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CTRI Number  CTRI/2023/09/057599 [Registered on: 14/09/2023] Trial Registered Prospectively
Last Modified On: 13/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing the vital signs in different pressures of pneumoperitoneum in patients undergoing laparoscopic gall bladder removal  
Scientific Title of Study   An observational study comparing the clinical effects of standard pressure and low pressure pneumoperitoneum in patients undergoing laparoscopic cholecystectomy 
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.Shreyaskumar Awaradi 
Designation  Postgraduate resident 
Affiliation  Dr. B.R. Ambedkar Medical College and Hospital  
Address  OT complex , Department of Anaesthesiology, Dr B R Ambedkar Medical college and Hospital, KG Halli, Bengaluru 560045

Bangalore
KARNATAKA
560045
India 
Phone  7019105728  
Fax    
Email  awaradishreyas1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.M Salim Iqbal  
Designation  Professor, Department of Anaesthesiology 
Affiliation  Dr B R Ambedkar Medical College and Hospital 
Address  OT complex , Department of Anaesthesiology, Dr B R Ambedkar Medical college and Hospital, KG Halli, Bengaluru.

Bangalore
KARNATAKA
560045
India 
Phone  9964651079  
Fax    
Email  drsalim_iqbal@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr.Shreyaskumar Awaradi 
Designation  Postgraduate resident 
Affiliation  Dr B R Ambedkar Medical College and Hospital 
Address  OT complex , Department of Anaesthesiology, DR B R Ambedkar Medical college and Hospital, KG Halli, Bengaluru.

Bangalore
KARNATAKA
560045
India 
Phone  7019105728  
Fax    
Email  awaradishreyas1@gmail.com  
 
Source of Monetary or Material Support  
DR B R Ambedkar Medical College and Hospital 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Shreyaskumar Awaradi  Dr B R Ambedkar Medical College and Hospital   OT complex , Department of Anaesthesiology, Dr B R Ambedkar Medical college and Hospital, KG Halli, Benaguluru.
Bangalore
KARNATAKA 
7019105728

awaradishreyas1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dr BR Ambedkar Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low pressure pneumoperitoneum  Patients posted for elective laparoscopic cholecystectomy under General anaesthesia with low pressure pneumoperitoneum(10mmhg) and evaluation of changes in hemodynamic parameters like heart rate, blood pressure, mean arterial pressure due to pneumoperitoneum during intraoperative period and duration of surgery and comparing postoperative requirement of analgesics 
Comparator Agent  Standard pressure pneumoperitoneum   Patients posted for elective laparoscopic cholecystectomy under General anaesthesia with standard pressure pneumoperitoneum (14mmhg) and evaluation of changes in hemodynamic parameters like heart rate, blood pressure, mean arterial pressure due to pneumoperitoneum during intraoperative period and duration of surgery and comparing postoperative requirement of analgesics 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients posted for elective Laparoscopic cholecystectomy surgeries under General anesthesia

2.American Society of Anaesthesiologists (ASA) class I and II patients.
 
 
ExclusionCriteria 
Details  1. Patients with known history of cardiovascular diseases
2. Pregnant and lactating women
3. Patients with BMI more than 35 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Hemodynamic parameters in patients undergoing laproscopic cholecystectomy at standard & low pressure pneumoperitoneum with standard pressure pneumoperitoneum  Start of surgery
Intra operative period
End of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To compare intraoperative antihypertensive requirement in both groups  Insufflation of Pneumoperitoneum to Desufflation of Pneumoperitoneum 
To compare post-operative pain & analgesic consumption in 24 hours in both groups  24 hour period post surgery 
To compare duration of surgery at different pressures of pneumoperitonium  Intubation to Extubation 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 3 
Date of First Enrollment (India)   25/09/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
The laparoscopic surgical technique is increasingly used for performing a variety of intraabdominal surgeries routinely as it is minimally invasive, surgeries like cholecystectomy, appendectomy, colectomy and hysterectomy among others . It involves gas insufflation into the peritoneal cavity producing pneumoperitoneum which increases intra-abdominal pressure (IAP) to 12-14 mm of Hg (standard pneumoperitoneum). Laparoscopy can also be done with lower IAP of 8-10 mmHg (low pressure pneumoperitoneum). 
        As pneumoperitoneum produces significant changes ,we attempt to compare the hemodynamic changes in patient undergoing laparoscopic cholecystectomy using different intra-abdominal pressures created by carbon dioxide insufflation. The increase in intra-abdominal pressures by carbon dioxide  insufflation into the peritoneal cavity at a standard pressure and prolonged exposure to such pressures can produce changes in the cardiovascular and pulmonary efficiency. Although these changes may be tolerated by healthy individuals with adequate cardiopulmonary reserve, individuals with existing cardiopulmonary ailments, especially in elderly and hemodynamically compromised patients, may not tolerate these changes. 
Increased IAP due to pneumoperitoneum has a biphasic effect on venous return. Due to redistribution of pooled blood from the splanchnic circulation, there is an initial increase in the circulating blood volume, causing increase in the venous return and flow. Further increase in the IAP leads to inferior vena caval compression and decreases venous return with pronounced reduction in cardiac output . However, An emerging trend has been the use of lower IAP which has shown better patient hemodynamics  and lesser postoperative pain ; use of low-pressure pneumoperitoneum in the range of 8-10 mm Hg in an attempt to lower intra-abdominal pressure that could reduce the impact of pneumoperitoneum on the hemodynamic circulation of intra-abdominal organs as well as cardiopulmonary function as lower pressures are claimed to be safe and effective in decreasing cardiopulmonary complications and pain . While providing adequate working space. Still, the confirmation continues to be weak , and the argument remains unresolved.
       Hence we hypothesize low pressure pneumoperitoneum as a safer alternative to the use of standard pressure of pneumoperitoneum during laparoscopic surgeries. The aim of the research is to evaluate the clinical effects elicited by pneumoperitoneum of different pressures (low IAP versus standard IAP) during laparoscopic cholecystectomy.
 
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