| CTRI Number |
CTRI/2022/02/040660 [Registered on: 28/02/2022] Trial Registered Prospectively |
| Last Modified On: |
18/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Prospective |
| Study Design |
Other |
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Public Title of Study
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To observe and compare the effects of anaesthesia, in patients who are undergoing surgery for removal of stones from the kidney in the supine and the prone position. |
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Scientific Title of Study
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Comparison of peri-operative anaesthetic outcomes in patients undergoing percutaneous nephrolithotomy (PCNL) surgery in supine versus prone position:
A prospective observational Study
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAHAVIR |
| Designation |
POSTGRADUATE REGISTRAR |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesia,
Christian Medical College ,Vellore.
Vellore, 632004.
Vellore TAMIL NADU 632004 India |
| Phone |
9442763053 |
| Fax |
|
| Email |
rahavirajendran@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Karen Ruby lionel |
| Designation |
Assosciate professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesia,
Christian Medical College ,Vellore.
Vellore, 632004.
Vellore TAMIL NADU 632004 India |
| Phone |
9442631528 |
| Fax |
|
| Email |
kanjacob@gmail.com |
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Details of Contact Person Public Query
|
| Name |
RAHAVIR |
| Designation |
POSTGRADUATE REGISTRAR |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesia,
Christian Medical College ,Vellore.
Vellore, 632004.
Vellore TAMIL NADU 632004 India |
| Phone |
9442763053 |
| Fax |
|
| Email |
rahavirajendran@gmail.com |
|
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Source of Monetary or Material Support
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| Christian Medical College, vellore |
|
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Primary Sponsor
|
| Name |
Christian Medical College and hospital |
| Address |
Christian Medical College,
Thottapalayam
Vellore-632004 |
| Type of Sponsor |
Private medical college |
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rahavi |
Christian Medical college |
Christian Medical College,in urology operating Rooms 4,5,5a,9,recovery room/surgical ICU, urology wards Vellore TAMIL NADU |
9442763053
rahavirajendran@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
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Intervention / Comparator Agent
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2,3
PATIENTS BETWEEN 18-75 YEARS OF AGE
ELECTIVE PCNL SURGERY |
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| ExclusionCriteria |
| Details |
PATIENT REFUSAL
ASA 4,5
AGE LESS THAN 18 YEARS
ACUTE BRONCHOSPASM DURING THE PERI-OPERATIVE PERIOD
EMERGENCY SURGERY |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare hemodynamic profile and respiratory parameters in patients undergoing percutaneous nephrolithotomy surgery in supine versus prone position. |
Intraoperative and postoperative period |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| To compare Preoperative and postoperative hemoglobin levels2.tomcorrelate electrolyte and metabolic changes with duration of irrigation fluid and volume of irrigation fluid .3.to see difference in the Preoperative and postoperative electrolytes.4.to assess the need for intraoperative transfusion.4.to see the haemodynamic changes associated with the procedure. |
During the preoperative ,intraoperative and postoperative period |
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Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
|
15/03/2022 |
| 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 |
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Estimated Duration of Trial
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Years="0" Months="6" Days="30" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Yes |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
A change in dietary habits as well as global warming have attributed to an increased incidence and prevalence of renal calculi across the globe. The traditional and oldest methods described for the removal of kidney stones are through an open nephrolithotomy access. The advent of endourological procedures since the availability of ureteroscopes and nephroscopes, has been a great advantage with better patient outcomes, a much less incidence of complications and faster discharge from hospital. Percutaneous nephrolithotomy (PCNL) is a minimally invasive technique that provides a direct approach to the renal calculus while the kidney and the surrounding structures are subjected to lesser trauma as compared to the open approach. Thus PCNL is currently considered the technique of choice to remove large renal calculi. Traditionally PCNL is done in the prone position, which allows a direct access to the posterior calyx, provides a safer procedure regarding the location of the bowel and allows a wider field for instrumentation. Apart from complications such as blood loss, sepsis, pleural injury resulting in pneumothorax/ hydrothorax/haemothorax, renal collecting system injury resulting in urinary leakage and hypothermia, providing anaesthesia for PCNL is a challenge with the positioning in the prone position with its associated implications and complications as well. This is more so in the patients with cardiorespiratory comorbidities and in those who are obese. Recently, in our institution, PCNL surgeries are being carried out in the supine or modified supine positions as well. In our prospective, observational study, we plan to evaluate the impact of prone versus supine position with regard to the hemodynamic profile and respiratory parameters. We also plan to assess the other perioperative anaesthetic outcomes such as recovery form anaesthesia and the quality of recovery as assessed by quality of recovery score (QoR 15) at 24 hours after surgery and the DREAM time (time to DR-DRink, E-EAt, and Mobilize- M) after surgery. We will also assess the incidence of post-operative pain, shivering, perioperative complications, duration of hospital stay and compare these parameters between the prone and supine positions.
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