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Comparison of two medicines used during surgery to assess heart rate,blood pressure, brain tension and electrolyte abnormality in patients undergoing brain surgery

Comparison of equiosmolar concentrations of combination of mannitol and hypertonic saline vs mannitol alone to assess hemodynamic profile, brain relaxation and electrolyte abnormalities in patients undergoing elective supratentorial craniotomy-A Randomised Control Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008189
Enrollment
134
Registered
2017-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Intracranial neoplasms planned for supratentorial craniotomy

Interventions

Intervention1: Combination of mannitol and hypertonic saline.: In the combination group dose of mannitol is 0.375 mg/kg which corresponds to 2ml/kg of 20% mannitol +2ml/kg body weight of 3% hypertonic

Sponsors

Christian medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Supratentorial tumours with midline shift of >0.5mm 2)ASA 2 3)Patient not on diuretics.

Exclusion criteria

Exclusion criteria: 1) Age 2) ASA 3-5 3) Preoperative hyponatremia Serum Na 4) Preoperative hypernatremia Serum Na >145 5) Treatment with any hyperosmotic fluid(mannitol/hypertonic saline)/diuretics in previous 24hrs. 6) H/O Congestive heart failure/chronic kidney disease.

Design outcomes

Primary

MeasureTime frame
Hemodynamic variables.Timepoint: Hemodynamic variables are noted at 0,5,10,15,30,60,75,90,105 and 120 mins—

Secondary

MeasureTime frame
Brain Relaxation based on Surgeons assessmentTimepoint: At the opening of dura;Serum electrolyte levels.Timepoint: 0,30mins and 4 hours;Serum lactateTimepoint: 0,30mins and 4 hours.—

Countries

India

Contacts

Public ContactGeorgene singh

Christian Medical College

snehaeda@gmail.com9655535271

Outcome results

None listed

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