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A clinical trial to study the effects of three different intravenous fluids in patients undergoing surgery for removal of brain tumours

Comparison of 0.9% normal saline, Sterofundin and Plasmalyte with respect to metabolic parameters and brain relaxation in patients undergoing supratentorial craniotomy: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023991
Enrollment
90
Registered
2020-03-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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 Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Sterofundin: Patients will receive only Sterofundin as the sole intravenous fluid throughout the perioperative period, extending till 6 hours postoperatively. Intervention2: Plasmalyte

Sponsors

Department of Neuroanaesthesia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I and II aged 18 to 65 years undergoing craniotomy and excision of supratentorial tumours under general anaesthesia at Neurosciences centre, AIIMS, New Delhi.

Exclusion criteria

Exclusion criteria: 1. Patient refusal to participate 2. Radiological findings suggesting tumour size >60mm, meningioma, high grade glioma, midline shift 3. Sellar and suprasellar tumours 4. Patients on acetazolamide preoperatively

Design outcomes

Primary

MeasureTime frame
Change in base excess and chloride level in arterial blood gas sampleTimepoint: Basseline Tumor excision Surgery end 6 hours postoperatively

Secondary

MeasureTime frame
Brain relaxation as described by the surgeon on a subjective 4-point scale where 1 denotes perfectly relaxed brain, 2 acceptably relaxed, 3 firm brain and 4 budging brain.Timepoint: After elevation of skull bone flap;Incidence of renal dysfunction by change in neutrophil gelatinase-associated lipocalin (NGAL).Timepoint: 6 hours postoperatively;Other metabolic parameters on ABG.Timepoint: Basseline Tumor excision Surgery end 6 hours postoperatively;Perioperative morbidity such as blood loss and mechanical ventilation more than 24 hours.Timepoint: Intraoperative 24 hours postoperatively

Countries

India

Contacts

Public ContactGirija Prasad Rath

AIIMS, New DElhi

girijarath@yahoo.co.in9810602272

Outcome results

None listed

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