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
|
|
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
|
|
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. |