| CTRI Number |
CTRI/2018/02/011910 [Registered on: 15/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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Evaluation using Ultrasonography for guiding fluid administration in patients undergoing Spinal Anaesthesia |
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Scientific Title of Study
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Evaluation of Inferior Vena Cava Diameter and Inferior Vena Cava Collapsibility Index using Ultrasonography for guiding fluid administration in patients undergoing Spinal Anaesthesia for elective infraumblical surgeries |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
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| Name |
Kiran S |
| Designation |
Associate Professor |
| Affiliation |
INHS Asvini |
| Address |
Dept of Anaesthesia, INHS Asvini,
Colaba, Mumbai
Mumbai
MAHARASHTRA
400005
India |
| Phone |
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| Fax |
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| Email |
drkirans@yahoo.com |
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Details of Contact Person
Public Query
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| Name |
Kiran S |
| Designation |
Assoc Professor |
| Affiliation |
INHS Asvini |
| Address |
Dept of Anaesthesia, INHS Asvini,
Colaba, Mumbai
Mumbai
MAHARASHTRA
400005
India |
| Phone |
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| Fax |
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| Email |
drkirans@yahoo.com |
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Source of Monetary or Material Support
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| INHS Asvini, Colaba, Mumbai - 400005 |
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Primary Sponsor
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| Name |
INHS Asvini |
| Address |
Dept of Anaesthesia,
INHS Asvini, Colaba, Mumbai - 400005 |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shatabdi Chakraborty |
INHS Asvini |
Dept of Anaesthesiology, Operation Theatre, 2nd Floor,
Mumbai
MAHARASHTRA |
09619765043
diyamailme@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, INHS Asvini, Mumbai |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, Patients undergoing spinal anaesthesia for elective infraumblical surgeries, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Group A |
To prevent hypotension after spinal anesthesia, the patient is preloaded with crystalloid (Ringers Lactate) 15 ml/kg prior to and until the beginning of the spinal anesthesia. After spinal anesthesia, crystalloids are administered based on standard calculated maintenance rates. In the event of significant hypotension in spite of fluid administration, judicious pharmacological intervention with the vasopressor, ephedrine, would be administered based on clinical judgment to keep Systolic Blood Pressure more than 90 mm Hg |
| Intervention |
Group B |
A baseline trans-abdominal Ultrasonography is performed prior to spinal anesthesia to measure the IVC Diameter (IVC Dmax) and IVC Collapsibility Index (IVC–CI). The patient is deemed as adequate or depleted volume status, based on predetermined parameters of IVC Dmax and IVC - CI. The patient will be preloaded with crystalloid (Ringers Lactate) 15 ml/kg as a standard of care similar to Group A. After preloading for over 10 minutes, IVC Dmax and IVC-CI are recorded. If volume status is found to be depleted, the patient is given a bolus of 500 ml Ringers Lactate over 10 minutes and IVC Dmax and IVC-CI are re-assessed. This assessment will be done every 10 minutes. Spinal anesthesia will be administered only after the patient is deemed fluid adequate. IVC Dmax and IVC-CI will be recorded at 10, 20 and 30 minutes after spinal anesthesia. If volume status is found to be depleted again after spinal anesthesia, the patient is given a bolus of 500 ml Ringer’s Lactate over 10 minutes and IVC Dmax and IVC-CI are reassessed along with non-invasive blood pressure (NIBP) monitoring. In the event of significant hypotension in spite of fluid administration, judicious pharmacological intervention with the vasopressor, ephedrine, would be administered based on clinical judgment to keep Systolic Blood Pressure more than 90 mm Hg. |
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Inclusion Criteria
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| Age From |
21.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Ages 21-59 yrs
2. Informed consent given
2. ASA I and II
3. Both male and female
4. Spontaneously breathing patient
5. Undergoing elective surgery below umbilicus under spinal anaesthesia |
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| ExclusionCriteria |
| Details |
1. Refusal by patient
2. ASA III and greater
3. Pre-procedural hypotension
4. Coagulopathies
5. Hypertension on medication
6. Coronary artery disease
7. Significant respiratory disease
8. Thromboembolic disorders
9. Arrythmias
10. Heart failure
11. Chronic kidney disease
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| Evaluate the use of IVC diameter and IVC collapsibility index using bedside ultrasonography (USG) to assess volume status for guiding fluid administration in patients undergoing elective infraumblical surgeries under spinal anaesthesia |
At 10, 20 and 30 minutes after Spinal Anaesthesia |
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Secondary Outcome
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| Outcome |
TimePoints |
| Assess the difference in quantity of fluid and amount of vasoactive drugs required for correction of the significant hypotension in patients after spinal anaesthesia with use of USG as compared to empirical therapy |
First 30 minutes after spinal anaesthesia |
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Target Sample Size
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Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
01/02/2016 |
| Date of Study Completion (India) |
22/01/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
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Estimated Duration of Trial
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Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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None Yet |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Data will be analysed to evaluate the efficacy of IVC
diameter and IVC collapsibility index as a noninvasive measure of the volume
status of patients and its usefulness, if any, in preventing significant
hypotension in patients undergoing elective surgery under spinal anaesthesia |