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Comparison of two different fluid therapies on patients blood pressure and clinical outcomes during brain surgeries in sitting position

Comparison of goal directed hemodynamic therapy and conventional therapy on hemodynamic stability and perioperative clinical outcomes in patients undergoing sitting position neurosurgeries - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076209
Enrollment
30
Registered
2024-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Goal directed hemodynamic therapy group: In GDHT Group, intraoperative fluids therapy will be based on ICON (non invasive cardiac output monitor) parameters. A protocolized approach wi
and CI and contractility indices within normal limits (based on patient’s BMI) . 2.Dobutamine (2-20 mcg/kg/min) if CI and contractility indices less than Normal range (based on patient’s BMI)

Sponsors

G B Pant institute of postgraduate medical education and research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status 1&2 patients scheduled for elective craniotomy in sitting position

Exclusion criteria

Exclusion criteria: Patients with Ischemic Heart Disease, Cardiac arrythmias/ Intracardiac shunts/ Severe valvular heart disease, Uncontrolled hypertension, Renal or hepatic disease, Diabetic patients with autonomic dysfunction, Pregnancy, Cervical canal stenosis

Design outcomes

Primary

MeasureTime frame
Incidence of hypotension among the two groups evaluated by greater than 20% decrease in the mean arterial pressure from the baseline or a MAP less then 65mmHgTimepoint: Awake supine 5mins post induction Prior to preloading with colloid bolus After colloid preload Prior to change of position from supine to sitting 5mins after achieving the sitting position Every 30mins during surgery 5mins after repositioning the patient in supine position

Secondary

MeasureTime frame
Intraoperative variables: Hemodynamics Mean arterial pressure- by invasive intra arterial pressure monitoring Input crystalloids, colloids, blood and urine output Vasopressor and inotrope requirements (Ephedrine, Noradrenaline, Dobutamine) Blood loss and transfusion requirements Quality of brain relaxation will be evaluated by Brain Relaxation scale Difference in Serum Lactate levels from baseline and end of the surgery Difference in Serum NGAL levels from baseline and 2 hrs after the surgery Timepoint: Hemodynamic parameters and Quality of brain relaxation-Intraoperative period Difference in Serum Lactate- Baseline and end of the surgery Difference in Serum NGAL levels from baseline and 2 hrs after the surgery;Postoperative variables. Length of hospital and ICU stay, Occurrence of postoperative complications, Neurological outcomeTimepoint: Until 30days of postoperative period

Countries

India

Contacts

Public ContactDr Monica S Tandon

GB pant institute of postgraduate medical education and research

monicastandon@hotmail.com9718599408

Outcome results

None listed

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