| CTRI Number |
CTRI/2024/11/076209 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different fluid therapies on patients blood pressure and clinical outcomes during brain surgeries in sitting position |
|
Scientific Title of Study
|
Comparison of goal directed hemodynamic therapy and conventional therapy on hemodynamic stability and perioperative clinical outcomes in patients undergoing sitting position neurosurgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMPATH S |
| Designation |
Senior resident, DM Neuroanesthesia |
| Affiliation |
GB pant institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and intensive care, GB pant institute of post graduate medical education and research, MAMC Campus, New delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
6381575234 |
| Fax |
|
| Email |
drsampaths12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica S Tandon |
| Designation |
Director professor and Head of Department |
| Affiliation |
GB pant institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and intensive care, 6th floor, Academic block, GB pant hospital, New delhi
New Delhi
DELHI
110002
India |
| Phone |
9718599408 |
| Fax |
|
| Email |
monicastandon@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica S Tandon |
| Designation |
Director professor and Head of Department |
| Affiliation |
GB pant institute of postgraduate medical education and research |
| Address |
Department of Anesthesiology and intensive care, 6th floor, Academic block, GB pant hospital, New delhi
New Delhi
DELHI
110002
India |
| Phone |
9718599408 |
| Fax |
|
| Email |
monicastandon@hotmail.com |
|
|
Source of Monetary or Material Support
|
| GB pant institute of postgraduate medical education and research, Maulana Azad Medical college Campus, New Delhi, India-110002 |
|
|
Primary Sponsor
|
| Name |
G B Pant institute of postgraduate medical education and research |
| Address |
Department of anesthesiology and intensive care, Academic block 6th floor, GB pant hospital (GIPMER), New delhi-110002 |
| 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 Sampath S |
GB pant institute of post graduate medical education |
Room No:17, Neurosurgery OT,2nd floor, A block, GB Pant hospital.
New Delhi
DELHI |
6381575234
drsampaths12@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
conventional fluid therapy group |
In conventional group, Normal saline (0.9%) will be administered as a maintenance fluid, to maintain CVP between 6 and 8 mmHg and a urine output of ≥0.5 ml/kg/h.
In case of hypotension, administration of colloids (6% hydroxyethyl starch 130/0.4), vasoactive agents (ephedrine, norepinephrine) and inotropes (dobutamine) will be as per the discretion of the attending neuroanesthesiologist. |
| Intervention |
Goal directed hemodynamic therapy group |
In GDHT Group, intraoperative fluids therapy will be based on ICON (non invasive cardiac output monitor) parameters.
A protocolized approach will be followed, based on the following hemodynamic indices (by ICON non invasive cardio meter).
Patients with an SVV more than 13 or FTC less than normal for their range [based on patient’s body mass index (BMI)] will be considered as fluid responders, and will be given upto three boluses of Normal saline (0.9%) boluses (5ml/kg over 5 mins), till SVV less than 13 or FTC within normal range.
Hypotension (more than 20 % decrease in MAP from the baseline or a MAP less than 65mmHg) will be treated as follows:
1.Ephedrine (three boluses- 6mg IV each, at 5min intervals): If SVRI less than Normal range (based on patients BMI); and CI and contractility indices within normal limits (based on patient’s BMI) .
2.Dobutamine (2-20 mcg/kg/min) if CI and contractility indices less than Normal range (based on patient’s BMI)
3.Norepinephrine (0.01-0.1μg/kg/min) for refractory hypotension.
