NCT07279805

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
Last Updated

December 12, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

December 1, 2025

Last Update Submit

December 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams University

Cairo, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

September 9, 2024

Primary Completion

March 9, 2025

Study Completion

March 9, 2025

Last Updated

December 12, 2025

Record last verified: 2025-08

Locations