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CTRI Number  CTRI/2025/05/087889 [Registered on: 29/05/2025] Trial Registered Prospectively
Last Modified On: 26/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of effect of Mannitol and mannitol plus glycerol combination on brain relaxation and systemic hemodynamics in elective tumor surgeries- A Randomized Controlled Trial 
Scientific Title of Study   Comparison of effect of equiosmolar doses of Mannitol and mannitol plus glycerol combination on brain relaxation and systemic hemodynamics in elective supratentorial tumor surgeries- 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  Shanmugappriya 
Designation  Senior resident 
Affiliation  JIPMER 
Address  Department of AAnaesthesiology,Jipmer Campus, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  08124656802  
Fax    
Email  shanmugappriya29@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prasanna Uduppi Bidkar 
Designation  Professor 
Affiliation  jipmer 
Address  Department of Anaesthesiology and critical care, Jipmer Campus, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  94442706168  
Fax    
Email  drprasannabidkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jayanth seshan 
Designation  Additional professor 
Affiliation  jipmer 
Address  Department of Anaesthesiology and Critical care, Jipmer Campus, Dhanvantari Nagar, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  8424017925  
Fax    
Email  drrjayanth.seshan@gmail.com  
 
Source of Monetary or Material Support  
Jipmer intramural fund Jipmer Campus, Dhanvantari Nagar, Puducherry 605006 India 
 
Primary Sponsor  
Name  Jipmer Intramural Fund 
Address  Jipmer Campus, Dhanvantari Nagar, Puducherry 605006 India 
Type of Sponsor  Research institution 
 
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 
DrShanmugappriya  JIPMER  Department of Anaesthesiology and Critical Care ,Jipmer Campus, Dhanvantari Nagar, Puducherry 605006 India
Pondicherry
PONDICHERRY 
8124656802

shanmugappriya29@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Jipmer IEC  Submittted/Under Review 
Jipmer IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C710||Malignant neoplasm of cerebrum, except lobes and ventricles,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  20% Mannitiol   20% Mannitiol ,standard drug 
Intervention  Glycerol 10% and mannitol 10% combination  Intervention is Glycerol 10% and mannitol 10% combination administered over 20 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  18-60 years
GCS more than 13 
 
ExclusionCriteria 
Details  Electrolyte imbalance(hypernatremia)
Patients with severe cardiac, respiratory, or renal disease
Patients with known absolute or relative contraindications for placement of the TEE probe or surgical positioning (prone position or requirement of extreme neck flexion, oesophageal strictures) will be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare brain relaxation score between equiosmolar doses of Mannitol (20%) and mannitol (10%) plus glycerol (10%) combination in patients undergoing elective supratentorial tumor surgeries.  20 minutes after administration of study drug 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the
ï‚· TEE derived parameters [LV end diastolic area (EDA), end systolic area (ESA), fractional area change (FAC), stroke volume (SV), left ventricular outflow tract velocity time integral (LVOT-VTI) and cardiac output (CO) ]
ï‚· Serum osmolarity
ï‚· Subdural ICP
ï‚· Serum sodium,urea,creatinine,urine output
ï‚· Hemodynamic parameters (HR,BP)  
baseline (after induction of anaesthesia), initiation of study drug, completion of study drug infusion, and then 30 minutes for next 2 hours followed by hourly recordings till the end of the procedure.
Blood gas analysis, random blood glucose(RBS), and Serum osmolarity will be performed prior to- and two hours after administration of study drug 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   07/06/2025 
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="2"
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 - NO
Brief Summary   The trial will commence after approval from the Institute ethics committee (IEC) and registration Clinical trials registry of India (CTRI). All participants satisfying the inclusion and exclusion criteria will be enrolled in the study after obtaining written informed consent.Standard pre anaesthetic evaluation of all participants will be performed. Preoperatively, Glasgow coma score (GCS) and imaging parameters including location and size of tumor and midline shift will be noted.
Participants will randomly be allocated into two groups – 20% mannitol (M group), and 10% Glycerol with 10% Mannitol (group G) by a computer-generated randomization table prior to induction of anaesthesia.
In the operating room, peripheral intravenous line will be secured and 0.9% normal saline at 100cc/h will be administered for fluid management. The standard monitors including electrocardiogram (ECG), non-invasive blood pressure (NIBP), and pulse oximeter will be attached. After preoxygenation with 100% O2 for 3 min, general anaesthesia will be induced with 2 mcg/kg fentanyl and 2 mg/kg propofol. Muscle relaxation will be achieved using 0.1 mg/kg vecuronium bromide to facilitate endotracheal intubation. Invasive arterial BP monitoring will be performed in all cases as per protocol. Central venous catheter may be placed depending on surgical requirement. A multiplane Trans esophageal echo probe will be introduced to obtain the mid esophageal long-axis view through which the LVOT diameter (cm) will be recorded. Then the TEE probe will be fixed in the trans-gastric long-axis view and the LVOT-VTI, LV end diastolic area (EDA), end systolic area (ESA), fractional area change, stroke volume (SV), and cardiac output (CO) will be recorded and calculated at baseline.
Intraoperatively, anaesthesia will be maintained using air: oxygen mixture with FiO2 40%, with 0.7–1 minimal alveolar concentration (MAC) of isoflurane. Opioids for analgesia and vecuronium bromide for muscle relaxation will be repeated as per requirement. Ventilatory parameters will be adjusted to maintain normocapnia. HR and invasive arterial blood pressure will be maintained within 20% of the baseline values. Normal saline (0.9%) will be used as maintenance fluid at 2 ml/kg/h with additional replacement for urine output, third space loss, and blood loss. At the time of scalp incision patients will receive 5 ml/kg of either 20% mannitol or 3ml/kg of 10% mannitol with glycerol over a period of 20 minutes. Once the first burr hole is drilled, the operating surgeon will insert a 20G intravenous cannula subdurally for measurement of intracranial pressure. This will be accomplished using a fluid-filled pressure transducer and the value of ICP will be displayed on the monitor. After craniotomy and dural opening, brain relaxation will be assessed by the operating neurosurgeon blinded to the study drug on a four-point scale: Perfectly relaxed – 1, Satisfactorily relaxed – 2, Firm brain – 3, Bulging brain – 4. If surgeon is not satisfied with the degree of brain relaxation on dural opening, an additional bolus dose of 3 ml/kg of Mannitol (Standard drug) will be administered and hyperventilation to a PaCO2 of 30-35 mm Hg will be initiated to provide relaxation for surgical access.
TEE derived parameters- LV end diastolic area (EDA), end systolic area (ESA), fractional area change, stroke volume (SV), left ventricular outflow tract velocity time integral (LVOT-VTI) and cardiac output (CO) are recorded at various time.points- baseline (after induction of anaesthesia), initiation of study drug, completion of study drug infusion, and then 30 minutes for next 2 hours followed by hourly recordings till the end of the procedure.
Details regarding fluid input, blood loss, blood transfused, duration of anaesthesia, extubation will be noted. Blood gas analysis, random blood glucose(RBS), and Serum osmolarity will be performed prior to- and two hours after administration of study drug. At the end of surgery patients will be either extubated or shifted to neurosurgical intensive care unit for elective mechanical ventilation. All data will be recorded on a standard proforma.
 
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