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Comparison of effect of Mannitol and mannitol plus glycerol combination on brain relaxation and systemic hemodynamics in elective tumor surgeries- A Randomized Controlled Trial

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 - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087889
Enrollment
70
Registered
2025-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C710- Malignant neoplasm of cerebrum, except lobes and ventricles

Interventions

Intervention1: Glycerol 10% and mannitol 10% combination: Intervention is Glycerol 10% and mannitol 10% combination administered over 20 minutes Control Intervention1: 20% Mannitiol: 20% Mannitiol ,s

Sponsors

Jipmer Intramural Fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 18-60 years GCS more than 13

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 20 minutes after administration of study drug—

Secondary

MeasureTime frame
To compare the ? 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) ] ? Serum osmolarity ? Subdural ICP ? Serum sodium,urea,creatinine,urine output ? Hemodynamic parameters (HR,BP)Timepoint: 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—

Countries

India

Contacts

Public ContactJayanth seshan

jipmer

drprasannabidkar@gmail.com94442706168

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026