NCT07747441

Brief Summary

This prospective observational study aims to investigate the role of the baseline perfusion index (PI) in predicting spinal anesthesia-induced hypotension (SAIH) in ASA I-II patients undergoing day-case knee arthroscopy. Spinal anesthesia is a widely preferred technique for lower extremity surgeries, including knee arthroscopy. However, sympathetic blockade during spinal anesthesia frequently leads to significant hemodynamic instability, particularly hypotension, which can result in adverse perioperative outcomes. While age and baseline blood pressure are traditional risk factors, they often fail to accurately predict the onset of hypotension in healthy populations. The perfusion index (PI), a non-invasive parameter measured via pulse oximetry, reflects peripheral vascular tone and baseline sympathetic activity. An elevated baseline PI indicates baseline vasodilation and a higher susceptibility to sympathectomy, potentially offering an early and non-invasive prediction of SAIH before the hemodynamic collapse occurs. The primary outcome of the study is the incidence of spinal anesthesia-induced hypotension (defined as a mean arterial pressure \< 65 mmHg or a decrease in systolic blood pressure \> 25% from baseline). Secondary outcomes include the onset time of sensory block, and intraoperative ephedrine and fluid requirements.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

July 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

August 12, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2026

14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2026

Last Updated

August 5, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

July 30, 2026

Last Update Submit

August 4, 2026

Conditions

Keywords

Perfusion IndexSpinal AnesthesiaHypotensionKnee Arthroscopy

Outcome Measures

Primary Outcomes (1)

  • Spinal anesthesia-induced hypotension

    Defined as a mean arterial pressure \< 65 mmHg or a decrease in systolic blood pressure \> 25% from baseline

    During the surgery

Secondary Outcomes (2)

  • Investigation of Sensory Block Kinetics

    Periprocedural

  • Vasopressor Consumption

    During the surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with American Society of Anesthesiologists physical status I or II who are scheduled for elective knee arthroscopy under spinal anesthesia at Etlik City Hospital will be consecutively screened for participation.

You may qualify if:

  • Between the ages of 18-65
  • Having an ASA Score of I-II
  • Including data collection of parts that underwent knee arthroscopy

You may not qualify if:

  • Patients under 18 and over 65 years of age
  • Patients with ASA Score III and above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Yenimahalle\Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

İbrahim MD Topcu, MD

CONTACT

Musa Ass. Prof Zengin, Ass. Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 5, 2026

Study Start (Estimated)

August 12, 2026

Primary Completion (Estimated)

December 14, 2026

Study Completion (Estimated)

December 28, 2026

Last Updated

August 5, 2026

Record last verified: 2026-08

Locations