- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06078228
Prediction of Hypotension During Induction of General Anesthesia
August 2, 2024 updated by: Ain Shams University
Assessment of Ultrasonographic Carotid Artery Corrected Flow Time and Internal Jugular Vein Collapsibility Index in Prediction of Hypotension During Induction of General Anesthesia
Post induction hypotension is closely related to postoperative complications.
Patients are at high risk of hypotension due to preexisting hypovolemia and the vasodilatory effects of induction agents.
Ultrasonographic measurement of the Carotid artery corrected flow time and internal jugular vein collapsibility index may predict post induction hypotension.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
- Type of Study: Observational Prospective Cohort Design.
- Study Setting and ethical consideration: The approval of the Scientific Research Ethics Committee of the Faculty of Medicine, Ain Shams University will be obtained before starting work on the study. This study will be conducted in operating theatres of Ain Shams University Hospitals. Informed written consents to participate will be obtained from the patients.
- Study Period: One year (October 2023-October 2024)
- Study Population: Adult patient undergoing elective surgeries.
Study Type
Observational
Enrollment (Estimated)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Abbassia
-
Cairo, Abbassia, Egypt, 7154411
- Ain shams university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Adult patient undergoing elective surgeries.
Description
Inclusion Criteria:
1- Patients of American Society of Anesthesiologists (ASA) physical status I to II of both genders.
2- Aged 18-65 years. 3- Elective surgeries under general anesthesia. 4- BMI less than 40.
Exclusion Criteria:
Patients with
- Renal diseases.
- Hepatic diseases.
- ASA scores of 3-4.
- The presence of a left ventricular ejection fraction less than 50%.
- Age under 18 years old.
- Patient refusal.
- Coronary heart disease.
- Cardiac disease including cardiomyopathy and mild to severe valve disease.
- Pulmonary hypertension.
- Peripheral arterial disease.
- Preoperative cervical vascular ultrasound abnormalities including plaque, stenosis and anatomical variation.
- Any previous neck surgery or trauma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the predictive value of the carotid Ftc for prediction of hypotension.
Time Frame: one year
|
to investigate the reliability of preanesthetic ultrasound measurements of the carotid artery FTc and the internal jugular vein collapsibility index in predicting hypotension during the induction of general anesthesia
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marina George, MD candidate, Ain shams university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2023
Primary Completion (Estimated)
August 17, 2024
Study Completion (Estimated)
August 17, 2024
Study Registration Dates
First Submitted
October 5, 2023
First Submitted That Met QC Criteria
October 5, 2023
First Posted (Actual)
October 11, 2023
Study Record Updates
Last Update Posted (Estimated)
August 5, 2024
Last Update Submitted That Met QC Criteria
August 2, 2024
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypotension
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Neuromuscular Agents
- Mydriatics
- Nicotinic Antagonists
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Fentanyl
- Propofol
- Atropine
- Atracurium
Other Study ID Numbers
- FMASU MD205/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.