Prediction of Hypotension During Induction of General Anesthesia

Sponsor

Ain Shams University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06078228

Collaborator

(none)

Enrollment

Location

11.1

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Propfol - Fentanyl- Atracurium

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Sep 24, 2023

Anticipated Primary Completion Date :

Mar 24, 2024

Anticipated Study Completion Date :

Aug 26, 2024

Outcome Measures

Primary Outcome Measures

the predictive value of the carotid Ftc for prediction of hypotension. [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University	Cairo	Abbassia	Egypt	7154411

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator: Marina George, MD candidate, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ain Shams University

ClinicalTrials.gov Identifier:

NCT06078228

Other Study ID Numbers:

FMASU MD205/2023

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 17, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 17, 2023