| CTRI Number |
CTRI/2025/02/080542 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Comparing the changes and relationship between expired carbon dioxide and arterial carbon dioxide on abdominal insufflation with carbon dioxide in laparoscopic surgeries. |
|
Scientific Title of Study
|
EtCO2 vs PaCO2: Changes and correlation on CO2 insufflation in laparoscopic surgeries. |
| 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 M Senthil |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical college |
| Address |
Room number 15,Department of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
9843127550 |
| Fax |
|
| Email |
marappansenthil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Nivetha |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical college |
| Address |
Room number 15,Depatment of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
9901198298 |
| Fax |
|
| Email |
niv.tarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sankami T |
| Designation |
PG student |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical college |
| Address |
Room number 15,Depatment of Anaesthesiology
Salem
TAMIL NADU
636308
India |
| Phone |
9095616671 |
| Fax |
|
| Email |
sankamikannan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variyar Medical College and Hospitals,Salem-636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals |
| Address |
Chinnaseragapadi,Salem-636308 |
| Type of Sponsor |
Private medical college |
|
|
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 Sankami T |
Vinayaka Missions Kirupanada Variyar Medical College and Hospitals |
Room number 15,Depatment of Anaesthesiology
Salem
TAMIL NADU |
9095616671
sankamikannan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe,Vinayaka missions kirupanandha variyar medical college and hospitals,salem. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
cholelithiasis,appendicitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparison of Etco2 and Paco2 |
to compare etco2 and paco2 before insufflation and 1/2 hr after insufflation with co2 in laparoscopic surgeries |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA physical status 1,2
2)both genders
3)age between 20-60yrs
4)surgeries less than 2 hours duration |
|
| ExclusionCriteria |
| Details |
1)patient refusal
2)smokers
3)patient having cardiovascular and pulmonary diseases
4)obese patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in Etco2 and Paco2 before and after insufflation with co2 and the correlation between both in laparoscopic surgeries |
o mins at induction to 30 mins after insufflation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of co2 insufflation on hemodynamic and the biochemical parameters of the patient |
o mins at induction to 120 mins after insufflation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a prospective observational analytical study comparing the changes in Etco2 and Paco2 before and after insufflation with co2 and correlation between both laparoscopic surgeries. |