| CTRI Number |
CTRI/2024/02/063036 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy and safety of spinal anaesthesia for kidney stone surgeries |
|
Scientific Title of Study
|
Clinical efficacy and safety of intrathecal anaesthesia for percutaneous nephrolithotomy - A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and Head |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Dr Aloka Samantaray, Professor and Head, Department of Anaesthesiology, Sri Venkateswara Institute of Medical Sciences, Valmiki circle, Tirupati, Chittoor district, Chittoor, Andhra Pradesh
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
Professor and Head |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Dr Aloka Samantaray, Professor and Head, Department of Anaesthesiology, Sri Venkateswara Institute of Medical Sciences,Valmiki circle, Tirupati, Chittoor district, Chittoor, Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Suraj |
| Designation |
Post graduate |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Dr Uday Suraj, Post graduate, Sri Venkateswara Institute of Medical Sciences, Valmiki circle, Tirupati, Chittoor district, Chittoor, Andhra Pradesh
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
8374193042 |
| Fax |
|
| Email |
usmandem@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Sri Venkateswara Institute of Medical Sciences, Valmiki circle, Alipiri road, Tirupati,
Chittoor district, Andhra Pradesh |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DR ALOKA SAMANTARAY |
Sri Venkateswara Institute of Medical Sciences |
Department of Anaesthesiology, Svims, Valmiki circle, Tirupati
Chittoor
ANDHRA PRADESH |
9493547653
aloksvims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Venkateswara Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Spinal Anaesthesia |
We will be checking for the clinical efficacy and safety of spinal anaesthesia in patients undergoing Percutaneous nephrolithotomy surgery. For this we will perform standard spinal anaesthesia procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients above 18 years scheduled for elective PCNL |
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the study.
Patients with general contraindications to Spinal anesthesia.
Patients with known allergies to Spinal anesthesia drugs.
Pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intraoperative hemodynamic stability will be assessed by observing the number of
episodes of hypotension (systolic blood pressure below 90 mmhg), hypertension (systolic
blood pressure more than 20% from baseline), bradycardia (absolute decrease in heart
rate below 60 beats per minute) and tachycardia (heart rate more than 100 beats per
minute). |
At baseline, during the procedure, before shifting to recovery room |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) To find out conversion rate to general anaesthesia or supplementation to spinal anaesthesia
(2) To find out patient discomfort at the end of surgery (before making the patient supine from prone position) on a likert type scale for discomfort
(3)To find out patient satisfaction at follow up on 1st post operative day on a likert type scale for satisfaction
(4) To find out occurrence of injury to lung & pleura |
(1) During the procedure
(2) At the end of procedure
(3) Post operative day one
(4) During procedure & post operatively
|
|
|
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)
|
04/03/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We will be evaluating the clinical efficacy and safety of intrathecal anaesthesia in patients undergoing percutaneous nephrolithotomy in our institution. We will be recruiting 100 consecutive patients of age greater than 18 years and will be administering spinal anaesthesia. Following this we will be monitoring vitals throughout the procedure. We will also make a note of patient’s discomfort, satisfaction, any injuries to lung and pleura during the follow up postoperatively. |