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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 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   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. 
Scientific Title of Study   Comparison of peri-operative anaesthetic outcomes in patients undergoing percutaneous nephrolithotomy (PCNL) surgery in supine versus prone position: A prospective observational Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
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  
 
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  
 
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  
 
Source of Monetary or Material Support  
Christian Medical College, vellore 
 
Primary Sponsor  
Name  Christian Medical College and hospital 
Address  Christian Medical College, Thottapalayam Vellore-632004 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
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 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
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 
 
ExclusionCriteria 
Details  PATIENT REFUSAL
ASA 4,5
AGE LESS THAN 18 YEARS
ACUTE BRONCHOSPASM DURING THE PERI-OPERATIVE PERIOD
EMERGENCY SURGERY  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
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  
 
Secondary Outcome  
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 
 
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" 
Phase of Trial   N/A 
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 
Estimated Duration of Trial   Years="0"
Months="6"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Yes 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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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