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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04780139
Other study ID # FMASU R 25/2020/2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date July 21, 2021

Study information

Verified date July 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the efficacy of internal jugular cross sectional area for predicting the occurrence of PSAH.


Description:

The aim of this study is to evaluate the efficacy of internal jugular cross sectional area for predicting the occurrence of PSAH. Spinal anaesthesia is frequently used in daily clinical practice. Postspinal anaesthesia hypotension (PSAH) is a common side effect with an incidence of 15.3 to 33% that may result in organ hypoperfusion and ischaemic events. Patients' susceptibility to intraoperative hypotension can be influenced by the sensory block level, age, preoperative volume status , physical status, pre-operative medications and fasting. PSAH due to spinal blockade is principally a consequence of diminished systemic vascular resistance after blockade of preganglionic sympathetic fibres. Many attempts have been tried to prevent PSAH, such as intravenous volume preload or prophylactic vasopressors. However, fluid infusion has been proved to lower the incidence of PSAH and significantly decrease vasopressor requirements. At the same time, empirical volume loading carries the potential of volume overload, particularly in patients with cardiac disease. Consequently, the search for predictors of PSAH is becoming mandatory to avoid blind volume loading and reserve it only for patients who are expected to develop PSAH. . .


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date July 21, 2021
Est. primary completion date July 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - patients more than 40 years of age. - American Society of Anesthesiologists' (ASA) physical status 1 or 2. - scheduled for elective surgery under spinal anaesthesia in the supine position. Exclusion Criteria: - BMI more than 35 kg m2. - taking angiotensin converting enzyme inhibitors. - pregnant women. - emergency cases. - absolute or relative contraindications to spinal anaesthesia. - Also, patients with a baseline arterial systolic blood pressure less than 90 mmHg or mean arterial blood pressure (MBP) less than 70 mmHg will be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area
Measuring the internal jugular vein cross section area and relate this to the incidence of hypotension after spinal anesthesia.

Locations

Country Name City State
Egypt Ain Shams University hospital Cairo ???????

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Predictive value of internal jugular vein (IJV) cross sectional area. The primary outcome is to evaluate the predictive value of internal jugular diameter cross sectional area for detecting PSAH 30 minutes