The Effect of Spinal Anesthesia on Hemodynamics

NCT ID: NCT05896631

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-08

Study Completion Date

2023-10-01

Brief Summary

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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

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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.

Conditions

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Anesthesia, Spinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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7.5 mg hyperbaric bupivacaine

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

Group Type ACTIVE_COMPARATOR

7.5 mg hyperbaric bupivacaine

Intervention Type OTHER

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

5 mg hyperbaric bupivacaine

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

Group Type ACTIVE_COMPARATOR

5 mg hyperbaric bupivacaine

Intervention Type OTHER

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

Interventions

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7.5 mg hyperbaric bupivacaine

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

Intervention Type OTHER

5 mg hyperbaric bupivacaine

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Fatma Kavak Akelma

Anesthesiology and reanimation assistant doktor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Bilkent City Hospital

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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geriatrics

Identifier Type: -

Identifier Source: org_study_id

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