The Effect of Spinal Anesthesia on Hemodynamics

May 31, 2023 updated by: Fatma Kavak Akelma, Ankara City Hospital Bilkent

The Effect of Spinal Anesthesia Methods on Hemodynamics in Geriatric Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 7.5 mg hyperbaric bupivacaine
Patients undergoing spinal anesthesia in the lateral decubitus position with 7.5 mg of hyperbaric bupivacaine will be included.
Spinal anesthesia with 7.5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block
Active Comparator: 5 mg hyperbaric bupivacaine
Patients undergoing spinal anesthesia in the lateral decubitus position with 5 mg of hyperbaric bupivacaine will be included.
Spinal anesthesia with 5 mg hyperbaric bupivacaine after preoperative peng (pericapsular nerve group) block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
every 2 minutes for the first 20 minutes after spinal anesthesia
hemodynamic variability
Time Frame: at 30 minutes of spinal anesthesia
intraoperative hemodynamic variables (BP(blood pressure-mmHg) during hip surgery
at 30 minutes of spinal anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perfusion index variability
Time Frame: every 2 minutes for the first 20 minutes after spinal anesthesia
To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
every 2 minutes for the first 20 minutes after spinal anesthesia
perfusion index variability
Time Frame: at 30 minutes of spinal anesthesia
To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
at 30 minutes of spinal anesthesia
perfusion index variability
Time Frame: at the end of the operation
To correlate between perfusion index and hypotension after spinal anaesthesia in hip surgery
at the end of the operation
Sensory Levels
Time Frame: 24 hours
Sensory levels will be measured every 30 minutes until discharge from PACU(post-anaesthesia care unit)
24 hours
ephedrine use
Time Frame: 24 hours
ephedrine consumption , mg in hip surgery
24 hours
fentanyl use
Time Frame: 24 hours
fentanyl consumption , mcg in hip surgery
24 hours
bromage scale
Time Frame: 24 hours
Bromage Scores every 30 minutes until discharge from PACU(post-anaesthesia care unit).
24 hours
NRS(numerical rating scale)
Time Frame: 2 hours
pain scoring a score of 1 to 10
2 hours
NRS(numerical rating scale)
Time Frame: 8 hours
pain scoring a score of 1 to 10
8 hours
NRS(numerical rating scale)
Time Frame: 16 hours
pain scoring a score of 1 to 10
16 hours
NRS(numerical rating scale)
Time Frame: 24 hours
pain scoring a score of 1 to 10
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 8, 2023

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

September 25, 2023

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 9, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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