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A study comparing the effectiveness of 20% mannitol versus 3% saline to see if there is any difference in outcome of patients who are undergoing surgery for brain tumor.

The impact of 3% hypertonic saline versus 20% mannitol on clinical outcomes in patients undergoing elective craniotomy for supratentorial tumours:a prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021218
Enrollment
140
Registered
2019-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: 3% Saline: 5 ml/kg 3% Saline from the time of skin incision till 1 hour. Second dose according to the clinical requirement. Control Intervention1: 20% Mannitol: 5 ml/kg 20% Manniol from

Sponsors

All India Institute of Medical Sciences Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •18- 60 years •Both gender •ASA I and ASA II •All supratentorial tumors both intraaxial and extra-axial measuring less than 10 cm in any dimension posted for craniotomy in elective neurosurgery OT in AIIMS Bhubaneswar.

Exclusion criteria

Exclusion criteria: 1 Emergency cases 2 Receiving Mannitol or HTS in previous 24 hours 3 GCS 4 Raised serum creatinine > 1.2 mg/dl 5 Preoperative hyponatremia (Na 6 Preoperative hypernatremia (Na >145) 7 Deep location of tumour.

Design outcomes

Primary

MeasureTime frame
1. Duration of postoperative hospital stayTimepoint: 1. Duration of postoperative hospital stay- at the time of discharge.

Secondary

MeasureTime frame
3 months mortality and Glasgow outcome scale extended (after hospital discharge)Timepoint: After hospital discharge, 3 months after hospital discharge;Any complications during ICU stay I Infection II Need for EVD/Shunt placement III Re-exploration IV Reintubation V ICU readmission VI Tracheostomy VII Sodium disorder requiring treatmentTimepoint: During ICU stay;Difference in c-reactive protein between 2 groups after 24 hoursTimepoint: After 24 hours from the time of ICU stay;Difference in serum creatinine between 2 groups at 24 and 48 hoursTimepoint: 24 hours and 48 hours after ICU admission.;Duration of ICU stayTimepoint: Duration of ICU stay in days at the time of discharge from ICU.;Duration of mechanical ventilation (in hours)Timepoint: Mechanical ventilation in hours during ICU stay;Intraoperative and 24 hours fluid requirement (in liters)Timepoint: Intraoperative and first 24 hours in ICU;Need for blood transfusion in the first 24 hoursTimepoint: blood transfusion in first 24 hours during ICU stay

Countries

India

Contacts

Public ContactDr Satyajeet Misra

All India Institute Of Medical Sciences, Bhubaneswar

misrasatyajeet@gmail.com9438884048

Outcome results

None listed

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