we Study the Effect of Keeping the Patient Supine 2 Minutes After Spinal Anesthesia in Geriatric GroupsPhase 2NCT07520695
Delayed Supine Position Post-Spinal Compared With Immediate Supine Position in Geriatric Patients
A Phase 2 study testing 2 minutes setting post spinal anesthesia and immediate supine position in people with we Study the Effect of Keeping the Patient Supine 2 Minutes After Spinal Anesthesia in Geriatric Groups, run by Sohar Hospital at 1 site in Oman.
Trial summary
Background: Geriatric patients undergoing femoral neck of fracture (FNOF) repair are highly susceptible to spinal anesthesia-induced hypotension. This study examines whether a two-minute delayed supine position after spinal injection reduces this risk. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- we Study the Effect of Keeping the Patient Supine 2 Minutes After Spinal Anesthesia in Geriatric Groups
- What is being tested?
- 2 minutes setting post spinal anesthesia and immediate supine position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteOman
- Study dates
- 1 Jan 2025to 1 Jan 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Contraindications to spinal anesthesia (e.g., coagulopathy, local infection, etc.).
- Haemodynamic instability or baseline systolic BP < 90 mmHg.
- Allergy to study medications.
- ASA 4.
- Morbidly obese patients (BMI>40).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Two Minutes Delayed Supine Position Post-Spinal Compared With Immediate Supine Position in Geriatric Patients Undergoing Repair of Fracture Neck of Femur: A Randomized Controlled Trial
Background: Geriatric patients undergoing femoral neck of fracture (FNOF) repair are highly susceptible to spinal anesthesia-induced hypotension. This study examines whether a two-minute delayed supine position after spinal injection reduces this risk. Methods: Ninety patients aged ≥65 years undergoing FNOF surgery under spinal anesthesia were randomized into two groups. Group D remained seated for two minutes post-spinal injection; Group I was positioned supine immediately. Hemo-dynamic parameters, recorded as primary outcomes, other parameters like vasopressor use, maximum sensory level achieved, duration of surgery, and fluid administration as secondary outcomes.
- Being tested
- 2 minutes setting post spinal anesthesia, immediate supine position
- Keywords
- supine, post-spinal, geriatric, delayed
- Medical subject headings
- Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 minutes setting post spinal anesthesiaProcedure or surgery
impact of keeping the patient setting 2 minutes after spinal anesthesia on blood pressure in geriatric patients
immediate supine positionProcedure or surgery
we put patient in supine position after given spinal immediately
| Study group | Role | What they receive |
|---|---|---|
| putting patients immediately in a supine position after spinal anesthesia | Active comparator | Not described Receives: Procedure: immediate supine position |
| keeping the patient 2 minutes setting after spinal anesthesia | Experimental | Not described Receives: Procedure: 2 minutes setting post spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension after spinal anesthesia in both groups
Hypotension is defined by systolic blood pressure below 90 mmHg or mean arterial BP less than 25% of the basal
Measured: Postprocedural for 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jan 2025
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for we Study the Effect of Keeping the Patient Supine 2 Minutes After Spinal Anesthesia in Geriatric GroupsStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohar Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amir M Shabana, Sohar Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520695
- Sponsor's protocol ID
- MoH/CSR/25/29207
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 9 Apr 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 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Two Minutes Delayed Supine Position Post-Spinal Compared With Immediate Supine Position in Geriatric Patients Undergoing Repair of Fracture Neck of Femur: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07520695
- Acronym / sponsor ID
- MoH/CSR/25/29207
- Keywords
- supine, post-spinal, geriatric, delayed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sohar HospitalOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 9 Apr 2026 (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.
Background: Geriatric patients undergoing femoral neck of fracture (FNOF) repair are highly susceptible to spinal anesthesia-induced hypotension. This study examines whether a two-minute delayed supine position after spinal injection reduces this risk. Methods: Ninety patients aged ≥65 years undergoing FNOF surgery under spinal anesthesia were randomized into two groups. Group D remained seated for two minutes post-spinal injection; Group I was positioned supine immediately. Hemo-dynamic parameters, recorded as primary outcomes, other parameters like vasopressor use, maximum sensory level achieved, duration of surgery, and fluid administration as secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| putting patients immediately in a supine position after spinal anesthesia | Active comparator | Procedure: immediate supine position |
| keeping the patient 2 minutes setting after spinal anesthesia | Experimental | Procedure: 2 minutes setting post spinal anesthesia |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Contraindications to spinal anesthesia (e.g., coagulopathy, local infection, etc.).
- Haemodynamic instability or baseline systolic BP < 90 mmHg.
- Allergy to study medications.
- ASA 4.
- Morbidly obese patients (BMI>40).
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 |
|---|---|---|
| 2 minutes setting post spinal anesthesiaimpact of keeping the patient setting 2 minutes after spinal anesthesia on blood pressure in geriatric patients | Procedure or surgery | keeping the patient 2 minutes setting after spinal anesthesia |
| immediate supine positionwe put patient in supine position after given spinal immediately | Procedure or surgery | putting patients immediately in a supine position after spinal anesthesia |
Primary outcome
Incidence of hypotension after spinal anesthesia in both groups
Time frame: Postprocedural for 2 hours
Hypotension is defined by systolic blood pressure below 90 mmHg or mean arterial BP less than 25% of the basal
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 9 Apr 2026.
- Individual participant dataSharing planned: No
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 2 study testing 2 minutes setting post spinal anesthesia and immediate supine position in people with we Study the Effect of Keeping the Patient Supine 2 Minutes After Spinal Anesthesia in Geriatric Groups, run by Sohar Hospital at 1 site in Oman.
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 0 inclusion and 5 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 9 Apr 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 Oman. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 after spinal anesthesia in both groups (time frame: Postprocedural for 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 9 Apr 2026.