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To evaluate the effects of same osmolar concentration of 20% mannitol, 3% hypertonic saline and 8.4% sodium bicarbonate on brain relaxation during surgery and vital parameters in patients undergoing surgery for brain tumors above tentorium cerebelli

Evaluation of equiosmolar 20% mannitol, 3% hypertonic saline and 8.4% sodium bicarbonate on intraoperative brain relaxation and hemodynamic parameters in patients undergoing craniotomy for supratentorial tumors: A prospective randomized study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020483
Enrollment
90
Registered
2019-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: D330- Benign neoplasm of brain, supratentorial

Interventions

Intervention1: 3% hypertonic saline and 8.4% sodium bicarbonate: 3% hypertonic saline and 8.4% sodium bicarbonate will be infused and brain relaxation score will be assessed Control Intervention1: 20%

Sponsors

Department research fund
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age 18-60 years 2.ASA- I and II 3.Patients undergoing craniotomy for supratentorial tumors

Exclusion criteria

Exclusion criteria: 1.Patientââ?¬•s refusal to participate in the study 2.Patientââ?¬•s with Glasgow coma score 3.Patientââ?¬•s with signs of herniation 4.Preoperative hyponatremia (serum sodium 150 meq/L) 5.Uncontrolled diabetes or Hypertension 6.History of renal impairment 7.History of unstable angina or myocardial infarction within past 6 months, congestive cardiac failure 8.History of Significant pulmonary disease

Design outcomes

Primary

MeasureTime frame
Brain relaxation on four point scaleTimepoint: Brain relaxation on four point scale—

Secondary

MeasureTime frame
1.To assess the changes in hemodynamic parameters 2.To assess the changes in electrolyte, serum osmolality and urine output 3.To assess any other intra and postoperative complications 4.Patientââ?¬â?¢s ICU and hospital stayTimepoint: All the variables will be measured and recorded before infusion (T0) and after administration of study drug at 15 min (T15), 30 min (T30), 60 min (T60), at 6 h (T360) after infusion and at the time of shifting to ICU/extubation. ICU stay and hospital stay will be assessed post-operatively—

Countries

India

Contacts

Public ContactSanjay Agrawal

AIIMS Rishikesh

docagrawal72@yahoo.co.in9761712630

Outcome results

None listed

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