Peripheral Perfusion Index as a Predictor of Post-spinal... | NCT07279805

Studies
Peripheral Perfusion Index as a Predictor of Post-spinal Hypotension in Patients Undergoing Lower Limb Surgeries

NCT07279805

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Dec 12, 2025Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Post Spinal Anaesthesia Hypotension

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 9, 2024Actual

Primary Completion Date

Mar 9, 2025Actual

Completion Date

Mar 9, 2025Actual

First Submitted Date

Dec 1, 2025

First Submission Date that Met QC Criteria

Dec 1, 2025

First Posted Date

Dec 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2025

Last Update Posted Date

Dec 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This prospective observational study was carried out on a sample of 40 patients over a period of 6 months to asses the peripheral perfusion index as a Predictor for post spinal hypotension in patient undergoing lower limp surgeries.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the ability of baseline peripheral perfusion index to predict post spinal hypotension spinal anesthesia-induced hypotension in patients undergoing lower limb surgeries	Assess the ability of baseline peripheral perfusion index to predict post spinal hypotension	during the operation time.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients aging between 21-40 years of both sexes with average weight of 60-80 kg, and average height of 160-180.
- Patients undergoing Elective Lower limb Surgeries under successful spinal anesthesia (duration of surgery 45-120 minutes).
- ASA physical status classes I - II.

Exclusion Criteria:

Patient's refusal of procedure or participation in the study.
- ASA classes III or above. Coagulopathy and bleeding disorders.
- Body mass index >40kg/m2
- Contraindications to spinal anesthesia.
- Hypersensitivity to the study medications.
- Patients receiving vasoactive drugs.
- Patients undergoing emergency surgery.
- Duration more than 2hours.
- Major bleeding.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

All patients undergoing elective lower limb surgeries at El-demerdash Hospital of Surgery during the study period. Surgeries include Anterior/Posterior curciate ligament repair,knee arthroscopy,Hip and Knee replacement,tendon repair and varicose veins ligation.

Sampling Method

Probability Sample