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Clinical Trials/NCT05896631
NCT05896631
Completed
Not Applicable

The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients

Ankara City Hospital Bilkent1 site in 1 country80 target enrollmentJune 8, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Spinal
Sponsor
Ankara City Hospital Bilkent
Enrollment
80
Locations
1
Primary Endpoint
hemodynamic variability
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
June 8, 2023
End Date
October 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fatma Kavak Akelma

Anesthesiology and reanimation assistant doktor

Ankara City Hospital Bilkent

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

Outcomes

Primary Outcomes

hemodynamic variability

Time Frame: at 30 minutes of spinal anesthesia

intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery

Secondary Outcomes

  • Sensory Levels(24 hours)
  • ephedrine use(24 hours)
  • fentanyl use(24 hours)
  • bromage scale(24 hours)
  • perfusion index variability(at the end of the operation)
  • NRS(numerical rating scale)(24 hours)

Study Sites (1)

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