NCT04486612

Brief Summary

Hypotension after spinal anesthesia is associated with significant perioperative morbidity and mortality, especially in hypovolemic patients. Ultrasonographic measurement of internal jugular vein (IJV) has been recently shown as effective in predicting the intravascular volume status. The aim was to investigate the reliability of preanesthetic ultrasound measurements of IJV in predicting hypotension after spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

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

Study Start

First participant enrolled

January 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2020

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

July 22, 2020

Last Update Submit

February 1, 2021

Conditions

Spinal Anesthetics Causing Adverse Effects in Therapeutic UseHypotension Postprocedural

Keywords

spinal anesthesiainternal jugular veinhypotensionultrasonography

Outcome Measures

Primary Outcomes (1)

  • The association between sonographic measurements and postspinal hypotension

    The aim of the study is to evaluate the association between sonographic measurements and postinduction hypotension.

    first 30 minute

Study Arms (2)

hypotension

Other: spinal anesthesia

non-hypotension

Other: spinal anesthesia

Interventions

spinal anesthesiaOTHER

prospective observational study

hypotensionnon-hypotension

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients between the ages of 18-65

You may qualify if:

  • Patients between the ages of 18-65 Patients who read and accept the consent form of the study Patients undergoing elective surgery under spinal anesthesia

You may not qualify if:

  • under 18 years old, ASA scores 3-4, presence of any significant hepatic, renal, cardiavasculary, or respiratory disease, having left ventricular ejection fraction less than 40%, and allergy to study medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Osmangazi Univercity

Eskişehir, 26040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • yeliz kılıç, Ass. Prof

    Eskişehir Osmangazi Univercity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 24, 2020

Study Start

January 1, 2020

Primary Completion

September 24, 2020

Study Completion

September 24, 2020

Last Updated

February 3, 2021

Record last verified: 2021-02

Locations

TU(1)