| CTRI Number |
CTRI/2023/09/057477 [Registered on: 12/09/2023] Trial Registered Prospectively |
| Last Modified On: |
04/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Blood sugar levels during lower limb surgery under subarachnoid block |
|
Scientific Title of Study
|
Comparing effect of 6% hydroxyethyl starch-450 Versus ringer lactate on Blood sugar levels during lower limb surgery under subarachnoid block: A prospective randomised interventional study in Department of Anaesthesia, SMS medical college, jaipur
|
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHRIPHAL MEENA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITALS |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY DHANVANTRI COMPLEX, SMS MEDICAL COLLEGE JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928350391 |
| Fax |
|
| Email |
dr.shriphal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHRIPHAL MEENA |
| Designation |
SENIOR PROFESSOR |
| Affiliation |
SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITALS |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY DHANVANTRI COMPLEX, SMS MEDICAL COLLEGE JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928350391 |
| Fax |
|
| Email |
dr.shriphal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SIDHARTH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITALS |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY DHANVANTRI COMPLEX, SMS MEDICAL COLLEGE JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
8950531827 |
| Fax |
|
| Email |
skapril318@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, SMS Medical College and attached Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
SMS Medical College |
| Address |
Department of Anesthesiology, SMS Medical College and attached
Hospitals, Adarsh Nagar, Jaipur Jaipur RAJASTHAN 302004 India |
| 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 |
| Dr Sidharth |
SMS Medical College, Jaipur. |
Second floor, Dhanvantri complex, Department of Anesthesiology, SMS Medical College and attached
Hospitals, Adarsh Nagar, Jaipur Jaipur RAJASTHAN 302004 India
Jaipur
RAJASTHAN |
8950531827
skapril318@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee, SMS Medical College and attached Hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
preloading with – 20ml/kg
of ringer Lactate
|
Comparing effect of 6% hydroxyethyl starch-450 Versus ringer lactate on
Blood sugar levels during lower limb surgery under subarachnoid block in 150 minutes
|
| Intervention |
preloading with – 20ml/kg
of 6% hroxyethyl Starch-450
|
Comparing effect of 6% hydroxyethyl starch-450 Versus ringer lactate on
Blood sugar levels during lower limb surgery under subarachnoid block in 150 minutes
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective surgery of lower limb under subarachnoid block.
2. Non diabetic Patients
3. BMI<30 Kg/m2
|
|
| ExclusionCriteria |
| Details |
1. Diabetic patients
2. Patients on regular use of steroid
3. Patients on regular use of ascorbic acid
4. Patients having low hematocrit [ pcv <30% ]
5. Pregnancy
6. Chronic kidney and liver diseases
7. Any cardiac disease or coagulation disorders
8. Surgery taking more than 3 hrs
9. Any Addiction (alcohol and drugs abusers)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Blood sugar level |
At 15 min
At 30 min
At 45 min
At 60 min
At 120 min
At 150 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean Heart rate
Mean Systolic blood pressure , Mean diastolic blood pressure, Mean arterial blood pressure
Mean SPo2
|
At 15 min
At 30 min
At 45 min
At 60 min
At 120 min
At 150 min |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
20/09/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hypotension
after spinal anesthesia remains a major clinical problem. Administration of intravenous fluid is one of the most common
interventions in medicine [1].
Fluid resuscitation for
hypovolemic shock is an integral part of acute medical management in the
Intensive Care Unit (ICU) and Operation Theatre (OT) and in the emergency
department. Colloids and crystalloids are also used as co-loading fluids to
limit complications like hypotension following sympathetic blockade in the
central neuroaxial blockade [2].
Ringer
lactate, a balanced salt solution is the most common crystalloid fluid used for
fluid resuscitation. It is also preferred as the fluid of choice for co-loading
in patients following SAB. Commercially available colloids are widely
recommended in several resuscitation guidelines and intensive care algorithms [3
& 4]. |