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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06078228
Other study ID # FMASU MD205/2023
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 24, 2023
Est. completion date August 26, 2024

Study information

Verified date September 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. Ultrasonographic measurement of the Carotid artery corrected flow time and internal jugular vein collapsibility index may predict post induction hypotension.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 70
Est. completion date August 26, 2024
Est. primary completion date June 24, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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 1. Renal diseases. 2. Hepatic diseases. 3. ASA scores of 3-4. 4. The presence of a left ventricular ejection fraction less than 50%. 5. Age under 18 years old. 6. Patient refusal. 7. Coronary heart disease. 8. Cardiac disease including cardiomyopathy and mild to severe valve disease. 9. Pulmonary hypertension. 10. Peripheral arterial disease. 11. Preoperative cervical vascular ultrasound abnormalities including plaque, stenosis and anatomical variation. 12. Any previous neck surgery or trauma.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Propfol - Fentanyl- Atracurium
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.

Locations

Country Name City State
Egypt Ain Shams University Cairo Abbassia

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 one year
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