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A clinical trial to study the effect of amino acid infusion on body temperature in patients undergoing knee joint replacement surgery in cold operating room environment.

A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY TO EVALUATE EFFECT OF INFUSION OF AMINO ACID ENRICHED SOLUTION ON THERMOREGULATORY RESPONSE IN PATIENTS UNDERGOING BILATERAL TOTAL KNEE REPLACEMENT SURGERY UNDER COMBINED SPINAL-EPIDURAL ANAESTHESIA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000972
Enrollment
160
Registered
2010-02-19
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

None listed

Interventions

Intervention1: AMINO ACID INFUSION: 2ml/kg/hr i.e. 3.6 kJ/kg/hr, 2hours pre-operatively Control Intervention1: NORMAL SALINE: 2 ml/kg/hr, 2hours preoperatively at room temperature

Sponsors

SANT PARMANAND HOSPITAL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex, of physical status ASA Grade I/II, in the age group of 60 ? 80 years admitted for elective bilateral total knee replacement surgery will be recruited for the study.

Exclusion criteria

Exclusion criteria: 1. Bleeding disorders 2. Spinal deformity/infection 3. Extremes of weight (BMI >30 or BMI<20) 4. Core temperature > 37˚C 5. On vasodilators or medications likely to alter thermoregulation . 6. Clinical hypothyroidism or hyperthyroidism 7. Dysautonomia 8. Known allergy to drugs used in the study 9. Requiring blood transfusion intraoperatively

Design outcomes

Primary

MeasureTime frame
In patients undergoing bilateral total knee replacement under combined spinal-epidural anaesthesia: 1. To evaluate the surface and core temperature changes 2. To compare the surface and core temperature changes 3. To evaluate the effect of amino acid infusion on surface and core temperatures 4. To compare the change in surface and core temperatures in patients receiving amino acid infusion. Timepoint: O.5 degrees difference in fall in temperature in patients receiving amino acid infusion—

Secondary

MeasureTime frame
Decreased mortality and morbidityTimepoint:—

Countries

India

Contacts

Public ContactASLAM AZIZ RIZVI
aslam20@yahoo.com09811054514

Outcome results

None listed

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