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Comparative evaluation of Normal Saline & Plasmalyte A for Intraoperative fluid replacement among diabetic patients under Spinal Anaesthesia â?? A Randomized control trial

Comparative evaluation of Normal Saline v/s Plasmalyte A on change in blood glucose levels and electrolyte levels among diabetic patients undergoing surgery under Spinal Anaesthesia â?? A Randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038314
Enrollment
120
Registered
2021-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Normal Saline (NS) vs Plasmalyte A: The randomized fluid shall be given Intravenously as per fluid requirements of the surgery during the duration of surgery. To compensate for the fast

Sponsors

Christian Medical College Research Grant
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age : 30 â?? 85 years Patients of ASA Grade II , with Type II Diabetes Mellitus coming for Surgery under Spinal Anaesthesia

Exclusion criteria

Exclusion criteria: Stage III / IV CKD Patients â?? due to restricted fluid requirements intra operatively Severe Cardiac disease Coagulopathy Patients with known impaired acid base status

Design outcomes

Primary

MeasureTime frame
To study the metabolic variations on using the 2 types of fluids by comparing the variations (Pre operative and Post operative) in a) Acid base status b) Electrolyte levels c) Base Excess Timepoint: The Baseline ABG (Arterial Blood Gas) shall be taken before giving spinal anaesthesia. The Outcome shall be assessed at the end of surgery by an Arterial Blood Gas analysis.

Secondary

MeasureTime frame
Change in Blood Glucose Concentration as inferred by glucometryTimepoint: Baseline blood glucose level shall be taken from the ABG sample before giving spinal anaesthesia. At the end of surgery , before shifting the patient to the recovery , the Outcome shall be assessed by Blood glucose levels in the Post Intervention ABG Sample.

Countries

India

Contacts

Public ContactDr Ajay A

Christian Medical College , Vellore

balooswamy@gmail.com9894171613

Outcome results

None listed

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