The Effect of Spinal Anesthesia on Hemodynamics

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients

Conditions
-----------------
Anesthesia, Spinal

Intervention / Treatment
-----------------
* Other: 7.5 mg hyperbaric bupivacaine
* Other: 5 mg hyperbaric bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 7.5 mg hyperbaric bupivacaine<br>Patients undergoing spinal anesthesia in the lateral decubitus position with 7.5 mg of hyperbaric bupivacaine will be included. | Other: 7.5 mg hyperbaric bupivacaine<br>* Spinal anesthesia with 7.5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block<br>|
| Active Comparator: 5 mg hyperbaric bupivacaine<br>Patients undergoing spinal anesthesia in the lateral decubitus position with 5 mg of hyperbaric bupivacaine will be included. | Other: 5 mg hyperbaric bupivacaine<br>* Spinal anesthesia with 5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic variability | intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery | every 2 minutes for the first 20 minutes after spinal anesthesia | 
| hemodynamic variability | intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery | at 30 minutes of spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perfusion index variability | 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 | To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery | at 30 minutes of spinal anesthesia | 
| perfusion index variability | To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery | at the end of the operation | 
| Sensory Levels | Sensory levels will be measured every 30 minutes until discharge from PACU(post-anaesthesia care unit) | 24 hours | 
| ephedrine use | ephedrine consumption , mg in hip surgery | 24 hours | 
| fentanyl use | fentanyl consumption , mcg in hip surgery | 24 hours | 
| bromage scale | Bromage Scores every 30 minutes until discharge from PACU(post-anaesthesia care unit). | 24 hours | 
| NRS(numerical rating scale) | pain scoring a score of 1 to 10 | 2 hours | 
| NRS(numerical rating scale) | pain scoring a score of 1 to 10 | 8 hours | 
| NRS(numerical rating scale) | pain scoring a score of 1 to 10 | 16 hours | 
| NRS(numerical rating scale) | pain scoring a score of 1 to 10 | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodynamic management, spinal anesthesia, geriatric anesthesia