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

Not yet recruiting

• Conditions: Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, (3) ICD-10 Condition: H701||Chronic mastoiditis, (4) ICD-10 Condition: N201||Calculus of ureter, (5) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (6) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast,

• Registration Number: CTRI/2023/04/051540
• Lead Sponsor: Vinayaka Missions Research Foundation

Brief Summary

After obtaining informed written consent, detailed history, complete physical examination and routine investigations for all the patients.

Preoperative serum Na+ K+ Cl- will be measured.

Patients will be divided into two groups Group c and Group s

Group s of 50 will receive Tab.Tolvaptan 15mg and Group c of 50 will receive Tab.placebo 1 hours before the surgery.

Once the patient is shifted into the operation theatre the patients vitals including the hemodynamic parameters such as Blood Pressure, Heart Rate,ECG and SpO2 will be monitored at frequent intervals of 5mins.

Fluid loss during the duration of the surgery will be replaced in the form of lactated ringer solution in 3:1 ratio while the blood loss will be replaced by blood transfusion.

The duration of the surgery will be recorded by marking the start and end time of the procedure.



The postoperative serum electrolytes will be measured on post operative day one.

Electrolytes will be compared in both groups post operatively and statistical analysis will be done to determine the effect of tolvaptan.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-15
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

Bowel obstruction/malabsorption Chronic renal disease Electrolyte imbalance Allergy/contraindication to study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum sodium values	On first postoperative day

Secondary Outcome Measures

Name	Time	Method
Urine output	Blood pressure

Trial Locations

Locations (1)

Vinayaka Missions Medical College and Hospital; 🇮🇳 Karaikal, PONDICHERRY, India

Vinayaka Missions Medical College and Hospital

🇮🇳Karaikal, PONDICHERRY, India

Karthik Sarma Akella

Principal investigator

9730069543

karthiksarma.akella@gmail.com