NCT05650008

Brief Summary

The objective of this study is to assess the effects of intrathecal local anesthetics on left ventricular global longitudinal strain (LVGLS) using transthoracic echocardiography (TTE).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

December 6, 2022

Last Update Submit

November 21, 2023

Conditions

Left Ventricular DysfunctionSpinal Anesthetics Causing Adverse Effects in Therapeutic UseGlobal Cardiac Wall Motion Dysfunction

Keywords

Strain

Outcome Measures

Primary Outcomes (1)

  • Left Ventricular Global Longitudinal Strain

    5 minutes

Secondary Outcomes (1)

  • Left Ventricular Ejection Fraction

    5 minutes

Interventions

Intrathecal local anesthesiaDRUG

Administration of local anesthetic into intrathecal space to achieve surgical anesthesia

Also known as: Spinal anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with no known history of LV dysfunction undergoing elective surgery under spinal anesthesia.

You may qualify if:

  • Adult patients undergoing elective knee and hip replacements under spinal anesthesia

You may not qualify if:

  • Patients who do not wish to consent
  • Patients with contraindications to TTE
  • Patients with reduced left ventricular systolic function as defined by LV ejection fraction \< 50% on pre-operative echocardiography
  • Patients with body mass index greater than 40
  • Non-English-speaking subjects
  • Cognitively impaired adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Ventricular Dysfunction, LeftSprains and Strains

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Anesthesiology and Perioperative Medicine

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 14, 2022

Study Start

February 1, 2023

Primary Completion

October 10, 2023

Study Completion

October 10, 2023

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

US(1)