| CTRI Number |
CTRI/2023/04/051540 [Registered on: 12/04/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Tolvaptan in preventing decrease in blood sodium levels after surgery |
|
Scientific Title of Study
|
The Effect of Single Dose of Tolvaptan on the Incidence of Post operative Hyponatremia after major surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanna Vadhanan |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Research Foundation |
| Address |
Department Of Anaesthesiology
Vinayaka Missions Medical College and Hospital,Keezhakasakudy Medu, Kottucherry Post, Karaikal, Puducherry.
Karaikal
PONDICHERRY
609609
India |
| Phone |
|
| Fax |
|
| Email |
vadhanan.prasanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prasanna Vadhanan |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Research Foundation |
| Address |
Department Of Anaesthesiology
Vinayaka Missions Medical College and Hospital,Keezhakasakudy Medu, Kottucherry Post, Karaikal, Puducherry.
Karaikal
PONDICHERRY
609609
India |
| Phone |
|
| Fax |
|
| Email |
vadhanan.prasanna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthik Sarma Akella |
| Designation |
Post Graduate |
| Affiliation |
Vinayka Missions Research Foundation |
| Address |
Department Of Anaesthesiology
Vinayaka Missions Medical College and Hospital,keezhakasakudy Medu, Kottucherry Post, Puducherry.
No 2 Department of Anaesthesia
First floor
Vinayaka Missions Medical College Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
|
| Fax |
|
| Email |
karthiksarma.akella@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Medical College |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Research Foundation |
| Address |
Sankari Main Road (NH-47), Ariyanoor, Salem - 636 308
Tamil Nadu, India. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Karthik Sarma Akella |
Vinayaka Missions Medical College and Hospital |
Room no:2, Department of Anaesthesiology, Vinayaka Missions Medical College and Hospital, Keezhakasakudy Medu, Kotucherry Post, Karaikal, Puducherry, 609609
Karaikal
PONDICHERRY |
9730069543
karthiksarma.akella@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Similar looking placebo tablet orally one hour before surgery |
| Intervention |
Tolvaptan |
Oral tolvaptan 15mg one hour before surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients undergoing major surgeries of more than 2 hours duration under regional or general anaesthesia |
|
| ExclusionCriteria |
| Details |
Bowel obstruction/malabsorption
Chronic renal disease
Electrolyte imbalance
Allergy/contraindication to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum sodium values |
On first postoperative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Urine output
Blood pressure
Postoperative stay |
During surgery
Postoperative period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |