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Clinical Trials/NCT05896631
NCT05896631CompletedNot Applicable

The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients

Ankara City Hospital Bilkent1 site in 1 country80 target enrollmentStarted: June 8, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
hemodynamic variability

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts 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

Arms & Interventions

7.5 mg hyperbaric bupivacaine

Active Comparator

Patients undergoing spinal anesthesia in the lateral decubitus position with 7.5 mg of hyperbaric bupivacaine will be included.

Intervention: 7.5 mg hyperbaric bupivacaine (Other)

5 mg hyperbaric bupivacaine

Active Comparator

Patients undergoing spinal anesthesia in the lateral decubitus position with 5 mg of hyperbaric bupivacaine will be included.

Intervention: 5 mg hyperbaric bupivacaine (Other)

Outcomes

Primary Outcomes

hemodynamic variability

Time Frame: at 30 minutes of spinal anesthesia

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

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

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)
  • perfusion index variability(every 2 minutes for the first 20 minutes after spinal anesthesia)
  • perfusion index variability(at 30 minutes of spinal anesthesia)
  • NRS(numerical rating scale)(2 hours)
  • NRS(numerical rating scale)(8 hours)
  • NRS(numerical rating scale)(16 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fatma Kavak Akelma

Anesthesiology and reanimation assistant doktor

Ankara City Hospital Bilkent

Study Sites (1)

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