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Effect of three different amounts of glucose during operation in small children

Comparison Of Three Different Dextrose Containing Intra-Operative Fluid Regimens On Glucose Homeostasis And Electrolyte Balance In Neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/01/005360
Enrollment
45
Registered
2015-01-06
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: null- Neonates undergoing major abdominal and thoracic surgeries

Interventions

Intervention1: D1RL: Ringer Lactate with 1% Dextrose
Dose : at 10ml/kg/hr with additional allowance as per requirement
Duration : beginning to end of surgery Intervention2: D2RL: Ringer Lactate with 2% Dextrose
Duration : beginning to end of surgery Control Intervention1: DSRL: 10% dextrose in N/5 saline (maintenace fluid
Dose : 4ml/kg/hr)
+ Ringer lactate (replacement fluid
Dose : at 6ml/kg/hr with additional allowance as per requirement during surgery)
Duration : beginning to end of surgery

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Full term neonates 2. Emergency and elective surgery 3. Haemodynamically stable prior to surgery 4. Blood glucose and electrolyte concentration within normal range.

Exclusion criteria

Exclusion criteria: 1. Preterm 2. Infants of diabetic mothers 3. Inadequate optimisation (hydration, haemodynamics, blood glucose & electrolytes) in pre-operative period 4. Neonates with anticipated gross haemodynamic instability. 5. Neonates in whom arterial arterial cannulation is contraindicated or fails.

Design outcomes

Primary

MeasureTime frame
Arterial Blood Glucose comparisonTimepoint: Pre-operative and at the end of surgery

Secondary

MeasureTime frame
Acid-base parameters (pH, Base deficit, bicarbonate, lactate)Timepoint: Pre-operative and at the end of surgery;Biochemical parameters (free fatty acid, plasma ketone bodies)Timepoint: Pre-operative and at the end of surgery;Elctrolytes (sodium, potassium, chloride, bicarbonate, anion gap)Timepoint: Pre-operative and at the end of surgery;Endocrine stress markers (Glucagon, Insulin, Cortisol)Timepoint: Pre-operative and at the end of surgery

Countries

India

Contacts

Public ContactPriyankar Kumar Datta

All India Institute of Medical Sciences

dkpawar@gmail.com9868397819

Outcome results

None listed

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