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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  
NIL 
 
Primary Sponsor  
Name  Vijayanagar Institute Of Medical Sciences 
Address  Cantonment,Ballari,583104, Karnataka.  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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