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CTRI Number  CTRI/2025/01/079245 [Registered on: 22/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of gradual increase in carbon dioxide pressure for abdomen insufflation on heart rate in laparoscopic abdominal surgery: A Prospective Randomised study  
Scientific Title of Study   Effect of gradual increase in intra-abdominal pressure on bradycardia during creation of pneumoperitoneum in laparoscopic abdominal surgery: A Prospective Randomised study 
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 Sudhansu Sekhar Nayak 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  Room no. 5011 Department of Anesthesiology, pain medicine & critical care, AIIMS, New Delhi, Ansari Nagar
Department of Anesthesiology, pain medicine & critical care, AIIMS, New Delhi, Ansari Nagar
New Delhi
DELHI
10029
India 
Phone  8874756836  
Fax    
Email  nayak.sudhansusekhar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudhansu Sekhar Nayak 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  Room no. 5011 Department of Anesthesiology, pain medicine & critical care, AIIMS, New Delhi, Ansari Nagar
Department of Anesthesiology, pain medicine & critical care, AIIMS, New Delhi, Ansari Nagar
New Delhi
DELHI
10029
India 
Phone  8874756836  
Fax    
Email  nayak.sudhansusekhar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sudhansu Sekhar Nayak 
Designation  Assistant Professor 
Affiliation  AIIMS New Delhi 
Address  Room no. 5011 Department of Anesthesiology, pain medicine & critical care, AIIMS, New Delhi, Ansari Nagar
Department of Anesthesiology, pain medicine & critical care, AIIMS, New Delhi, Ansari Nagar
New Delhi
DELHI
10029
India 
Phone  8874756836  
Fax    
Email  nayak.sudhansusekhar@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India PIN- 110029 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  ANSARI NAGAR, NEW DELHI, PIN- 110029 
Type of Sponsor  Research institution and hospital 
 
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 Sudhansu Sekhar Nayak  All India Institute of Medical Sciences, New Delhi, Ansari Nagar  Department of Anesthesiology pain medicine and critical care. Surgical block operation theater no - 2,3,4,5,6,9,10. Mother and child block operation theater no.- 6,7,9
New Delhi
DELHI 
8874756836

nayak.sudhansusekhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES  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  1.Gradual Insufflation Group (Intervention):  Patients will undergo a gradual insufflation technique where the intra-abdominal pressure (IAP) is preset at 8 mmHg and then gradually increased in a stepwise increment of 2mmHg after 60 seconds, then 2 mmHg after 60 seconds, and 2 mmHg after 60 seconds. (over a total duration of 3 minutes). Flow setting of the CO2 gas will be 3L/minute.  
Comparator Agent  2.Rapid Insufflation Group (Control):  Patients will undergo conventional rapid insufflation to a preset IAP of 14 mmHg, which is the standard practice in many centres. Flow setting of the CO2 gas will be 3L/minute. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Adult patients ( above 18 years old) undergoing laparoscopic abdominal surgery
2.ASA (American Society of Anesthesiologists) physical status I,II,III.
 
 
ExclusionCriteria 
Details  1.Patients refusal for participation and consent 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of bradycardia   during creation of pneumoperitoneum(T0 minute) 
 
Secondary Outcome  
Outcome  TimePoints 
1.Incidence of Tachycardia
2.Incidence of Hypotension
3.New ECG Changes
4.Pharmacological Intervention required
 
during creation of pneumoperitoneum(T0 minute) 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/02/2025 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Laparoscopic surgery because of its minimal invasive nature, is now a preferred technique for a range of surgical procedures including cholecystectomy, appendectomy, hernioplasty, various gynaecological surgeries and advanced surgeries like colorectal, pancreatic, urological surgeries and endocrine surgery like adrenalectomy etc. It involves the creation of pneumoperitoneum through the insufflation of carbon dioxide (COâ‚‚) into the abdominal cavity to provide space for surgical manipulation. One of the well-known physiological responses to pneumoperitoneum is increased intra-abdominal pressure (IAP) and vagal stimulation causing bradycardia, a slow heart rate (<60 bpm) that can be clinically significant when it drops below 40 beats per minute or sometimes asystole causing significant hemodynamic instability and may require pharmacological intervention, such as the administration of atropine. And these bradycardia event occur mostly at the time of creation of pneumoperitoneum. The incidence of laparoscopy-induced bradycardias has been reported to range widely between 3.4 and 28% of cases. The current standard practice for pneumoperitoneum creation typically involves rapid insufflation of COâ‚‚ to achieve the desired intra-abdominal pressure (IAP) of 12-14 mmHg rapidly. However, this rapid inflation may exacerbate the incidence of bradycardia by abruptly increasing intra-abdominal pressure, thus affecting cardiovascular function. While gradual insufflation, where pressure is increased in small, incremental steps to increase IAP gradually may provide a more controlled response, potentially reducing the vagal response and the incidence of bradycardia. Despite these theoretical concepts, evidence supporting the superiority of gradual insufflation over rapid insufflation in reducing bradycardia during laparoscopic abdominal surgery is sparse and inconclusive. This study aims to fill this gap by investigating whether a gradual increase in IAP during pneumoperitoneum creation can reduce the incidence and severity of bradycardia compared to the conventional rapid insufflation technique. Specifically, this study will assess whether a gradual increase in intra-abdominal pressure (IAP) reduces the incidence of bradycardia (defined as a heart rate of less than 60 beats per minute or a reduction of more than 20% from baseline) when compared to the conventional rapid inflation technique. Given the high prevalence of bradycardia in laparoscopic abdominal surgeries, particularly with the rapid inflation method, the findings from this research may contribute to optimizing anesthetic and surgical protocols, improving patient safety, reducing perioperative cardiovascular complications and better overall patient outcomes.

 
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