| CTRI Number |
CTRI/2019/04/018429 [Registered on: 05/04/2019] Trial Registered Prospectively |
| Last Modified On: |
21/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of coloading efficacy of Ringers Lactate,Gelatin and Starch Solution in preventing hypotension following spinal anaesthesia |
|
Scientific Title of Study
|
A comparative study of coloading efficacy of Ringers Lactate, 4% Balanced Succinyalted Gelatin Solution and 6% Hydroxyethyl Starch Solution in preventing hypotension following spinal anaesthesia |
| Trial Acronym |
CRLGSHSA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandramani |
| Designation |
Junior Resident |
| Affiliation |
IMS, Banaras Hindu University |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9669288060 |
| Fax |
|
| Email |
chandramani25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandramani |
| Designation |
Junior Resident |
| Affiliation |
IMS, Banaras Hindu University |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9669288060 |
| Fax |
|
| Email |
chandramani25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chandramani |
| Designation |
Junior Resident |
| Affiliation |
IMS, Banaras Hindu University |
| Address |
Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9669288060 |
| Fax |
|
| Email |
chandramani25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Insititute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh |
| Address |
Department Of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh |
| Type of Sponsor |
Government 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 |
| Chandramani |
Department of Anaesthesiology, Institute of Medical Sciences, Sir Sundar lal Hospital, BHU, Varanasi |
Institute of Medical Sciences, Banaras Hindu University,
Varanasi
UTTAR PRADESH |
9669288060
chandramani25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Faculty of Medicine, Insititute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (2) ICD-10 Condition: S720||Fracture of head and neck of femur, (3) ICD-10 Condition: S822||Fracture of shaft of tibia, (4) ICD-10 Condition: S722||Subtrochanteric fracture of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Using Gealtin4% solution and Hydroxyethyl Starch Solution in Spianl Anesthesia |
Efficacy of 4% Balanced Succinyalted Gelatin Solution and 6% Hydroxyethyl Starch Solution in preventing hypotension following spinal anaesthesia. |
| Comparator Agent |
Using Ringer Lactate solution in spinal anaesthesia |
Efficacy of Ringer Lactate Solution in preventing hypotension following spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective Surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient allergic to any of colloids
Patient with renal disease
Patient Refusal
Bleeding Diathesis
Hemodynamically Unstable patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ringer Lactate is better overall including cost effectivenss than Gelatin and Hydroxyethyl Starch in prevention of post spinal hypotension |
Base Line
Post Spinal
1 Minute
3 Minutes
5 Minutes
10 Minutes
15 Minutes
30 Minutes
45 Minutes
60 Minutes
90 Minutes
3 Hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ringer lactate is better overall including easy availibility and cost effective |
Base Line
Post Spinal
1 Minute
3 Minutes
5 Minutes
10 Minutes
15 Minutes
30 Minutes
45 Minutes
60 Minutes
90 Minutes
3 Hours
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2019 |
| Date of Study Completion (India) |
28/06/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This randomized prospective study will be carried out on 90 adult
patients of ASA physical status I and II, scheduled for elective surgeries
under spinal anaesthesia. After the approval by the institutional Ethical
Committee, written informed consent will be obtained from all the patients
before being included in the study. They will be randomly allocated to
following groups of 30 each:
• Group R: Patients will receive Ringer’s Lactate solution as
coloading fluid.
• Group G: Patients
will receive 4% Balanced Succinylated Gelatin solution as coloading fluid.
• Group H: Patients
will receive 6% Hydroxyethyl Starch solution as coloading fluid.
Patients in group-R
will receive Ringer’s lactate, patients in group-G will receive 4%
Balanced Succinylated Gelatin solution and group-H will receive 6%
Hydroxyethyl Starch solution. All these solutions will be infused over a
period of 20 minutes along with performance of subarachnoid block. After
coloading, all patients will receive Ringer’s Lactate solution for fluid
maintenance. Baseline parameters and post spinal parameters will be recorded
using an electronic patient monitoring device, and entered into each patients
proforma sheet. Following spinal anaesthesia mean arterial pressure will be
recorded at following intervals -1,3,5,10,15,30,45,60,90 minutes and 3 hours
after spinal anaesthesia.
The study will end at
the end of 1 month after all data has been obtained. |