- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07399093
Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index After Induction of General Anesthesia
Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index for Prediction of Hypotension After Induction of General Anesthesia in Patients Undergoing Craniotomy Surgeries
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Post- anesthesia hypotension is of common occurrence, and it hampers tissue perfusion. The magnitude of hypotension is determined by the preoperative volume status, which varies depending on American Society of Anesthesiologists (ASA) physical status, preoperative comorbidities, preoperative medications, and fasting.
General anesthesia causes significant alterations in hemodynamics, as both inhalational and intravenous anesthetics cause bradycardia, decrease in systemic vascular resistance and vasodilatation, and decrease in myocardial contractility, cardiac output and stroke volume, with the absence of surgical stimulus, making induction of anesthesia is the most crucial period at which hypotension occurs.
Due to different definitions of hypotension and diverse patient populations, the effect of volume preload on prevention of hypotension is still controversial. Many recommendations to identified sonographic determination of inferior vena cava (IVC) collapsibility index (IVCCI) as non-invasive, and easy technique for evaluating volume status. Recent guidelines from the American Society of Echocardiography support the general use of IVCCI in assessing volume status.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Verina F Zaref, MSc
- Phone Number: 00201098858385
- Email: verina.fares@med.asu.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 11591
- Recruiting
- Ain Shams University Hospitals
-
Contact:
- Verina F Bekheet, MSc
- Phone Number: 00201098858385
- Email: verina.fares@med.asu.edu.eg
-
Sub-Investigator:
- Sherif W Sarguios, MD
-
Sub-Investigator:
- Dalia A Mohamed, MD
-
Sub-Investigator:
- Noha M EL-Tobgy, MD
-
Sub-Investigator:
- Mai M Elhefny, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age from 18 to 40 years.
- Both sexes.
- Body Mass Index< 40 kg/m².
- American Society of Anesthesiologists (ASA) physical status I, II.
- Fasted according to the ASA guidelines: 2 hours for clear fluids, 6 hours after light meal, 8 hours after a full meal with high calorie or fat content.
- Scheduled for elective craniotomy surgeries before induction of general anesthesia.
Exclusion Criteria:
- Current or recent pregnancy (within 3 months).
- Pre-existing cardiac disease or hypertension.
- On medications affecting blood pressure [Beta-blockers (BBs) and calcium channel blockers (CCBs)] .
- Refusing to undergo the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Patients scheduled for elective craniotomy surgeries before induction of general anesthesia.
|
Inferior vena cava (IVC) collapsibility index (IVCCI) will be measured. The IVCCI is calculated using the following formula: IVCCI = (maximum IVC diameter - minimum IVC diameter) / maximum IVC diameter * 100 The Inferior vena cava (IVC): Ao index will be derived by taking the ratio of the maximum IVC diameter during expiration and the maximal abdominal aortic diameter during systole. - The caval aorta index (IVC/Ao) is calculated using the following formula: IVC/Ao index = IVC diameter / aortic diameter. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO)
Time Frame: 15 minutes post-induction of general anesthesia.
|
Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO) to predict hypotension will be recorded.
|
15 minutes post-induction of general anesthesia.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Specificity of ultrasound guided Aorto-Caval index (IVC-AO)
Time Frame: 15 minutes post-induction of general anesthesia.
|
Specificity of ultrasound guided Aorto-Caval index (IVC-AO) to predict hypotension will be recorded.
|
15 minutes post-induction of general anesthesia.
|
|
Sensitivity of inferior vena cava (IVC) collapsibility index
Time Frame: 15 minutes post-induction of general anesthesia.
|
Sensitivity of inferior vena cava (IVC) collapsibility index to predict hypotension will be recorded.
|
15 minutes post-induction of general anesthesia.
|
|
Specificity of inferior vena cava (IVC) collapsibility index
Time Frame: 15 minutes post-induction of general anesthesia.
|
Specificity of inferior vena cava (IVC) collapsibility index to predict hypotension will be recorded.
|
15 minutes post-induction of general anesthesia.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FMASU MD08/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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