4.Colloid [Hydroxyethyl starches boluses (200 ml)] will be given if CI less than normal range and SVV more than 13 or FTC less than normal range (based on patients BMI)
|
| Comparator Agent |
Goal directed hemodynamic therapy versus conventional fluid therapy |
We will compare the goal directed hemodynamic therapy (GDHT) and conventional fluid therapy. In GDHT Group, intraoperative fluids therapy will be based on ICON (non invasive cardiac output monitor) parameters (Stroke volume variation, corrected flow time, thoracic fluid content) and in Conventional group fluid therapy will be based on Central venous pressure. And we will compare the both groups in terms of,
1.Occurrence of hypotension
2.Hemodynamics (Mean arterial pressure, Total input/ Urine output, Vasopressor and Inotrope requirement)
3.Brain relaxation score
4.Length of hospital stay and ICU stay
5.Incidence of postoperative complications (AKI,ARDS etc)
6.Neurological outcomes ( will be assessed by mRS scale and GOS-E scale) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1&2 patients scheduled for elective craniotomy in sitting position |
|
| ExclusionCriteria |
| Details |
Patients with
Ischemic Heart Disease,
Cardiac arrythmias/ Intracardiac shunts/ Severe valvular heart disease,
Uncontrolled hypertension,
Renal or hepatic disease,
Diabetic patients with autonomic dysfunction, Pregnancy,
Cervical canal stenosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hypotension among the two groups evaluated by greater than 20% decrease in the mean arterial pressure from the baseline or a MAP less then 65mmHg |
Awake supine
5mins post induction
Prior to preloading with colloid bolus
After colloid preload
Prior to change of position from supine to sitting
5mins after achieving the sitting position
Every 30mins during surgery 5mins after repositioning the patient in supine position |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative variables:
Hemodynamics
Mean arterial pressure- by invasive intra arterial pressure monitoring
Input crystalloids, colloids, blood and urine output
Vasopressor and inotrope requirements (Ephedrine, Noradrenaline, Dobutamine)
Blood loss and transfusion requirements
Quality of brain relaxation will be evaluated by Brain Relaxation scale
Difference in Serum Lactate levels from baseline and end of the surgery
Difference in Serum NGAL levels from baseline and 2 hrs after the surgery
|
Hemodynamic parameters and Quality of brain relaxation-Intraoperative period
Difference in Serum Lactate- Baseline and end of the surgery
Difference in Serum NGAL levels from baseline and 2 hrs after the surgery |
Postoperative variables.
Length of hospital and ICU stay, Occurrence of postoperative complications, Neurological outcome |
Until 30days of postoperative period |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Anesthesia for sitting position neurosurgeries is associated with a serious risk of hemodynamic instability due to various reasons. This hypotension can potentially compromise the cerebral perfusion which leads to poor patient outcome. Hence, maintenance of an adequate preload with optimal fluid administration, and prompt treatment of the hypotension are important goals during sitting position neurosurgeries. Perioperative goal-directed hemodynamic therapy (GDHT) can help to optimize the cardiovascular dynamics, organ perfusion pressure, and tissue oxygen delivery, based on predefined target values of hemodynamic variables that reflect end-organ blood flow in these patients. In contrast to conventional management which is largely guided by vital signs. Hence in this study we aim to compare the effect of GDHT with conventional hemodynamic management during these neurosurgeries. We hypothesize that GDHT provides superior hemodynamic stability and better perioperative patient outcomes than conventional hemodynamic management in patients undergoing sitting position neurosurgeries.
In GDFT group patients, A protocolized approach will be followed, based on the following hemodynamic indices (by ICON non invasive cardio meter, Osypka Medical GmbH). Patients with an SVV > 13 or FTC< normal for their range [based on patient’s body mass index (BMI)] will be considered as fluid responders, and will be given upto three boluses of Normal saline (0.9%) boluses (5ml/kg over 5 mins), till SVV < 13/ FTC within normal range. Hypotension (>20 % decrease in MAP from the baseline or a MAP < 65mmHg) will be treated as follows: Ephedrine (three boluses- 6mg IV each, at 5min intervals): If SVRI < Normal range (based on patients BMI); and CI and contractility indices within normal limits (based on patient’s BMI) . Dobutamine (2-20 mcg/kg/min) if CI and contractility indices < Normal range (based on patient’s BMI) Norepinephrine (0.01-0.1μg/kg/min) for refractory hypotension. Colloid [Hydroxyethyl starches boluses (200 ml)] will be given if CI < normal range and SVV > 13 / FTC < normal range (based on patients BMI) In conventional group patients, Normal saline (0.9%) will be administered as a maintenance fluid, to maintain CVP between 6 and 8 mmHg and a urine output of ≥0.5 ml/kg/h. In case of hypotension, administration of colloids (6% hydroxyethyl starch 130/0.4), vasoactive agents (ephedrine, norepinephrine) and inotropes (dobutamine) will be as per the discretion of the attending neuroanesthesiologist.
|