- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05896631
The Effect of Spinal Anesthesia on Hemodynamics
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Çankaya
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Ankara, Çankaya, Turkey, 06800
- Ankara Bilkent City Hospital
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Contact:
- Milas Mafizer
- Phone Number: +905396204410
- Email: milas.mafizer@gmail.com
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Contact:
- Fatma Akelma
- Phone Number: +905327079113
- Email: fatmakavak@yahoo.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Refusal to participate in the study
- Left ventricular ejection fraction below 40%
- cardiac arrhythmia
- Patients with peripheral vascular disease
- Failure of spinal anesthesia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 7.5 mg hyperbaric bupivacaine
Patients undergoing spinal anesthesia in the lateral decubitus position with 7.5 mg of hyperbaric bupivacaine will be included.
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Spinal anesthesia with 7.5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block
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Active Comparator: 5 mg hyperbaric bupivacaine
Patients undergoing spinal anesthesia in the lateral decubitus position with 5 mg of hyperbaric bupivacaine will be included.
|
Spinal anesthesia with 5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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every 2 minutes for the first 20 minutes after spinal anesthesia
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hemodynamic variability
Time Frame: at 30 minutes of spinal anesthesia
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intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery
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at 30 minutes of spinal anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
perfusion index variability
Time Frame: every 2 minutes for the first 20 minutes after spinal anesthesia
|
To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
|
every 2 minutes for the first 20 minutes after spinal anesthesia
|
perfusion index variability
Time Frame: at 30 minutes of spinal anesthesia
|
To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
|
at 30 minutes of spinal anesthesia
|
perfusion index variability
Time Frame: at the end of the operation
|
To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
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at the end of the operation
|
Sensory Levels
Time Frame: 24 hours
|
Sensory levels will be measured every 30 minutes until discharge from PACU(post-anaesthesia care unit)
|
24 hours
|
ephedrine use
Time Frame: 24 hours
|
ephedrine consumption , mg in hip surgery
|
24 hours
|
fentanyl use
Time Frame: 24 hours
|
fentanyl consumption , mcg in hip surgery
|
24 hours
|
bromage scale
Time Frame: 24 hours
|
Bromage Scores every 30 minutes until discharge from PACU(post-anaesthesia care unit).
|
24 hours
|
NRS(numerical rating scale)
Time Frame: 2 hours
|
pain scoring a score of 1 to 10
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2 hours
|
NRS(numerical rating scale)
Time Frame: 8 hours
|
pain scoring a score of 1 to 10
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8 hours
|
NRS(numerical rating scale)
Time Frame: 16 hours
|
pain scoring a score of 1 to 10
|
16 hours
|
NRS(numerical rating scale)
Time Frame: 24 hours
|
pain scoring a score of 1 to 10
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Geriatrics
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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