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
|
|
Primary Sponsor
|
Name |
Sanjoy Kumar Sureka |
Address |
Department of Urology and Renal Transplant, SGPGIMS, Lucknow |
Type of Sponsor |
Other [] |
|
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 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
|
|
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. |