A clinical trial to compare Inferior Vena Cava Collapsibility Index (IVCCI) and standard blood pressure monitoring as a better guide to fluid management in post spinal anaesthesia hypotension

Not yet recruiting

• Conditions: Hypotension after induction with spinal anaesthesia

• Registration Number: CTRI/2023/07/055069
• Lead Sponsor: Bharati Hospital and Research Centre

Brief Summary

Spinal anaesthesia is one of the most commonly used methods of anaesthesia for infra umbilical procedures. . While it has advantages such as a rapid onset of action and being relatively cost effective, the most common and immediate complications are hypotension and bradycardia.

A reading of mean arterial pressure (MAP) less than 50 mmHg can be a significant cause of mortality and morbidity. Patients with inadequate volume reserve before the induction of anaesthesia are highly exposed. The identification of latent hypovolemia is therefore crucial. Inferior vena caval ultrasound (IVCUS) is effective to assess fluid responsiveness in critical care patients and has been proposed as a tool for assessing responsiveness in routine patients as well. The primary purpose of my study is to determine the efficacy of IVCCI in predicting this post spinal hypotension and managing the intra-operative fluid doses based on these values. The study will compare standard monitoring procedures i.e. Mean Arterial Pressure (MAP) with the IVCCI to determine which is more effective in predicting hypotension in these  patients. The study will assess the incidence of post spinal hypotension in the standard monitoring group (control) and USG guided measurement group (case) and compare the values obtained along with effectiveness of fluid therapy and fluid responsiveness in both groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-21
• Last Update Posted: 2023-10-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Patients who are undergoing infraumbilical surgery uncder central neuraxial blockade (CNB) 2.
• ASA I and ASA II patients 3.
• Patients with good IVC visualisation.

Exclusion Criteria

• Obstetric patients 2.
• BMI more than 30 3.
• Patients with pre-existing hypovolemia 4.
• Patients contraindicated for central neuraxial blockade.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of hypotension by measuring inferior vena cava collapsibility index(IVCCI) more than 40%	Every 15 minutes for 1 hour after induction with spinal anaesthesia

Secondary Outcome Measures

Name	Time	Method
Comparing the number of vasopressor doses or fluid boluses provided in case & control group to manage intra operative hypotension	For 1 hour post induction with spinal anaesthesia

Trial Locations

Locations (1)

Bharati Hospital and Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Bharati Hospital and Research Centre

🇮🇳Pune, MAHARASHTRA, India

Dr Anindya

Principal investigator

9022733052

anindyaagarwal23@gmail.com