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CTRI Number  CTRI/2019/07/020114 [Registered on: 09/07/2019] Trial Registered Prospectively
Last Modified On: 08/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to evaluate the effects of different levels of air pressures in abdomen during various laparoscopic surgeries of kidney on physiology of patients during and after surgery 
Scientific Title of Study   Evaluation of effect of different pneumoperitoneal pressures in laparoscopic renal surgery with respect to technical feasibility and physiological parameters 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjoy Kumar Sureka 
Designation  Assistant Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  Department of Urology, SGPGIMS, RAEBARELI ROAD

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904749  
Fax    
Email  drsksureka@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sanjoy Kumar Sureka 
Designation  Assistant Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  Department of Urology, SGPGIMS, RAEBARELI ROAD

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904749  
Fax    
Email  drsksureka@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Naveen Kumar 
Designation  Senior Resident 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  Department of Urology, SGPGIMS, RAEBARELI ROAD

Lucknow
UTTAR PRADESH
226014
India 
Phone  8697020604  
Fax    
Email  naveen041988@gmail.com  
 
Source of Monetary or Material Support  
SGPGIMS, Lucknow 
 
Primary Sponsor  
Name  Sanjoy Kumar Sureka 
Address  Department of Urology and Renal Transplant, SGPGIMS, Lucknow 
Type of Sponsor  Other [] 
 
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 
Dr Sanjoy Kumar Sureka  Sanjay Gandhi Postgraduate Institute of Medical Sciences  Department of Urology
Lucknow
UTTAR PRADESH 
8004904749

drsksureka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Pneumoperitoneal pressure  Group I pressure 8-10 mmHg, Group II pressure 10-12 mmHg and Group III pressure 12-14 mmHg 
Intervention  Pneumoperitoneal Pressure in laparoscopic renal surgery  Pressure of gas in abdomen during laparoscopic renal surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients undergoing any of the transperitoneal laparoscopic renal surgery under general anesthesia.
Only elective surgery
Patients with ASA grade I and II status
Minimum duration of surgery 2 hours Radiologically well-defined disease 
 
ExclusionCriteria 
Details  BMI >35 kg/m2
Patients with major co-morbidities having contraindication for general anesthesia
Patients with history of previous transperitoneal laparoscopic or open surgery
Patients in whom only a part of the surgery was performed laparoscopically
Patients with major psychiatric illness
Patients with pre-emptive additional analgesia for postoperative pain relief like nerve blocks or epidural analgesia
Pregnant women  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative pain  6 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative pain  1 hour 
Heart Rate  before insufflation (T1), 10 min after insufflation (T2), 10 min before desufflation (T3), and 10 min after desufflation (T4).  
mean arterial pressure (MAP)  before insufflation (T1), 10 min after insufflation (T2), 10 min before desufflation (T3), and 10 min after desufflation (T4). 
pH  before insufflation (T1), 10 min after insufflation (T2), 10 min before desufflation (T3), and 10 min after desufflation (T4). 
Time to resume normal feeding  Days 
EtCO2  before insufflation (T1), 10 min after insufflation (T2), 10 min before desufflation (T3), and 10 min after desufflation (T4). 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/07/2019 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The present study aims to define the optimal and safe pneumoperitoneal pressure in patients undergoing various transperitoneal laparoscopic renal surgeries at a tertiary care centre considering its effects on patient’s clinical parameters as well as technical feasibility for the surgeons.

This will be a prospective single blinded randomised study performed at a tertiary care teaching hospital in India of 3 months duration. Approximately 80 patients aged 18 years and above, undergoing any of the transperitoneal laparoscopic renal surgery (LRS) under general anesthesia will be included in the study. The study population will be randomized into three strata according to pneumoperitoneal pressure by computer-generated number (Group I pressure 8-10 mmHg, Group II pressure 10-12 mmHg and group III pressure 12-14 mmHg). Patients will be induced by general anesthesia. All patient’s hemodynamic and respiratory parameters and blood gas alterations will be assessed at four specific points during surgery: before insufflation (T1), 10 min after insufflation (T2), 10 min before desufflation (T3), and 10 min after desufflation (T4). The first set of parameters will be noted after induction of anesthesia after obtaining a steady state ventilation and prior to creating pneumoperitoneum (T1) including heart rate (HR), mean arterial pressure (MAP), pH, arterial O2 pressure(pO2), arterial CO2 pressure (pCO2), base excess (BE), end tidal CO2 (ETCO2), , and peak inspiratory pressure (PIP), plateau pressure (PlP) and minute ventilation (MV).

Then, the peritoneal cavity will be insufflated with CO2 after placing umbilical port under vision (Hasson’s technique) using electronic laparoscopic insufflators with an initial flow rate of 3-4 L/min. Other ports will be subsequently placed as per standard steps.

Further sets of same parameters will be recorded 10 min after insufflation (T2), 10 min before desufflation (T3) and 10 min after desufflation (T4) of the peritoneum. Technical feasibility from surgeon’s point of view will be evaluated in terms of successful completion of surgery without conversion to open method at planned pressure with acceptable duration of the surgery, and intraoperative and early postoperative complications. To assess postoperative stress on patient’s physiology, postoperative pain score will be assessed using visual analog scale (VAS) at 1, 6, and 12 h. The time to resume normal solid feeding (as a surrogate marker of disappearance of postoperative nausea and vomiting) will also be noted for all patients.

All the results will be analysed by appropriate statistical methods.

 
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