NCT05342311

Brief Summary

In this study we will determine the ability of preoperative ultrasonographic evaluation of the right common femoral vein diameter to predict spinal anesthesia-induced hypotension in elderly patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

April 16, 2022

Last Update Submit

January 5, 2024

Conditions

Spinal Anesthesia-induced Hypotension

Outcome Measures

Primary Outcomes (1)

  • The sensitivity of the transverse diameter (mm) value of the right common femoral vein as measured by ultrasound before anesthesia to predict spinal aneshesia-induced hypotension in elderly patients.

    30 minutes after spinal anesthesia

Secondary Outcomes (2)

  • Incidence of spinal anesthesia-induced hypotension in elderly

    30 minutes after spinal anesthesia

  • The sensitivity of the peak velocity of blood flow (mm/s) in the right common femoral vein as measured by ultrasound before anesthesia to predict spinal anesthesia-induced hypotension in elderly patients

    30 minutes after spinal anesthesia

Interventions

preoperative ultrasonographic evaluation of right common femoral vein diameterDIAGNOSTIC_TEST

preoperative ultrasonographic evaluation of right common femoral vein diameter to predict spinal anesthesia-induced hypotension in elderly patients

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 68 consecutive elderly patients, aged \>65 years scheduled for elective surgical operations under spinal anesthesia will be included in the study.

You may qualify if:

  • years of age or more.
  • ASA score I \& II.
  • Patients scheduled for surgeries under spinal anesthesia.

You may not qualify if:

  • Negative consent.
  • pre-existing hypertension
  • Diabetes mellitus or autonomic neuropathy.
  • Emergency operations.
  • Absolute contraindications or failure to perform spinal anesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university hospital

Cairo, Giza Governorate, 202, Egypt

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 16, 2022

First Posted

April 22, 2022

Study Start

June 3, 2022

Primary Completion

January 5, 2024

Study Completion

January 5, 2024

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

EG(1)