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Changes in patients undergoing craniotomy and tumors excision time

Effects of equiosmolar 3% hypertonic saline, 8.4% sodium bicarbonate & 20% mannitol on intracranial pressure and metabolic changes in patients undergoing supratentorial craniotomy and tumors excision: a prospective, randomized controlled study - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057774
Enrollment
75
Registered
2023-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Health Condition 1: G061- Intraspinal abscess and granuloma

Interventions

Intervention1: Brain relaxation score will be assessed by the operating surgeon immediately on opening the duramater on a four-point scale: 24hrs -48hrs Control Intervention1: hospital and neurologica

Sponsors

Department of Neurosurgery
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient of either sex, Age group of 18-60 years ASA Grade I and II Elective Supratentorial Craniotomy

Exclusion criteria

Exclusion criteria: Patient refusal Hyponatremia or Hypernatremia (Serum Na 150 mEq/L) Pregnancy Cardiac dysfunction with dysrhythmia Renal dysfunction History of recent craniotomy/Head injury ( Active psychiatric or neurological disorders

Design outcomes

Primary

MeasureTime frame
•To compare the effect of equimolar 3% Hypertonic Saline, 8.4 % Sodium Bicarbonate & 20% mannitol on intracranial pressure (ICP).Timepoint: 48 hrs to 72 hrs

Secondary

MeasureTime frame
To compare the following parameters between the groups: Cerebral perfusion pressure (CPP), Brain relaxation, Metabolic changes (ABG, Serum Osmolarity) & electrolytes, Hemodynamic parameters Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Central Venous Pressure (CVP). The neurological outcome at the time of discharge of patient from the hospital (Extended Glasgow Outcome Scale (GOS-E), Complications if any like Hypotension, hyponatremia, hypernatremia, hyperkalemia, hypokalaemiaTimepoint: at the time of surgery

Countries

India

Contacts

Public ContactPROF B B KUSHWAHA

King Georges Medical University Lucknow

brij_kushwaha00634@yahoo.com9336900634

Outcome results

None listed

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