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It is a study to compare two intravenous fluids in patients of head injury undergoing surgery using normal saline and isotonic balanced crystalloid

Comparison and evaluation of two different crystalloids normal saline and isotonic balanced crystalloid in patients of traumatic brain injury undergoing craniotomy

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027624
Enrollment
50
Registered
2020-09-07
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: S062- Diffuse traumatic brain injury Health Condition 2: S066- Traumatic subarachnoid hemorrhage Health Condition 3: S065- Traumatic subdural hemorrhage

Interventions

Intervention1: To evaluate effects of normal saline versus isotonic balanced crystalloid: To compare and evaluate effects of normal saline and isotonic balanced crystalloid on acid base equilibrium an

Sponsors

Department of Anaesthesiology and Critical Care
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients of either sex scheduled to undergo emergency craniotomy for traumatic brain injury will be enrolled

Exclusion criteria

Exclusion criteria: associated injuries (long bone fracture, thoracic or abdominal injuries), renal or coagulation dysfunctions, electrolyte imbalance, hemodynamic instability, pregnancy and lactation, difficult airway, comorbidities will be excluded from the study

Design outcomes

Primary

MeasureTime frame
Effects on renal functions{blood urea, serum creatinine, serum electrolytes and neutrophil gelatinase-associated lipocalin(NGAL)} acid base equilibrium(pH, base excess and bicarbonate)Timepoint: baseline, induction of anaesthesia, surgical incision, bone flap removal, 1 hour after starting of surgery, closure of skin, shifting to PACU, 12 hours and 24 hours after shifting

Secondary

MeasureTime frame
serum osmolarity coagulation profile(Prothrombin time, Partial thromboplastin time, International normalised ratio)Timepoint: baseline, induction of anaesthesia, surgical incision, bone flap removal, 1 hour after starting of surgery, closure of skin, shifting to PACU, 12 hours and 24 hours after shifting

Countries

India

Contacts

Public ContactAnshul Mundra

Pt. B.D. Sharma PGIMS

mundraanshul@gmail.com9992853636

Outcome results

None listed

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