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The Effect of Spinal Anesthesia on Hemodynamics

The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05896631
Enrollment
80
Registered
2023-06-09
Start date
2023-06-08
Completion date
2023-10-01
Last updated
2024-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Spinal

Keywords

hemodynamic management, spinal anesthesia, geriatric anesthesia

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.

Interventions

OTHER7.5 mg hyperbaric bupivacaine

Spinal anesthesia with 7.5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block

OTHER5 mg hyperbaric bupivacaine

Spinal anesthesia with 5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
hemodynamic variabilityevery 2 minutes for the first 20 minutes after spinal anesthesiaintraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery

Secondary

MeasureTime frameDescription
Sensory Levels24 hoursSensory levels will be measured every 30 minutes until discharge from PACU(post-anaesthesia care unit)
ephedrine use24 hoursephedrine consumption , mg in hip surgery
perfusion index variabilityevery 2 minutes for the first 20 minutes after spinal anesthesiaTo correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
bromage scale24 hoursBromage Scores every 30 minutes until discharge from PACU(post-anaesthesia care unit).
NRS(numerical rating scale)2 hourspain scoring a score of 1 to 10
fentanyl use24 hoursfentanyl consumption , mcg in hip surgery

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026