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CTRI Number  CTRI/2024/12/077678 [Registered on: 05/12/2024] Trial Registered Prospectively
Last Modified On: 04/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Mannitol versus mannitol and glycerol combination for brain relaxation during brain aneurysm surgery 
Scientific Title of Study   COMBINATION OF 10 PERCENT MANNITOL WITH 10 PERCENT GLYCERINE VERSUS 20 PERCENT MANNITOL FOR INTRAOPERATIVE BRAIN RELAXATION IN PATIENTS WITH ACUTE ANEURYSMAL SUBARACHNOID HAEMORRHAGE UNDERGOING CRANIOTOMY AND CLIPPING OF ANEURYSM 
Trial Acronym  MANGL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MITLESH KUMAR 
Designation  Senior Resident 
Affiliation  Postgraduate Institute Of Medical Education And Research 
Address  Dept of Anaesthesia and Intensive Care 4th Floor Nehru Hospital PGIMER
4th Floor Nehru Hospital
Chandigarh
CHANDIGARH
160012
India 
Phone  9114477096  
Fax    
Email  doctormyth14@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MITLESH KUMAR 
Designation  Senior Resident 
Affiliation  Postgraduate Institute Of Medical Education And Research 
Address  Dept of Anaesthesia and Intensive Care 4th Floor Nehru Hospital PGIMER
4th Floor Nehru Hospital
Chandigarh
CHANDIGARH
160012
India 
Phone  9114477096  
Fax    
Email  doctormyth14@gmail.com  
 
Details of Contact Person
Public Query  
Name  MITLESH KUMAR 
Designation  Senior Resident 
Affiliation  Postgraduate Institute Of Medical Education And Research 
Address  Dept of Anaesthesia and Intensive Care 4th Floor Nehru Hospital PGIMER
4th Floor Nehru Hospital
Chandigarh
CHANDIGARH
160012
India 
Phone  9114477096  
Fax    
Email  doctormyth14@gmail.com  
 
Source of Monetary or Material Support  
PGIMER Thesis Grant Fund, SECTOR 12, CHANDIGARH, INDIA, PIN 160012 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Reseach 
Address  PGIMER, Sector 12, Chandigarh, India, 160012 
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 Kiran Jangra  PGIMER Chandigarh  Dept of Anaesthesia and Intensive Care 4th Floor Nehru Hospital PGIMER
Chandigarh
CHANDIGARH 		 09914844330

drkiransharma0117@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate institute of Medical Education and Research, Chandigarh.Institutional Ethics Committee (Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G939||Disorder of brain, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  20% Mannitol  Patients will receive a single dose of 20% mannitol intraoperatively after induction over 15 min. 
Intervention  Mannitol Glycerole combination  Patients will receive a single dose of 10% mannitol plus 10% glycerine combination intraoperatively after induction over 15 min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The patients with acute aSAH are posted for craniotomy and clipping of aneurysm in the
age group between 18-65 years of either age will be enrolled in the study. 
 
ExclusionCriteria 
Details  Patients who received any decongestant in the previous 6 hours
Major organ dysfunction including liver, kidney, and heart.
Patients having Lumbar drain or external ventricular drainage before surgery
 
 
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 
To compare the intraoperative brain relaxation scores  at dura opening 
 
Secondary Outcome  
Outcome  TimePoints 
To compare between the groups: Intraoperative haemodynamic variables including Heart rate, Systolic/Diastolic and
Mean blood pressure. 		 At every 10 min 
To compare between the groups:urine output  Intraoperatively, Postoperatively till 48 hrs 
To compare between the groups: Change in serum osmolarity & blood sugar  at baseline & at one hour after infusion 
To compare between the groups: Number of patients requiring rescue drugs for brain bulge  at dura opening  
To assess change from baseline: Electrolytes (Sodium, Potassium, Calcium  Baseline, 1 hour after infusion, at the end
of surgery.  
To assess change from baseline serum Osmolality  at baseline & one hour after the study infusion.  
To compare the incidence of adverse outcomes
AKI (Using AKIN Criteria)
Hypotension requiring inotropic support
Hemolysis within 24 hours of infusion
mRS
GOSE  		 mRS at Discharge
GOSE at 3 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 3/ Phase 4 
Date of First Enrollment (India)   15/12/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drkiransharma0117@gmail.com].

  6. For how long will this data be available start date provided 15-12-2024 and end date provided 27-11-2024?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Brain relaxation is an important aspect of anesthetic care during intracranial surgery. Optimal brain relaxation improves the surgeon’s operating conditions and is likely to minimize the severity of retraction injury.1 Brain relaxation should be used to describe a clinical entity that has anesthetic, surgical, physiological, and outcome implications 2 . Moreover, they are often recognized as contributors to secondary brain injury, devastating neurological outcomes, and even brain death,
The combination of mannitol and glycerol comprises a combination of two sugars with better osmotic diuretic properties. Either glycerol or mannitol can be administered individually; however, the addition of glycerol to mannitol allows the lower concentration of the agents, hereby, minimizes the side effects of both agents. There is insufficient data to compare the effect of 20% mannitol plus 10% glycerol combination and 20% mannitol with a similar osmotic load in patients with aneurysmal subarachnoid haemorrhage (aSAH). These two drugs, combination of mannitol plus glycerol and mannitol are nearly equimolar. The osmolarity of combination of mannitol plus glycerol is 1049 and mannitol is 1098.Hence the study is planned to compare the brain relaxation score with the combination of mannitol with glycerine versus mannitol alone in patients with aSAH undergoing craniotomy and clipping.
 
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