- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06814054
Carotid Artery Corrected Flow Time and Inferior Vena Cava Collapsibility Index for Prediction of Hypotension After Induction of General Anesthesia in Geriatric Patients Undergoing Elective Surgery
Study Overview
Status
Conditions
Detailed Description
Following the onset of general anesthesia, hypotension is frequently observed, and intraoperative hypotension is linked to end organ damage following surgery, including cardiac ischemia and severe renal injury. postoperative end-organ damage depends on the duration and magnitude.
The incidence of hypotension after induction of general anesthesia varies and is influenced by the induction agent, patient characteristics, and the definition of hypotension.
Hypotension was defined by a 30% reduction in the SBP or 20% reduction in the MAP from baseline or an absolute SBP of less than 90 mm Hg and MAP of less than 65 mm Hg within 3 minutes after induction of general anesthesia.
Elderly people are more likely to experience hemodynamic fluctuation and hypotension due to the high prevalence of left ventricular diastolic failure, lower vascular reactivity and higher sensitivity to anesthetics. More significantly, older patients can't tolerate hypotension for a long time.
A variety of hemodynamic monitoring techniques have been used to predict post- anesthetic hypotension. Non-invasive cardiometry, ultrasound evaluation of fluid status, and pulse oximetry variables, such as the perfusion index and pulse variability index, were utilized.
Zhang and Critchley demonstrated that preoperative hypovolemia predicted postinduction hypotension as determined by the inferior vena cava (IVC) diameter and IVC collapsibility index.
In many clinical situations, volume-responsive patients have been identified using Doppler-derived metrics such as the peak blood flow peak velocity variation (ðVpeak) and the common carotid artery corrected flow time (cFT).
The carotid artery Doppler measures provide several benefits, including being noninvasive and being technically simple to obtain due to the carotid artery's superficial nature. Since the common carotid artery cFT is unaffected by respiratory attempts, it can also be used to assess a patient's volume responsiveness when they are breathing on their own.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: sameh Ahmed
- Email: samehabdelkhalik1982@gmail.com
Study Contact Backup
- Name: tarek AH Mostafa
- Phone Number: 01003591332
- Email: dr.tarek311@yahoo.com
Study Locations
-
-
El Gharbyia
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Tanta, El Gharbyia, Egypt, 31111
- Recruiting
- Faculty of medicine, Tanta University
-
Contact:
- tarek Mostafa
- Phone Number: 020403332033
- Email: dr.tarek311@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- American Society of Anaesthesiologists Physical Status I to Ⅱ
- receiving general anesthesia for elective surgery
- fasted for at least 6 to 8 hours were recruited in this study
Exclusion Criteria:
• patients who refused to participate in the study
- American Society of Anaesthesiologists Physical Status Ⅲ or Ⅳ
- Patients with a history of peripheral arterial diseases or atherosclerosis
- Patients with body mass index of greater than 30 kg/m2
- Patients with arrhythmia or cardiomyopathy
- Chronic obstructive pulmonary disease (COPD)
- baseline systolic arterial pressure (SAP) ≥ 180 mmHg or < 90mmHg
- Any episode of desaturation or difficult intubation during general anasethia induction
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
GA induced hypotension in geriatrics
Postinduction hypotension will be defined as either
At the end of surgery. |
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the diagnostic efficacy of cFT by Carotid ultrasound and IVC collapsibility index in prediction of hypotension after induction of general anesthesia in geriatric patients
Time Frame: immediate preoperative peroid before the induction of general anesthesia
|
the diagnostic efficacy of cFT by Carotid ultrasound and IVC collapsibility index in prediction of hypotension after induction of general anesthesia in geriatric patients undergoing elective surgery.
|
immediate preoperative peroid before the induction of general anesthesia
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: tarek Mostafa, tanta university, faculty of medicine
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hypotension in geriatrics
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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