Geriatric PatientNCT06972485
Comparison of Hemodynamic Effects of Hypobaric and Hyperbaric Bupivacaine in Spinal Anesthesia in Geriatric Patients
A study testing spinal anesthesia in people with Geriatric Patient and Spinal Anesthesia, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The frequency of hypotension is increased in geriatric patients due to physiological changes compared to the normal population. In this study, our aim is to compare the hemodynamic changes in geriatric patients undergoing hip surgery under spinal anesthesia with hypobaric and hyperbaric bupivacaine. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Patient, Spinal Anesthesia, Hip Surgery
- What is being tested?
- spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 30 Dec 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 65 years of age
- Patients taken to surgery in a supine position due to femur fractures
- Patients classified as ASA (American Society of Anesthesiologists) class I-III
Who cannot join
- History of allergy to the drug
- Patients with coagulopathy
- Patients refusing to participate in the study
- Severe valve stenosis
- Infection at the injection site
- Inadequate spinal anesthesia level during surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University
Eskişehir, Odunpazari, 26040
About this study
Official title: Comparison of Hemodynamic Effects of Hypobaric and Hyperbaric Bupivacaine in Spinal Anesthesia During Hip Surgery in Geriatric Patients
The frequency of hypotension is increased in geriatric patients due to physiological changes compared to the normal population. In this study, our aim is to compare the hemodynamic changes in geriatric patients undergoing hip surgery under spinal anesthesia with hypobaric and hyperbaric bupivacaine.
Read the detailed description
Patients will be randomly assigned to one of two groups: HypoB (% 0.5 bupivacaine 3cc+ 2cc distilled water) or HyperB (% 0.5 bupivacaine 3cc+ 2cc %10 dextrose). For pre-positioning analgesia, an intravenous dose of fentanyl at 0.5 mcg/kg will be administered. Patients will then be positioned in the appropriate lateral decubitus position based on whether hypobaric or hyperbaric bupivacaine is used. Spinal anesthesia will be performed using 3 cc local anesthetic solution, followed by 15 minutes of lateralization.
During the surgery, hemodynamic parameters, sensory block levels at the 5th, 10th, 15th, and 20th minutes at lateral and supine position, and motor block levels with bromage scale at the 15th and 20th minutes at supine position will be recorded. The spread of the block to the T8 dermatome level was considered an indicator of a successful block. Hemodynamic parameters (blood pressure, heart rate, peripheral oxygen saturation) will be recorded at 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, and 120 minutes intraoperatively. Patients will receive crystalloid infusion at a rate of 5-7 ml/kg per hour throughout the procedure. The volume of intraoperative bleeding, the amount of blood products administered, and the doses of ephedrine, atropine, and noradrenaline used will also be documented. If the heart rate falls below 45 beats per minute, 0.5 mg of intravenous atropine will be administered.
A decrease in blood pressure of 20% or more from baseline will be defined as hypotension. In such cases, ephedrine will be administered. If hypotension persists despite a total dose of 20 mg ephedrine, a noradrenaline infusion will be initiated.
- Conditions
- Geriatric Patient, Spinal Anesthesia, Hip Surgery
- Being tested
- spinal anesthesia
- Keywords
- Geriatric patient, Hemodynamic changes, Hypobaric bupivacaine, hyperbaric bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
spinal anesthesia with hypobaric and hyperbaric bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| HypoB | Active comparator | In the HypoB group, spinal anesthesia will be administered intrathecally using 3 cc of hypobaric bupivacaine solution in the lateral decubitus position, with the fractured side positioned upward.The patients will then be kept in the lateral position for 15 minutes. The patients' hemodynamic data , bilateral sensory and motor block levels will be recorded. Receives: Procedure: spinal anesthesia |
| HyperB | Active comparator | In the HyperB group, spinal anesthesia will be administered intrathecally using 3 cc of hyperbaric bupivacaine solution in the lateral decubitus position, with the fractured side positioned downward.The patients will then be kept in the lateral position for 15 minutes. The patients' hemodynamic data, bilateral sensory, and motor block levels will be recorded. Receives: Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic effects of hypobaric and hyperbaric bupivacaine with spinal anesthesia
blood pressure monitoring
Measured: 2 hour
Secondary outcomes (2)
Evaluation of sensorial block with hypobaric and hyperbaric bupivacaine in spinal anesthesia
sensorial block evaluate with pinprick test; sensorial block level; present/absent
Measured: 2 hour
Evaluation of motor block with hypobaric and hyperbaric bupivacaine in spinal anesthesia
motor block evaluate with bromage scale ;Grade 0: Full movement of hips, knees, and ankles (no block). Grade 1: Unable to lift the leg but can move knees and ankles (partial block). Grade 2: Unable to bend the knee but can move ankles (near-complete block). Grade 3: No movement in hips, knees, or ankles (complete block).
