| 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
|
|
|
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
|
|
|
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. |