| 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
|
|
|
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
|
|
|
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. |