| CTRI Number |
CTRI/2021/03/031857 [Registered on: 10/03/2021] Trial Registered Prospectively |
| Last Modified On: |
14/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Change in Arterial End Tidal Carbon di oxide and bicarbonate during Laparoscopic surgery in Chronic respiratory diseases |
|
Scientific Title of Study
|
Change in Arterial End Tidal carbon di oxide and bicarbonate during Laparoscopic Cholecystectomy in COPD Patients |
| Trial Acronym |
colap |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujeet Rai |
| Designation |
Associate Professor |
| Affiliation |
Dr. RMLIMS LUCKNOW |
| Address |
Dr.RMLIMS
Room No. 9 Administrative Block
Lucknow
UTTAR PRADESH
226010
India
Dr.RMLIMS
Room No. 9 Administrative Block
Lucknow
UTTAR PRADESH
226010
India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9161758940 |
| Fax |
|
| Email |
drsujeetrai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujeet Rai |
| Designation |
Associate Professor |
| Affiliation |
Dr. RMLIMS LUCKNOW |
| Address |
Department of Anaesthesiology
Room No. 9 Administrative Block Dr.RMLIMS LUCKNOW
UTTAR PRADESH
226010
India
Department of Anaesthesiology
Room No. 9 Administrative Block Dr.RMLIMS LUCKNOW
UTTAR PRADESH
226010
India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9161758940 |
| Fax |
|
| Email |
drsujeetrai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neeraj Gautam |
| Designation |
Junior resident |
| Affiliation |
Dr. RMLIMS LUCKNOW |
| Address |
Dept. Of Anaesthesiology
Dr. RMLIMS
Room NO. 509
Lucknow
Dept. Of Anaesthesiology
Dr. RMLIMS
Room NO. 509
Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7289948481 |
| Fax |
|
| Email |
neerajgautam11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr RMLIMS
Dept.Of Anaesthesiology vibhuti khand
Gomati Nagar
Lucknow 226010
Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr SUJEET RAI |
| Address |
Dr.RMLIMS LUCKNOW
|
| Type of Sponsor |
Other [self] |
|
|
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 Sujeet Rai |
Dr Ram Manohar logia institute of medical sciences VIbhuti khand gomati Nagar Lucknow |
Department of Anaesthesiology Room No 9
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
9161758940
drsujeetrai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR RMLIMS LUCKNOW |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients who has given valid informed consent
ASA physical grade 2
Patients undergoing laparoscopic cholecystectomy in COPD patients
Patients suffering from respiratory diseases like chronic bronchitis, emphysema, bronchial asthma
Patients who posted for elective surgery
Weight BMI<25 Kg/m2
|
|
| ExclusionCriteria |
| Details |
Patients refusal
History of haemorrhagic diathesis and clotting disorder
Patients with the pre existing congestive heart failure or kidney disease
Known allergy or sensitivity to drugs
Patient posted for emergency procedure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Aim of the study is to assess the change in arterial end tidal carbon di oxide and bicarbonate during laparoscopic cholecystectomy in COPD patients |
2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the Peak airway pressure changes and acid base changes during laparoscopic cholecystectomy in COPD patients
To see pathological effects if any due to such changes in patients undergoing laparoscopic cholecystectomy in COPD patients
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2021 |
| Date of Study Completion (India) |
19/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
19/12/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. The Aim of the study is to assess
the change in arterial, end tidal CO2 and HCO3 during laparoscopic
cholecystectomy in COPD patients
2. To determine the Peak airway
pressure changes and acid base changes (PH, HCO3) during
laparoscopic cholecystectomy in COPD patients
3. To see pathological effects if
any due to such changes in patients undergoing laparoscopic cholecystectomy in
COPD patients |