- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520695
Delayed Supine Position Post-Spinal Compared With Immediate Supine Position in Geriatric Patients
April 2, 2026 updated by: Amir M Shabana, Sohar Hospital
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sohar, Oman
- Sohar Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria: Geriatric patients (aged 65 years and above) scheduled for surgical fixation of fracture neck of femur under spinal anesthesia were eligible for inclusion
-
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: putting patients immediately in a supine position after spinal anesthesia
|
we put patient in supine position after given spinal immediately
|
|
Experimental: keeping the patient 2 minutes setting after spinal anesthesia
|
impact of keeping the patient setting 2 minutes after spinal anesthesia on blood pressure in geriatric patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Postprocedural for 2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2025
Primary Completion (Actual)
January 1, 2026
Study Completion (Actual)
January 1, 2026
Study Registration Dates
First Submitted
March 16, 2026
First Submitted That Met QC Criteria
April 2, 2026
First Posted (Actual)
April 9, 2026
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 2, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MoH/CSR/25/29207
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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