| CTRI Number |
CTRI/2022/10/046491 [Registered on: 14/10/2022] Trial Registered Prospectively |
| Last Modified On: |
08/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Compare ABGA changes in laparoscopy surgery in smokers and non-smokers patients |
|
Scientific Title of Study
|
A PROSPECTIVE COMPARATIVE STUDY OF ARTERIAL BLOOD GAS PARAMETERS IN SMOKER VS NONSMOKER PATIENTS UNDERGOING LAPAROSCOPIC ABDOMINAL SURGERY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hirenkumar D Patel |
| Designation |
Post graduate resident |
| Affiliation |
B.J.Medical college,Ahmedabad |
| Address |
F3, Department of Anaesthesia, B.J.medical college, civil hospital,asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
7778910794 |
| Fax |
|
| Email |
hirenpatelradhe8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran B Patel |
| Designation |
Associate professor |
| Affiliation |
B.J.Medical college,Ahmedabad |
| Address |
F3,Department of Anaesthesia, B.J.medical college, civil hospital,asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
kiru4576@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran B Patel |
| Designation |
Associate professor |
| Affiliation |
B.J.Medical college,Ahmedabad |
| Address |
F3,Department of Anaesthesia, B.J.medical college, civil hospital,asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9428804290 |
| Fax |
|
| Email |
kiru4576@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
Health and family welfare department, sachivalay, Gandhinagar. |
| Type of Sponsor |
Government 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 Hirenkumar Patel |
Surgical operation theater |
5th floor operation theatre:trauma centre,civil hospital,asarva
Ahmadabad
GUJARAT |
7778910794
hirenpatelradhe8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee , B.J medical college and civil hospital,ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
compare the changes in metabolic and gas exchange status between chronic smokers versus non-smokers in patients posted for laparoscopic abdominal surgery by analyzing blood gas parameters. |
compare the effect of insufflated carbon dioxide during laparoscopic abdominal surgery on arterial blood gas (ABG) parameters like PH, PCO2, andbicarbonate (HCO3), during the pre-operative, intra-operative and post-operative period between smokers and non-smokers. |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 20-60yrs.
2. ASA 1 and 2.
3. Elective laparoscopic surgeries. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. ASA 3 and 4.
3. Patients with other lung and cardiac pathologies.
4. Patients with hypertension, uncontrolled diabetes mellitus, systemic infection,, history of malignancy, history of alcohol or drug abuse.
5. Emergency operation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the abga changes between chronic smokers vs non-smokers in laparoscopic abdominal surgery |
10 minute prior to premedication,10 minute after gas insufflation intraoperative and 10 minute after extubation postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To take proper precautions to avoid complications due to gas insufflation in laparoscopic surgery. |
Intraoperative period and postoperative period up to 12hours. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/10/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable at present |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic surgery is minimally invasive, creation of pneumo-peritoneum and postural changes associated with it causes a number of physiological alterations which may have an effect on the anaesthesia management and warrant specific caution. Absorption of carbon dioxide (CO2) used in insufflation can cause hypercapnia and respiratory acidosis. This further activates the sympathetic nervous and also sensitises the myocardium to catecholamines.This along with a decrease in preload and venous return due to increased intraabdominal pressure may cause a gross decrease in cardiac output. Chronic smoking (more than 20 pack-year at least for 10 years) causes a number of pathological changes in the respiratory system .As the lung function is already in a compromised state in chronic smokers, creation of pneumoperitoneum for laparoscopic surgeries in such patients further aggravates and causes an alteration in the acid-base status of the body. The aim of this study is to compare the changes in metabolic and gas exchange status between chronic smokers versus non-smokers in patients posted for laparoscopic abdominal surgery by analyzing blood gas parameters. |