Measured: 2 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start15 May 2025
- Primary completion27 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Geriatric PatientStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention will be performed in geriatric patients of hemodynamic changes (hypotension, bradycardia) associated with spinal anesthesia
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadime Alagaş, Eskisehir Osmangazi University
- Investigators
- Sacit Güleç, Professor, Study director, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972485
- Sponsor's protocol ID
- FALAGAS 1
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Herrera R, De Andres J, Estan L, Olivas FJ, Martinez-Mir I, Steinfeldt T. Hemodynamic impact of isobaric levobupivacaine versus hyperbaric bupivacaine for subarachnoid anesthesia in patients aged 65 and older undergoing hip surgery. BMC Anesthesiol. 2014 Oct 24;14:97. doi: 10.1186/1471-2253-14-97. eCollection 2014.
PubMed 25371654Uppal V, Retter S, Shanthanna H, Prabhakar C, McKeen DM. Hyperbaric Versus Isobaric Bupivacaine for Spinal Anesthesia: Systematic Review and Meta-analysis for Adult Patients Undergoing Noncesarean Delivery Surgery. Anesth Analg. 2017 Nov;125(5):1627-1637. doi: 10.1213/ANE.0000000000002254.
PubMed 28708665Gong C, Ye X, Liao Y, Ye P, Zheng T, Zheng X. Hypotension after unilateral versus bilateral spinal anaesthesia: A Systematic review with meta-analysis. Eur J Anaesthesiol. 2025 Mar 1;42(3):203-223. doi: 10.1097/EJA.0000000000002098. Epub 2024 Nov 21.
PubMed 39575900
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hemodynamic Effects of Hypobaric and Hyperbaric Bupivacaine in Spinal Anesthesia During Hip Surgery in Geriatric Patients
- ClinicalTrials.gov ID
- NCT06972485
- Acronym / sponsor ID
- FALAGAS 1
- Conditions
- Geriatric Patient, Spinal Anesthesia, Hip Surgery
- Keywords
- Geriatric patient, Hemodynamic changes, Hypobaric bupivacaine, hyperbaric bupivacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 27 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 15 May 2025 (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.
The frequency of hypotension is increased in geriatric patients due to physiological changes compared to the normal population. In this study, our aim is to compare the hemodynamic changes in geriatric patients undergoing hip surgery under spinal anesthesia with hypobaric and hyperbaric bupivacaine.
Detailed description
Patients will be randomly assigned to one of two groups: HypoB (% 0.5 bupivacaine 3cc+ 2cc distilled water) or HyperB (% 0.5 bupivacaine 3cc+ 2cc %10 dextrose). For pre-positioning analgesia, an intravenous dose of fentanyl at 0.5 mcg/kg will be administered. Patients will then be positioned in the appropriate lateral decubitus position based on whether hypobaric or hyperbaric bupivacaine is used. Spinal anesthesia will be performed using 3 cc local anesthetic solution, followed by 15 minutes of lateralization.
During the surgery, hemodynamic parameters, sensory block levels at the 5th, 10th, 15th, and 20th minutes at lateral and supine position, and motor block levels with bromage scale at the 15th and 20th minutes at supine position will be recorded. The spread of the block to the T8 dermatome level was considered an indicator of a successful block. Hemodynamic parameters (blood pressure, heart rate, peripheral oxygen saturation) will be recorded at 0, 5, 10, 15, 20, 30, 40, 50, 60, 90, and 120 minutes intraoperatively. Patients will receive crystalloid infusion at a rate of 5-7 ml/kg per hour throughout the procedure. The volume of intraoperative bleeding, the amount of blood products administered, and the doses of ephedrine, atropine, and noradrenaline used will also be documented. If the heart rate falls below 45 beats per minute, 0.5 mg of intravenous atropine will be administered.
