NCT07000188

Brief Summary

Spinal induced hypotension is common complication in geriatric group of patient with percentage up to 73% among these group\]. the most common causes that enhance occurrence of post spinal anesthesia induced hypotension among elderly are poor physical condition , chronic systemic diseases , medications and long fasting time, intraoperative hypotension if severe or prolonged is associated with hazardous complication such as myocardial infarction , stroke, renal failure and perioperative mortality ,so accurate assessment of intravascular volume before induction of anesthesia is necessary to limit these hazards. Various studies had reported that ultrasonographic measurements of inferior vena cava collapsibility index is a good predictor for reflexing the intravascular volume status\[5\]\[6\] , this is non invasive , on the other hand IVC is not easily feasible in obese and pregnant women. Some studies compared the difference between IVC and IJV as predictor marker for fluid responsiveness and reported that right internal jugular vein distensibility appears to be a surrogate marker for inferior vena cava vein distensibility for evaluating fluid responsiveness. Almost great percentage of anesthesiologist easily use IJV ultrasonography for catheterization and it is easily feasible in almost all patients, recent studies documented that noninvasive ultrasonographic measurements of internal jagular vein diameter has a role in assessment of intravascular volume status in spontaneously and mechanically breathing patients, Passive leg raising has been shown to be useful in assessing intravascular volume depletion or fluid responsiveness , some studies compared IJV changing in diameter for supine and trendelenburg positions, there is a similar change in IJV diameter will occur with passive leg raising positions , trendelenburg position may be disadvantageous as it impair gas function and cardiac function especially in elderly and obese patients , on the other hand passive leg raising is simpler and more comfortable to the elderly. Finally preoperative detection of decreased intravascular volume is crucial in elderly patients, so we hypothesized that preoperative ultrasonographic evaluation of the internal jagular vein measurements may be a reliable tool for estimating intravascular volume and prediction of post spinal hypotension in elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

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

First Submitted

Initial submission to the registry

May 23, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2026

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2026

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

May 23, 2025

Last Update Submit

March 8, 2026

Conditions

Keywords

spinal anesthesiaelderlyhypotensionultrasoundpassive leg raisingIJV

Outcome Measures

Primary Outcomes (1)

  • • The accuracy of ultrasonographic changes in IJV area with positions (supine and PLR) in predicting spinal hypotension in geriatric patients.

    time needed to spinal anesthesia related hypotension occurs which arround 20 to 30 minutes

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

elderly patients equal or more than 65 years old

You may qualify if:

  • Age \> 65 years old.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I, II , III.
  • Elective surgeries Under spinal anesthesia in the supine position.

You may not qualify if:

  • Body Mass Index (BMI) more than 35 kg/m2.
  • Uncontrolled hypertension.
  • Ejection fraction less than 40%
  • Emergency cases.
  • Absolute or relative contraindications to spinal anesthesia.
  • Patients with a baseline arterial systolic blood pressure (SBP) less than 90 mmHg or mean arterial blood pressure (MBP) less than 65 mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia at cairo university hospital.

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 2, 2025

Study Start

July 10, 2025

Primary Completion

February 20, 2026

Study Completion

March 3, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations