The Ability of Perfusion Index and Positional Perfusion Index Variation to Predict Spinal Anesthesia-induced Hypotension in Elderly Patients

• Sponsor: Cairo University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05259124
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Anticipated Duration (Months): 8.9
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spinal Anesthesia Induced Hypotension	Device: positional perfusion index variation

Study Design

• Study Type: Observational
• Anticipated Enrollment: 68 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: The Ability of Perfusion Index and Positional Perfusion Index Variation to Predict Spinal Anesthesia-induced Hypotension in Elderly Patients: A Prospective Observational Study
• Actual Study Start Date: Jun 3, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Outcome Measures

Primary Outcome Measures

1. The sensitivity of perfusion index postural change in predicting spinal anesthesia-induced hypotension in elderly patients. [30 minutes after spinal anesthesia]

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

Secondary Outcome Measures

1. incidence of spinal anesthesia induced hypotension in elderly [30 minutes after spinal anesthesia]

   incidence of spinal anesthesia induced hypotension in elderly

2. • The sensitivity of supine perfusion index to predict spinal anesthesia-induced hypotension in elderly patients. [30 minutes after spinal anesthesia]

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

3. • The sensitivity of sitting 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 65 years of age or more.

• ASA score I & II.

• Patients scheduled for surgeries under spinal anesthesia.

Exclusion Criteria:

• Negative consent.

• pre-existing hypertension

• Diabetes mellitus or autonomic neuropathy.

• Emergency operations.

• Absolute contraindications or failure to perform spinal anesthesia.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university hospital	Cairo	Giza	Egypt	202

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amr Ahmed Mahmoud AbdelKader, principal investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT05259124
• Other Study ID Numbers: N-122-2021
• First Posted: Feb 28, 2022
• Last Update Posted: Jun 7, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypotension

Study Results

No Results Posted as of Jun 7, 2022