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CTRI Number  CTRI/2020/10/028612 [Registered on: 26/10/2020] Trial Registered Prospectively
Last Modified On: 29/11/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Use of ultrasonography for avoiding hypotension due to spinal anesthesia 
Scientific Title of Study   “EFFICACY OF PREOPERATIVE ULTRASONOGRAPHIC EVALUATION OF INFERIOR VENACAVA COLLAPSIBILITY INDEX AND AORTOCAVAL INDEX FOR AVERTING SPINAL INDUCED HYPOTENSION: A PROSPECTIVE OBSERVATIONAL STUDY.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjunath B 
Designation  Post graduate 
Affiliation  S Nijalingappa Medical college 
Address  Department of Anaesthesia,S Nijalingappa Medical College Navanagar ,Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  9480013943  
Fax    
Email  manjunath0993@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Archana Endigeri 
Designation  Assistant professor 
Affiliation  S Nijalingappa Medical college 
Address  Department of Anaesthesia,S Nijalingappa Medical College Navanagar ,Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  7406568382  
Fax    
Email  archanaendigeri86@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Archana Endigeri 
Designation  Assistant Professor 
Affiliation  S Nijalingappa Medical college 
Address  Department of Anaesthesia,S Nijalingappa Medical College Navanagar ,Bagalkot

Bagalkot
KARNATAKA
587102
India 
Phone  7406568382  
Fax    
Email  archanaendigeri86@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, H.S.K Hospital, S Nijalingappa Medical College, Navanagar, Bagalkot,Karnataka 587102 
 
Primary Sponsor  
Name  S N Medical College and HSK Hospital 
Address  Department of Anaesthesia, S Nijalingappa Medical College Navanagar, Bagalkot Department of Anaesthesia, S Nijalingappa Medical College Navanagar, Bagalkot 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjunath B  HSK HOSPITAL ,S N Medical College  Department of Anaesthesia, H.S.K. Hospital, SN Medical college Navanagar, Bagalkot, Karnataka Bagalkot KARNATAKA
Bagalkot
KARNATAKA 
09480013943

manjunath0993@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SNMC Institutional Ethics Committee on human subjects, bagalkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M258||Other specified joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA physical status I to II.
2. Age between 18 to 60 years.
3. Patientss undergoing elective surgeries under spinal anaesthesia.
 
 
ExclusionCriteria 
Details  1. Absolute or relative contraindications to spinal anaesthesia
2. Patients on angiotensin converting enzyme inhibitors,
3. Pregnant women
4. Emergency cases
5. BMI more than 30 kg m−2
6. Patients scheduled for unilateral spinal anaesthesia
7. Failure to perform spinal anaesthesia.
8. Patients with a baseline arterial SBP less than 90 mmHg or mean arterial blood pressure (MBP) less than 70 mmHg.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Based on our study, patients prone for spinal hypotension can be identified before anesthesia and can be treated effectively with crystalloids without causing fluid overload and thereby prevent spinal anesthesia induced hypotension and also reduce the requirement of vasoactive agents.  Before starting surgery, at the end of the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
•Perioperative fluid requirement
•Requirement of vasopressors
•Comparative evaluation of IVC collapsibility index and aortocaval index
 
Beginning of the surgery , end of the surgery 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/11/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Spinal anaesthesia is frequently used in daily clinical practice. Post spinal anaesthesia  hypotension (PSAH) is a common side effect with an incidence of 15.3% to 33% that may result in organ hypoperfusion and ischaemic events1,2.The two fundamental factors in the pathogenesis of PSAH are sensory block level at or above T5 and age more than 40 years3.Patients’ susceptibility to intra-operative hypotension can also be influenced by the pre-operative volume status that may differ according to comorbidities, physical status, pre-operative medications and fasting4.

PSAH due to spinal blockade is principally a consequence of diminished systemic vascular resistance after blockade of preganglionic sympathetic fibers. Many attempts have been tried to prevent PSAH, such as intravenous  volume  preload  or  prophylactic vasopressors. However, fluid co-load has been proved to lower the incidence of PSAH and significantly decrease the 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.

Several methodologies have been tried with a specific goal to predict PSAH, including heart rate variability (HRV), passive leg raise test and perfusion index5,6,7.Although some studies found a positive predictive value of HRV with high sensitivity and specificity for PSAH, others concluded that it was not a reliable predictor as it can be influenced by numerous factors such as diabetes mellitus, ischaemic heart disease, antihypertensive medications, anxiety and spontaneous respiration5.

Various parameters have been investigated recently to estimate the pre-operative intravascular volume status. Sonographic determination of inferior vena cava collapsibility index (IVCCI) and IVC to aorta diameter index (IVC : Ao index) has been introduced into clinical practice for the assessment of intravascular volume in many studies and reported to be easy reliable and noninvasive  for evaluating the volume status. So, the aim of this study is to evaluate the efficacy of both pre-operative IVCCI and IVC : Ao index for predicting the occurrence of PSAH.

 
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