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The Effect of Spinal Anesthesia on Hemodynamics

A

Ankara City Hospital

Status

Completed

Conditions

Anesthesia, Spinal

Treatments

Other: 7.5 mg hyperbaric bupivacaine
Other: 5 mg hyperbaric bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT05896631
geriatrics

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

7.5 mg hyperbaric bupivacaine
Active Comparator group
Description:
Patients undergoing spinal anesthesia in the lateral decubitus position with 7.5 mg of hyperbaric bupivacaine will be included.
Treatment:
Other: 7.5 mg hyperbaric bupivacaine
5 mg hyperbaric bupivacaine
Active Comparator group
Description:
Patients undergoing spinal anesthesia in the lateral decubitus position with 5 mg of hyperbaric bupivacaine will be included.
Treatment:
Other: 5 mg hyperbaric bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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