Mannitol versus mannitol and glycerol combination for brain relaxation during brain aneurysm surgery

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 - MANGL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077678

Enrollment

200

Registered

2024-12-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: G939- Disorder of brain, unspecified Health Condition 2: O- Medical and Surgical Health Condition 3: O- Medical and Surgical Health Condition 4: G938- Other specified disorders of brain

Interventions

Intervention1: Mannitol Glycerole combination: Patients will receive a single dose of 10% mannitol plus 10% glycerine combination intraoperatively after induction over 15 min Control Intervention1: 20

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To compare the intraoperative brain relaxation scoresTimepoint: at dura opening	—

Secondary

Measure	Time frame
To compare between the groups: Intraoperative haemodynamic variables including Heart rate, Systolic/Diastolic and Mean blood pressure.Timepoint: At every 10 min;To compare between the groups:urine outputTimepoint: Intraoperatively, Postoperatively till 48 hrs;To compare between the groups: Change in serum osmolarity & blood sugarTimepoint: at baseline & at one hour after infusion;To compare between the groups: Number of patients requiring rescue drugs for brain bulgeTimepoint: at dura opening;To assess change from baseline: Electrolytes (Sodium, Potassium, CalciumTimepoint: Baseline, 1 hour after infusion, at the end of surgery.;To assess change from baseline serum OsmolalityTimepoint: 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 GOSETimepoint: mRS at Discharge GOSE at 3 months	—

Measure

Time frame

To compare between the groups: Intraoperative haemodynamic variables including Heart rate, Systolic/Diastolic and Mean blood pressure.Timepoint: At every 10 min;To compare between the groups:urine outputTimepoint: Intraoperatively, Postoperatively till 48 hrs;To compare between the groups: Change in serum osmolarity & blood sugarTimepoint: at baseline & at one hour after infusion;To compare between the groups: Number of patients requiring rescue drugs for brain bulgeTimepoint: at dura opening;To assess change from baseline: Electrolytes (Sodium, Potassium, CalciumTimepoint: Baseline, 1 hour after infusion, at the end of surgery.;To assess change from baseline serum OsmolalityTimepoint: 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 GOSETimepoint: mRS at Discharge GOSE at 3 months

—

Countries

India

Contacts

Public ContactMITLESH KUMAR

Postgraduate Institute Of Medical Education And Research

doctormyth14@gmail.com9114477096

Outcome results

None listed

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