Assessment of Ultrasonographic Measurement of Inferior Vena Cava Collapsibility Index in Prediction of Hypertension Associated With Tourniquet Release in Total Knee Replacement Surgeries Under Spinal Anesthesia

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076929
Collaborator
(none)
60
Enrollment
1
Location
6.1
Anticipated Duration (Months)
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Administration of intravascular fluids is one of the methods to prevent SA-induced hypotension, but empirical intraoperative volume repletion carries the risk of fluid overload during elective surgery. Over fluid resuscitation is associated with organ dysfunction and higher mortality rate , thus, to avoid ineffective or even harmful intravascular volume expansion, it is important to have tools to predict hypotension and fluid responsiveness.

Condition or DiseaseIntervention/TreatmentPhase
  • Diagnostic Test: ultrasound

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Ultrasonographic Measurement of Inferior Vena Cava Collapsibility Index in Prediction of Hypertension Associated With Tourniquet Release in Total Knee Replacement Surgeries Under Spinal Anesthesia
Actual Study Start Date :
May 28, 2021
Anticipated Primary Completion Date :
Nov 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Outcome Measures

Primary Outcome Measures

  1. mean arterial blood pressure [15 minutes after tourniquet release]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • ASA grade I, II, III

  • Age 18 -65 yrs

  • Spinal Anesthesia

Exclusion Criteria:
  • Patient refusal

  • Patient having contraindication of Spinal Anesthesia (infection at the site of injection, spine deformity, coagulation disorders ) .

  • Known cardiac, renal, neurological, metabolic, endocrine, psychiatric, respiratory disease.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Ain Shams UniversityCairoEgypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mona Ammar, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05076929
Other Study ID Numbers:
  • MS 292/ 2021
First Posted:
Oct 13, 2021
Last Update Posted:
Oct 13, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021