Anesthesia, SpinalNCT05896631
The Effect of Spinal Anesthesia on Hemodynamics
A study testing 7.5 mg hyperbaric bupivacaine and 5 mg hyperbaric bupivacaine in people with Anesthesia, Spinal, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
In this study, it was planned to provide more stable hemodynamics in geriatric patients with low-dose spinal anesthesia. We will compare 7.5mg hyperbaric bupivacaine with 5mg hyperbaric bupivacaine. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Spinal
- What is being tested?
- 7.5 mg hyperbaric bupivacaine and 5 mg hyperbaric bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2023to 1 Oct 2023
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- ASA(American Society of Anesthesiologists) I-II-III patients
- BMI( body mass index) in the range of 18-40
- over 65 years old hip fracture
Who cannot join
- Refusal to participate in the study
- Left ventricular ejection fraction below 40%
- cardiac arrhythmia
- Patients with peripheral vascular disease
- Failure of spinal anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
Official title: The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients
In this study, it was planned to provide more stable hemodynamics in geriatric patients with low-dose spinal anesthesia. We will compare 7.5mg hyperbaric bupivacaine with 5mg hyperbaric bupivacaine.
The researchers hypothesized that low-dose bupivacaine would provide adequate anesthesia, less hypotension, and faster recovery.
Read the detailed description
Hypothesis It is hypothesized that low-dose bupivacaine can provide adequate anesthesia, less hypotension, and faster recovery.
patient population Patients over 65 years of age who will undergo spinal anesthesia due to hip fracture.
Hemodynamic data(Blood pressure-mmHg, heart rate-beats per minute) of patients, bromage scores, perfusion index (PI) values, discharge time, pain with NRS (numerical rating scale), patient satisfaction will be evaluated ( Numeric output from 1-10).
Hemodynamic variables will be recorded every 2 minutes in the first 20 minutes after spinal anesthesia. hemodynamic variables will be recorded 30 minutes after spinal anesthesia and at the end of the operation.
The perfusion index is the ratio of the blood volume to the pulsatile to non-pulsatile fraction. An increase in the pulsatile fraction that occurs during vasodilation corresponds to a higher PI. Therefore, patients with a higher PI have a higher risk of post-spinal hypotension.
- Conditions
- Anesthesia, Spinal
- Being tested
- 7.5 mg hyperbaric bupivacaine, 5 mg hyperbaric bupivacaine
- Keywords
- hemodynamic management, spinal anesthesia, geriatric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.5 mg hyperbaric bupivacaineOther
Spinal anesthesia with 7.5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block
5 mg hyperbaric bupivacaineOther
Spinal anesthesia with 5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block
| Study group | Role | What they receive |
|---|---|---|
| 7.5 mg hyperbaric bupivacaine | Active comparator | Patients undergoing spinal anesthesia in the lateral decubitus position with 7.5 mg of hyperbaric bupivacaine will be included. Receives: Other: 7.5 mg hyperbaric bupivacaine |
| 5 mg hyperbaric bupivacaine | Active comparator | Patients undergoing spinal anesthesia in the lateral decubitus position with 5 mg of hyperbaric bupivacaine will be included. Receives: Other: 5 mg hyperbaric bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic variability
intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery
Measured: every 2 minutes for the first 20 minutes after spinal anesthesia
hemodynamic variability
intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery
Measured: at 30 minutes of spinal anesthesia
Secondary outcomes (11)
perfusion index variability
To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
Measured: every 2 minutes for the first 20 minutes after spinal anesthesia
perfusion index variability
To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
Measured: at 30 minutes of spinal anesthesia
perfusion index variability
To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
Measured: at the end of the operation
Sensory Levels
Sensory levels will be measured every 30 minutes until discharge from PACU(post-anaesthesia care unit)
Measured: 24 hours
ephedrine use
ephedrine consumption , mg in hip surgery
Measured: 24 hours
fentanyl use
fentanyl consumption , mcg in hip surgery
Measured: 24 hours
bromage scale
Bromage Scores every 30 minutes until discharge from PACU(post-anaesthesia care unit).
Measured: 24 hours
NRS(numerical rating scale)
pain scoring a score of 1 to 10
Measured: 2 hours
NRS(numerical rating scale)
pain scoring a score of 1 to 10
Measured: 8 hours
NRS(numerical rating scale)
pain scoring a score of 1 to 10
Measured: 16 hours
NRS(numerical rating scale)
pain scoring a score of 1 to 10
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start8 Jun 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kavak Akelma, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896631
- Sponsor's protocol ID
- geriatrics
- Status last verified
- Jul 2024
- First submitted
- 22 May 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mafizer M, Kavak Akelma F, Nalbant B. Impact of bupivacaine dose on haemodynamics in elderly hip surgery: a randomized controlled trial. BMC Geriatr. 2026 Mar 26;26(1):630. doi: 10.1186/s12877-026-07374-1.
PubMed 41882562
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients
- ClinicalTrials.gov ID
- NCT05896631
- Acronym / sponsor ID
- geriatrics
- Conditions
- Anesthesia, Spinal
- Keywords
- hemodynamic management, spinal anesthesia, geriatric anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 9 Jun 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.
In this study, it was planned to provide more stable hemodynamics in geriatric patients with low-dose spinal anesthesia. We will compare 7.5mg hyperbaric bupivacaine with 5mg hyperbaric bupivacaine.
The researchers hypothesized that low-dose bupivacaine would provide adequate anesthesia, less hypotension, and faster recovery.
Detailed description
Hypothesis It is hypothesized that low-dose bupivacaine can provide adequate anesthesia, less hypotension, and faster recovery.
patient population Patients over 65 years of age who will undergo spinal anesthesia due to hip fracture.
Hemodynamic data(Blood pressure-mmHg, heart rate-beats per minute) of patients, bromage scores, perfusion index (PI) values, discharge time, pain with NRS (numerical rating scale), patient satisfaction will be evaluated ( Numeric output from 1-10).
Hemodynamic variables will be recorded every 2 minutes in the first 20 minutes after spinal anesthesia. hemodynamic variables will be recorded 30 minutes after spinal anesthesia and at the end of the operation.
The perfusion index is the ratio of the blood volume to the pulsatile to non-pulsatile fraction. An increase in the pulsatile fraction that occurs during vasodilation corresponds to a higher PI. Therefore, patients with a higher PI have a higher risk of post-spinal hypotension.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7.5 mg hyperbaric bupivacaine | Active comparator | Other: 7.5 mg hyperbaric bupivacainePatients undergoing spinal anesthesia in the lateral decubitus position with 7.5 mg of hyperbaric bupivacaine will be included. |
| 5 mg hyperbaric bupivacaine | Active comparator | Other: 5 mg hyperbaric bupivacainePatients undergoing spinal anesthesia in the lateral decubitus position with 5 mg of hyperbaric bupivacaine will be included. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ASA(American Society of Anesthesiologists) I-II-III patients
- BMI( body mass index) in the range of 18-40
- over 65 years old hip fracture
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- Left ventricular ejection fraction below 40%
- cardiac arrhythmia
- Patients with peripheral vascular disease
- Failure of spinal anesthesia
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 |
|---|---|---|
| 7.5 mg hyperbaric bupivacaineSpinal anesthesia with 7.5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block | Other | 7.5 mg hyperbaric bupivacaine |
| 5 mg hyperbaric bupivacaineSpinal anesthesia with 5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block | Other | 5 mg hyperbaric bupivacaine |
Primary outcome
hemodynamic variability
Time frame: every 2 minutes for the first 20 minutes after spinal anesthesia
intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery
hemodynamic variability
Time frame: at 30 minutes of spinal anesthesia
intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery
11 secondary outcomes
perfusion index variability
Time frame: every 2 minutes for the first 20 minutes after spinal anesthesia
perfusion index variability
Time frame: at 30 minutes of spinal anesthesia
perfusion index variability
Time frame: at the end of the operation
Sensory Levels
Time frame: 24 hours
ephedrine use
Time frame: 24 hours
fentanyl use
Time frame: 24 hours
bromage scale
Time frame: 24 hours
NRS(numerical rating scale)
Time frame: 2 hours
NRS(numerical rating scale)
Time frame: 8 hours
NRS(numerical rating scale)
Time frame: 16 hours
NRS(numerical rating scale)
Time frame: 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 23 Jul 2024.
- Derived from this study: PubMed 41882562Mafizer M, Kavak Akelma F, Nalbant B. Impact of bupivacaine dose on haemodynamics in elderly hip surgery: a randomized controlled trial. BMC Geriatr. 2026 Mar 26;26(1):630. doi: 10.1186/s12877-026-07374-1.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Spinal
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
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 study testing 7.5 mg hyperbaric bupivacaine and 5 mg hyperbaric bupivacaine in people with Anesthesia, Spinal, run by Ankara City Hospital Bilkent 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 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 23 Jul 2024. 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 variability (time frame: every 2 minutes for the first 20 minutes after spinal anesthesia). The study lists 2 primary outcomes in all. 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 NCT05896631, which also lists 1 linked publication.
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 23 Jul 2024.