| CTRI Number |
CTRI/2024/07/069745 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of intraoperative use of two intravenous fluids(Normal Saline alone versus Normal Saline and Ringers Lactate administered alternatively as maintenance IV fluid in patients undergoing elective neurosurgery |
|
Scientific Title of Study
|
Comparative Evaluation of intra operative use of Normal Saline Versus Normal Saline and Ringers Lactate administered alternatively as maintenance IV fluid in patients undergoing elective neurosurgery :A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR.SIRUSALA SRINIJA |
| Designation |
Junior resident |
| Affiliation |
Department Of Anaesthesiology And Critical Care,VIMS,Ballari. |
| Address |
Department Of Anaesthesiology And Critical Care,
VIMS,
Ballari,
Karnataka
Bellary KARNATAKA 583104 India |
| Phone |
7013918705 |
| Fax |
|
| Email |
srinijasri0308@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR.SIRUSALA SRINIJA |
| Designation |
Junior resident |
| Affiliation |
Department Of Anaesthesiology And Critical Care, VIMS, Ballari. |
| Address |
Department Of Anaesthesiology And Critical Care. VIMS, Ballari, Karnataka.
Bellary KARNATAKA 583104 India |
| Phone |
7013918705 |
| Fax |
|
| Email |
srinijasri0308@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR BALA SUBRAMANYA H |
| Designation |
Professor |
| Affiliation |
Vijayanagar institute of medical sciences,Ballari,Karnataka. |
| Address |
Department Of Anaesthesiology And Critical Care ,VIMS, Ballari,
Karnataka.
Bellary KARNATAKA 583104 India |
| Phone |
9980600724 |
| Fax |
|
| Email |
halsanadu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vijayanagar Institute Of Medical Sciences |
| Address |
Cantonment,Ballari,583104,
Karnataka.
|
| 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 |
| SIRUSALA SRINIJA |
Vijayanagar institute of medical sciences |
Department of Anaesthesiogy And Critical Care, VIMS, Ballari.583104. Bellary KARNATAKA |
7013918705
srinijasri0308@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES, BALLARI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group normal saline |
Intraoperatively only normal saline will be given for whole duration of surgery.
Duration -from starting to completion of surgery. |
| Intervention |
Group normal saline and ringers lactate. |
Intraoperatively for whole duration of surgery alternate normal saline and ringers lactate will be given.
Duration-from starting of surgery to completion of surgery. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective brain surgeries
2.ASA physical status grade 1 and 2
3 patients age group between 18 -60
4.Patients with preoperative GCS morethan or equal to 13
5.BMI less than or equal to 30 |
|
| ExclusionCriteria |
| Details |
1.Patients with pre exixting renal failure (Defined ASD serum creatinine more than 2)
2.Patients with electrolyte imbalance
3.Patients who are already receiving mannitol
4.Patients having Diabetes Mellitus
5.Patients with harmone secreting tumors
6.Patients on steroids for longer durations
7.Intraoperative blood loss more than 1000ml
8.Prolonged surgeries(duration exceeding 6 hrs) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Preoperative and postoperative calculated serum osmolarity at defined intervals |
1.On morning of surgery
2.6 hours after surgery
3.On first post operative day at 9 AM |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Preoperative & post operative serum electrolytes at defined intervals
2.Preoperative & postoperative blood sugars at defined intervals
3.Preoperative & post operative glasgow coma scale
4.Brain relaxation score as assessed by neurosurgeons
5.Total volume of IV fluids administered in 1st six hours of surgery
6. Intraoperative blood loss
7.Duration of surgery |
1.On morning of surgery
2.6 hours after initiation of surgery
3.On first post operative day at 9AM |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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="6" 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
|
After
obtaining written informed consent, 50 patients, meeting the inclusion
criteria will be recruited
for the study. All patients will undergo thorough pre anaesthetic evaluation.
All routine investigations along with necessary special investigations will be
asked for. Location
of tumor, nature of the lesion,
maximum tumor diameter, and features of preoperative raised intracranial
pressure(ICP) as evidenced by the
presence of peri tumoral edema, mass effect, and/or hydrocephalus also will be noted. After overnight
fasting on the morning of surgery, venous blood sample is sent for Serum
electrolytes, Blood urea nitrogen (BUN) and Random blood sugar levels.
In
the operation theatre, standard monitors (electrocardiogram [ECG], non‑invasive
blood pressure [NIBP], and pulse oximeter [SpO2]) will be attached and baseline
parameters noted. An 18 G intravenous cannula will be inserted into one of the
forearm veins. Patients are then randomized allocated to two groups of 25
patients each based on randomly generated numbers as obtained from websitewww.randomizer.org. Allocation
concealment will be done using serially numbered opaque envelope (SNOSE)
method. The patients in the NS group will receive only NS as the maintenance
fluid during the intra operative period flow rate of 2 ml/kg /hr. Patients in
the NSRL group will receive NS followed by RL administered alternatively
through same IV port at flow rate of 2 ml/kg /hr. The operating neurosurgeon will
be blinded to the infused fluid by covering the label. Standard
induction protocol (fentanyl 2 micrograms/kg, propofol 2 mg/kg and vecuronium
0.1 mg/ kg, IV) will be followed in all the patients. Post induction, side
stream airway gas and neuro muscular blockade monitoring will be done. Direct
laryngoscopy and tracheal intubation Will be performed 3‑5 minutes after
administration of the neuromuscular blocker. After intubation with appropriate
size endotracheal tube and confirming the correct placement of endotracheal
tube, patients will be maintained on intermittent positive pressure ventilation
with Oxygen-Nitrous oxide 40:60 with isoflurane. Injection Mannitol 0.5 gm/kg will
be administered intravenous over 20 minutes to all patients before opening of
dura. Blood transfusion will be carried out in accordance with the ASA (American
society of anaesthesiology)practice guidelines and as per institutional
protocol.
Following completion of surgery, the
decision for tracheal extubation will be at the discretion of the attending anesthesiologist in
consultation with operating neurosurgeon. The patients are then shifted to the neurosurgical intensive
care unit for immediate postoperative management and subsequently to the surgical ward.
Qualitative variables are entered as frequency and percentage and
quantitative data as number and mean in MS Excel sheets after filtering of data
will be analyzed applying appropriate statistical tests using latest version of
SPSS software Armonk, NY: IBM Corp. All
qualitative data will be compared using chi square test/Fisher Exact test and
all quantitative data will be compared using student ‘t’ tests if data distribution is normal.
P value <0.05 is considered as statistically significant. |