecal space.This technique of SA will be performed on all patients , the needle should be inserted between L3 and L4 space or L4 and L5 space in order to avoid injury to the spinal cord. An intrathecal mixture (5mL) containing 3 mg/ml hyperbaric bupivacaine and 1 μg/ml dexmedetomidine will be prepared. Intrathecal anaesthesia will be induced by giving 2 mL (6 mg of hyperbaric bupivacaine and 2 μg of dexmedetomidine ) of the mixture, followed by a second 2 mL injection after 12 min. Receives: Procedure: Fractional Spinal Anaesthesia.; Procedure: Conventional Spinal Anaesthesia |
| Conventional Spinal Anaesthesia. Group B. | Active comparator | Intrathecal anaesthesia will be induced by giving 12.5 mg Hyperbaric bupivacaine (2.5mL) and 4 μg of dexmedetomidine (1mL) (i.e., a total intrathecal dose (3.5 mL) of 12.5mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ).
Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every minute up to 30 minutes. Receives: Procedure: Fractional Spinal Anaesthesia.; Procedure: Conventional Spinal Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is to measure blood pressure change intra-operative operative operative (2 hours)
blood pressure monitoring
Measured: 2 hours
Secondary outcomes (1)
Postoperative pain score for 24 hours
pain score using the Visual Analogue Scale
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Sep 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ahmed saudi, professor, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583213
- Sponsor's protocol ID
- FMASU MD76/2024
- Status last verified
- May 2024
- First submitted
- 23 Jun 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Conventional Spinal Anaesthesia and Fractional Spinal Anaesthesia on Systemic Haemodynamics in Frail Elderly Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT06583213
- Acronym / sponsor ID
- FMASU MD76/2024
- Conditions
- Hip Fractures
- Keywords
- fractional spinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 3 Sep 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.
compare the systemic haemodynamic response to fractional spinal anaesthesia versus conventional spinal anaesthesia , in a group of elderly and comorbid patients with hip fracture.
Detailed description
Spinal anaesthesia affects sympathetic chain activity, leading to a reduction in vasomotor tone.It was found that the incidence of hypotension following single-shot spinal anaesthesia, has previously been described as being 28-69%. As a matter of fact, autonomic nervous system function plays a key role in the development of haemodynamic instability and intraoperative hypotension . Haemodynamic stability should be considered as a primary intraoperative target, since several findings suggest avoiding systemic pressure drops . It was found that hypotension is primarily related to the overall dose injected ; however, several other variables, including the volume, the type of the anaesthetics injected, different adjuvant agents, and pre- and intraoperative factors, may impact the haemodynamic effect of the SA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractional Spinal Anaesthesia. Group A. | Experimental | Procedure: Fractional Spinal Anaesthesia., Procedure: Conventional Spinal AnaesthesiaAn intrathecal catheter 20 G will be then inserted 2-3 cm into the intrathecal space.This technique of SA will be performed on all patients , the needle should be inserted between L3 and L4 space or L4 and L5 space in order to avoid injury to the spinal cord. An intrathecal mixture (5mL) containing 3 mg/ml hyperbaric bupivacaine and 1 μg/ml dexmedetomidine will be prepared. Intrathecal anaesthesia will be induced by giving 2 mL (6 mg of hyperbaric bupivacaine and 2 μg of dexmedetomidine ) of the mixture, followed by a second 2 mL injection after 12 min. |
| Conventional Spinal Anaesthesia. Group B. | Active comparator | Procedure: Fractional Spinal Anaesthesia., Procedure: Conventional Spinal AnaesthesiaIntrathecal anaesthesia will be induced by giving 12.5 mg Hyperbaric bupivacaine (2.5mL) and 4 μg of dexmedetomidine (1mL) (i.e., a total intrathecal dose (3.5 mL) of 12.5mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ). Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every minute up to 30 minutes. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with hip fractures.
- Patients age >60 years old.
- ASA ≤ 3. Patients with a CFS score ≥5
Key exclusion criteria (3 listed)
- Patients on anticoagulant medication.
- Planned for general anaesthesia .
- Patients had atrial fibrillation.
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 |
|---|---|---|
| Fractional Spinal Anaesthesia.An intrathecal catheter 20 G will be then inserted 2-3 cm into the intrathecal space.This technique of SA will be performed on all patients , the needle should be inserted between L3 and L4 space or L4 and L5 space in order to avoid injury to the spinal cord. An intrathecal mixture (5mL) containing 3 mg/ml hyperbaric bupivacaine and 1 μg/ml dexmedetomidine will be prepared. Intrathecal anaesthesia will be induced by giving 2 mL (6 mg of hyperbaric bupivacaine and 2 μg of dexmedetomidine ) of the mixture, followed by a second 2 mL injection after 12 min. (i.e., a total intrathecal dose (4mL) of 12 mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ). | Procedure or surgery | Conventional Spinal Anaesthesia. Group B., Fractional Spinal Anaesthesia. Group A. |
| Conventional Spinal AnaesthesiaIntrathecal anaesthesia will be induced by giving 12.5 mg Hyperbaric bupivacaine (2.5mL) and 4 μg of dexmedetomidine (1mL) (i.e., a total intrathecal dose (3.5 mL) of 12.5mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ). (Mohamed T et al., 2017). Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every minute up to 30 minutes. | Procedure or surgery | Conventional Spinal Anaesthesia. Group B., Fractional Spinal Anaesthesia. Group A. |
Primary outcome
Is to measure blood pressure change intra-operative operative operative (2 hours)
Time frame: 2 hours
blood pressure monitoring
1 secondary outcome
Postoperative pain score for 24 hours
Time frame: within 24 hours
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 31 Aug 2026.
- Individual participant dataSharing planned: No
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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.
ahmed saudi, professor study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional Spinal Anaesthesia. and Conventional Spinal Anaesthesia in people with Hip Fractures, 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 3 inclusion and 3 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 31 Aug 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. 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?
Is to measure blood pressure change intra-operative operative operative (2 hours) (time frame: 2 hours). 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 31 Aug 2026.