A decrease in blood pressure of 20% or more from baseline will be defined as hypotension. In such cases, ephedrine will be administered. If hypotension persists despite a total dose of 20 mg ephedrine, a noradrenaline infusion will be initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention will be performed in geriatric patients of hemodynamic changes (hypotension, bradycardia) associated with spinal anesthesia
| Arm | Type | Receives |
|---|---|---|
| HypoB | Active comparator | Procedure: spinal anesthesiaIn the HypoB group, spinal anesthesia will be administered intrathecally using 3 cc of hypobaric bupivacaine solution in the lateral decubitus position, with the fractured side positioned upward.The patients will then be kept in the lateral position for 15 minutes. The patients' hemodynamic data , bilateral sensory and motor block levels will be recorded. |
| HyperB | Active comparator | Procedure: spinal anesthesiaIn the HyperB group, spinal anesthesia will be administered intrathecally using 3 cc of hyperbaric bupivacaine solution in the lateral decubitus position, with the fractured side positioned downward.The patients will then be kept in the lateral position for 15 minutes. The patients' hemodynamic data, bilateral sensory, and motor block levels will be recorded. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients over 65 years of age
- Patients taken to surgery in a supine position due to femur fractures
- Patients classified as ASA (American Society of Anesthesiologists) class I-III
Key exclusion criteria (6 listed)
- History of allergy to the drug
- Patients with coagulopathy
- Patients refusing to participate in the study
- Severe valve stenosis
- Infection at the injection site
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 |
|---|---|---|
| spinal anesthesiaspinal anesthesia with hypobaric and hyperbaric bupivacaine | Procedure or surgery | HyperB, HypoB |
Primary outcome
Hemodynamic effects of hypobaric and hyperbaric bupivacaine with spinal anesthesia
Time frame: 2 hour
blood pressure monitoring
2 secondary outcomes
Evaluation of sensorial block with hypobaric and hyperbaric bupivacaine in spinal anesthesia
Time frame: 2 hour
Evaluation of motor block with hypobaric and hyperbaric bupivacaine in spinal anesthesia
Time frame: 2 hour
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 5 Jan 2026.
- Background: PubMed 25371654Herrera R, De Andres J, Estan L, Olivas FJ, Martinez-Mir I, Steinfeldt T. Hemodynamic impact of isobaric levobupivacaine versus hyperbaric bupivacaine for subarachnoid anesthesia in patients aged 65 and older undergoing hip surgery. BMC Anesthesiol. 2014 Oct 24;14:97. doi: 10.1186/1471-2253-14-97. eCollection 2014.
- Background: PubMed 28708665Uppal V, Retter S, Shanthanna H, Prabhakar C, McKeen DM. Hyperbaric Versus Isobaric Bupivacaine for Spinal Anesthesia: Systematic Review and Meta-analysis for Adult Patients Undergoing Noncesarean Delivery Surgery. Anesth Analg. 2017 Nov;125(5):1627-1637. doi: 10.1213/ANE.0000000000002254.
- Background: PubMed 39575900Gong C, Ye X, Liao Y, Ye P, Zheng T, Zheng X. Hypotension after unilateral versus bilateral spinal anaesthesia: A Systematic review with meta-analysis. Eur J Anaesthesiol. 2025 Mar 1;42(3):203-223. doi: 10.1097/EJA.0000000000002098. Epub 2024 Nov 21.
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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.
Sacit Güleç, Professor study director
Eskisehir Osmangazi 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 spinal anesthesia in people with Geriatric Patient and Spinal Anesthesia, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 6 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 5 Jan 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 Turkey (Türkiye). 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?
Hemodynamic effects of hypobaric and hyperbaric bupivacaine with spinal anesthesia (time frame: 2 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06972485, which also lists 3 linked publications.
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 5 Jan 2026.