Prediction of Hypotension after Spinal Anaesthesia by using ultrasound: an Observational Study

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2018/05/013662
• Lead Sponsor: All India Institute Of Medical SciencesJodhpur

Brief Summary

Hypotension is commonly seen in patients where spinal anaesthesia is used for surgery, especially if the patient is hypovolaemic or fluid deficit. Ultrasound is currently being used in ICU for assessment of IVC diameter in patients with intravascular fluid deficit and in state of shock. We aim to measure the predicting value of inferior vena cava collapsibility index (IVC-CI) to correctly assess the intravascular volume status of patients belonging to American Society of Anesthesiologists (ASA) physical status grade I and II aged between 18 to 75 years undergoing surgery following spinal anaesthesia. Patients will be divided into two groups by calculating the IVC collapsibility index preoperatively as IVC compressible and IVC non compressible. Then intraoperative vitals will be monitored at fixed time interval following spinal anaesthesia using 0.25mg/kg 0.5% bupivacaine (heavy) and 25mcg fentanyl at L3-L4 level with 25/27 G spinal needle and significant hypotension (≤30% fall from baseline blood pressure) will be treated with fluids and vasopressors. At the end of the study, the occurrence and magnitude of hypotension in all these groups will be correlated with preoperative IVC-CI to assess its predicting value.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-05
• Study Completion: 2019-11-10
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

patients belonging to American Society of Anaesthesiologists (ASA) physical status grade I and II, aged between 18 to 75 years, scheduled to undergo surgery in spinal anaesthesia will be enrolled.

Exclusion Criteria

• 1.Patient’s refusal to participate 2.Preexisting skin infection at spinal site 3.Any spinal deformity 4.History of previous spine surgery or fracture at block level 5.Coagulation Disorder 6.Presence of chest crepitations 7.Presence of congestive cardiac failure and fixed cardiac output diseases 8.Preoperative hypotension (Mean arterial blood pressure < 50 mmHg), preoperative bradycardia (Heart rate < 45 beats/min) and preoperative dysrhythmia.
• 9.Preoperative uncontrolled hypertension (≥ 180/110) 10.History of psychiatric illness and preexisting neurological deficits 11.Patient with obesity BMI >30 kg /m2 12.Pregnant patients with gestational age more than 12 weeks 13.Known allergy to study drugs 14.Patient with WBC count more than 11000 15.History of previous diaphragmatic surgery 16.Intraabdominal compartment syndrome or Intraabdominal hypertension (increased Intraabdominal pressure >12 mm of Hg) 17.Congenital anomaly of inferior vena cava.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of hypotension after spinal anaesthesia in IVC compressible patients	30 minutes after spinal anaesthesia

Secondary Outcome Measures

Name	Time	Method
1.The relation of duration and magnitude of hypotension with collapsibility index	2. Ease of visualisation of hepatic vein and IVC.

Trial Locations

Locations (1)

AIIMS JODHPUR; 🇮🇳 Jodhpur, RAJASTHAN, India

AIIMS JODHPUR

🇮🇳Jodhpur, RAJASTHAN, India

Dr SHAYAK ROY

Principal investigator

7001275351

shayakroy@gmail.com