AnesthesiaNCT06078228
Prediction of Hypotension During Induction of General Anesthesia
An observational study of Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Propofol - Fentanyl- Atracurium
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Sep 2023to 17 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patient undergoing elective surgeries.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Propofol - Fentanyl- Atracurium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol - Fentanyl- AtracuriumDrug
Also called Atropine
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
the predictive value of the carotid Ftc for prediction of hypotension.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start24 Sep 2023
- Primary completion17 Aug 2024 (estimated)
- Study completion17 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marina George, MD candidate, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078228
- Sponsor's protocol ID
- FMASU MD205/2023
- Status last verified
- Sep 2023
- First submitted
- 5 Oct 2023
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Ultrasonographic Carotid Artery Corrected Flow Time and Internal Jugular Vein Collapsibility Index in Prediction of Hypotension During Induction of General Anesthesia
- ClinicalTrials.gov ID
- NCT06078228
- Acronym / sponsor ID
- FMASU MD205/2023
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- 17 Aug 2024 (estimated)
- Study completion
- 17 Aug 2024 (estimated)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient undergoing elective surgeries.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- Patients with
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol - Fentanyl- AtracuriumAlso: Atropineinvestigate 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. | Drug | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina George, MD candidate principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the predictive value of the carotid Ftc for prediction of hypotension. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.