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Effect of Tolvaptan in preventing decrease in blood sodium levels after surgery

The Effect of Single Dose of Tolvaptan on the Incidence of Post operative Hyponatremia after major surgeries

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051540
Enrollment
100
Registered
2023-04-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis Health Condition 2: M171- Unilateral primary osteoarthritisof knee Health Condition 3: H701- Chronic mastoiditis Health Condition 4: N201- Calculus of ureter Health Condition 5: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 6: C501- Malignant neoplasm of central portion of breast

Interventions

Intervention1: Tolvaptan: Oral tolvaptan 15mg one hour before surgery Control Intervention1: Placebo: Similar looking placebo tablet orally one hour before surgery

Sponsors

Vinayaka Missions Research Foundation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All adult patients undergoing major surgeries of more than 2 hours duration under regional or general anaesthesia

Exclusion criteria

Exclusion criteria: Bowel obstruction/malabsorption Chronic renal disease Electrolyte imbalance Allergy/contraindication to study drugs

Design outcomes

Primary

MeasureTime frame
Serum sodium valuesTimepoint: On first postoperative day—

Secondary

MeasureTime frame
Urine output Blood pressure Postoperative stayTimepoint: During surgery Postoperative period—

Countries

India

Contacts

Public ContactKarthik Sarma Akella

Vinayaka Missions Research Foundation

vadhanan.prasanna@gmail.com

Outcome results

None listed

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