| CTRI Number |
CTRI/2020/01/022911 [Registered on: 22/01/2020] Trial Registered Prospectively |
| Last Modified On: |
21/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The patients undergoing routine endoscopic urological surgeries are choosen and are subjected to assessment of left ventricular diastolic function and later are assessed for intra-operative haemodynamic changes and intra-operative and post-operative complications |
|
Scientific Title of Study
|
ventricular diastolic dysfunction in patients undergoing routine endoscopic urological surgeries under regional anaesthesia and its correlation with intra-operative and post-operative events |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJyoti Pathania |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical college |
| Address |
Department of Anaesthesia
IGMC
Shimla
Department of Anaesthesia
IGMC
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418120659 |
| Fax |
|
| Email |
pathaniajyoti7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJyoti Pathania |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical college |
| Address |
Department of Anaesthesia
IGMC
Shimla
Department of Anaesthesia
IGMC
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418120659 |
| Fax |
|
| Email |
pathaniajyoti7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshan B K |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical college |
| Address |
Department of Anaesthesia
IGMC
Shimla
Department of Anaesthesia
IGMC
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9482352841 |
| Fax |
|
| Email |
darshanbkd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,Indira Gandhi medical college,Shimla
171001 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College |
| Address |
Indira Gandhi Medical College
Shimla
171001 |
| Type of Sponsor |
Government 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 |
| DrJyoti Pathania |
Indira Gandhi Medical College,Shimla |
Department of Anaesthesia
Shimla
HIMACHAL PRADESH |
9418120659
pathaniajyoti7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee IGMC Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing routine endoscopic urological surgeries |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the prevalence and degree of diastolic dysfunction in patients more than 50 years presenting for routine endoscopic urological surgeries |
Baseline:preoperative echocardiographic examination for assessment of left ventricular diastolic dysfunction and its degree |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the impact of degree of diastolic dysfunction on intraoperative haemodynamic changes
2.To record adverse intraoperative events if any
3.To observe adverse postoperative events if any |
Baseline:pre-operative echocardiographic examination and intra-operative haemodynamic changes and intra-operative and post-operative complications are monitored |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
25/01/2020 |
| 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="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this trial "left ventricular diastolic dysfunction in patients undergoing routine endoscopic urological surgeries under regional anaesthesia and its correlation with intraoperative and postoperative events" ,we preoperatively subject the patient to echocardiographic assessment and observe for and also classify the grade of diastolic dysfunction.Intraoperatively we intend to monitor the haemodynamic changes associated with the diastolic dysfunction while also monitoring for any intraopertive complications.Post operatively we intend to observe for any complications and treat them as per the existing guidelines. |