NCT05259124

Brief Summary

In this study, we will test the ability of positional perfusion index variation to predict post-spinal anesthesia 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

January 17, 2022

Last Update Submit

August 23, 2023

Conditions

Spinal Anesthesia Induced Hypotension

Outcome Measures

Primary Outcomes (1)

  • The sensitivity of perfusion index postural change in predicting spinal anesthesia-induced hypotension in elderly patients.

    The sensitivity of incremental change of a measured perfusion index pre and post spinal anesthesia

    30 minutes after spinal anesthesia

Secondary Outcomes (3)

  • incidence of spinal anesthesia induced hypotension in elderly

    30 minutes after spinal anesthesia

  • • The sensitivity of supine perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.

    30 minutes after spinal anesthesia

  • • The sensitivity of sitting perfusion index to predict spinal anesthesia-induced hypotension in elderly patients.

    30 minutes after spinal anesthesia

Interventions

positional perfusion index variationDEVICE

positional perfusion index variation to predict spinal anesthesia-induced hypotension in elderly patients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
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

January 17, 2022

First Posted

February 28, 2022

Study Start

June 3, 2022

Primary Completion

August 23, 2023

Study Completion

August 23, 2023

Last Updated

August 25, 2023

Record last verified: 2023-08

Locations

EG(1)