| 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
|
|
|
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
|
|
|
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. |