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CTRI Number  CTRI/2019/09/021218 [Registered on: 12/09/2019] Trial Registered Prospectively
Last Modified On: 04/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing the effectiveness of 20% mannitol versus 3% saline to see if there is any difference in outcome of patients who are undergoing surgery for brain tumor.  
Scientific Title of Study   The impact of 3% hypertonic saline versus 20% mannitol on clinical outcomes in patients undergoing elective craniotomy for supratentorial tumours:a prospective randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dona Saha 
Designation  Senior Resident (Academic) 
Affiliation  All India Institue of Medical Sciences Bhubaneswar 
Address  Department of Anesthesia All India Institute of Medical Sciences,Bhubaneswar Khordha

Khordha
ORISSA
751019
India 
Phone  9051575159  
Fax    
Email  donasaha.cnmc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Satyajeet Misra 
Designation  Additional Professor and HOD Anesthesia 
Affiliation  All India Institute Of Medical Sciences, Bhubaneswar 
Address  Department of Anesthesia Academic block All India Institute Of Medical Sciences Bhubaneswar. Khordha Orissa

Khordha
ORISSA
751019
India 
Phone  9438884048  
Fax    
Email  misrasatyajeet@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Satyajeet Misra 
Designation  Additional Professor and HOD Anesthesia 
Affiliation  All India Institute Of Medical Sciences, Bhubaneswar 
Address  Department of Anesthesia Academic block All India Institute Of Medical Sciences Bhubaneswar. Khordha Orissa

Khordha
ORISSA
751019
India 
Phone  9438884048  
Fax    
Email  misrasatyajeet@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Patrapada Dist- Khordha, Bhubaneswar Orissa Pin- 751019 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bhubaneswar 
Address  Bhubaneswar 
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 
Dr Dona Saha  All India Institute Of Medical Sciences Bhubaneswar  Department of Anesthesia All India Institute Of Medical Sciences Bhubaneswar
Khordha
ORISSA 		 9051575159

donasaha.cnmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  20% Mannitol  5 ml/kg 20% Manniol from he time of skin incision till 1 hour. Second dose according to the clinical requirement. 
Intervention  3% Saline  5 ml/kg 3% Saline from the time of skin incision till 1 hour. Second dose according to the clinical requirement. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  •18- 60 years
•Both gender
•ASA I and ASA II
•All supratentorial tumors both intraaxial and extra-axial measuring less than 10 cm in any dimension posted for craniotomy in elective neurosurgery OT in AIIMS Bhubaneswar.  
 
ExclusionCriteria 
Details  1 Emergency cases
2 Receiving Mannitol or HTS in previous 24 hours
3 GCS <10
4 Raised serum creatinine > 1.2 mg/dl
5 Preoperative hyponatremia (Na<130)
6 Preoperative hypernatremia (Na>145)
7 Deep location of tumour. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Duration of postoperative hospital stay   1. Duration of postoperative hospital stay- at the time of discharge. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of ICU stay  Duration of ICU stay in days at the time of discharge from
ICU. 
Any complications during ICU stay
I Infection
II Need for EVD/Shunt placement
III Re-exploration
IV Reintubation
V ICU readmission
VI Tracheostomy
VII Sodium disorder requiring treatment 		 During ICU stay 
Difference in c-reactive protein between 2 groups after 24 hours  After 24 hours from the time of ICU stay 
Difference in serum creatinine between 2 groups at 24 and 48 hours   24 hours and 48 hours after ICU admission. 
Duration of mechanical ventilation (in hours)  Mechanical ventilation in hours during ICU stay 
Need for blood transfusion in the first 24 hours  blood transfusion in first 24 hours during ICU stay 
Intraoperative and 24 hours fluid requirement (in liters)  Intraoperative and first 24 hours in ICU 
3 months mortality and Glasgow outcome scale extended (after hospital discharge)  After hospital discharge, 3 months after hospital discharge 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2019 
Date of Study Completion (India) 25/08/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The prospective randomized controlled trial will seek to evaluate whether there is any difference in clinical outcome among  patients receiving  equi-osmolar doses of 3% hypertonic saline and 20% mannitol undergoing elective  supratentorial craniotomy for brain tumor. The study will comprise of total 140 patients who will be divided into two groups. 70 patients in 3%hypertonic saline group (Group N) and 70 patients in 20% mannitol group (Group M). Anaesthesia will be standardised in both the groups, either of the drug will be given at 5ml/kg body weight dose from the starting of skin incision till 1 hour. Second and subsequent doses will be given according to clinical need. Fluid management will be according to the clinicians discretion. If the hypertonic saline group developes serum sodium level more than 145meq/L and require more doses, they will be cross over to mannitol group and will be analysed at the end of the study as an intention to treat basis. Primary outcome will be the length of postoperative hospital stay between the two groups. 
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