Clinical trial NCT05896631: The Effect of Spinal Anesthesia on Hemodynamics
Official title: The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Spinal
Keywords: hemodynamic management
spinal anesthesia
geriatric anesthesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: hemodynamic variability
timeFrame: every 2 minutes for the first 20 minutes after spinal anesthesia
measure: hemodynamic variability
timeFrame: at 30 minutes of spinal anesthesia
Secondary outcomes:
measure: perfusion index variability
timeFrame: every 2 minutes for the first 20 minutes after spinal anesthesia
measure: perfusion index variability
timeFrame: at 30 minutes of spinal anesthesia
measure: perfusion index variability
timeFrame: at the end of the operation
measure: Sensory Levels
timeFrame: 24 hours
measure: ephedrine use
timeFrame: 24 hours
measure: fentanyl use
timeFrame: 24 hours
measure: bromage scale
timeFrame: 24 hours
measure: NRS(numerical rating scale)
timeFrame: 2 hours
measure: NRS(numerical rating scale)
timeFrame: 8 hours
measure: NRS(numerical rating scale)
timeFrame: 16 hours
measure: NRS(numerical rating scale)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Çankaya
Study officials:
References: