| CTRI Number |
CTRI/2024/03/064865 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
OBSERVATIONAL STUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“TO EVALUATE THE EFFECT OF PNEUMOPERITONEUM ON PERIPHERAL PERFUSION INDEX IN PATIENTS DURING LAPAROSCOPIC SURGERIES UNDER GENERAL ANAESTHESIA. AN OBSERVATIONAL STUDY.†|
|
Scientific Title of Study
|
“TO EVALUATE THE EFFECT OF PNEUMOPERITONEUM ON PERIPHERAL PERFUSION INDEX IN PATIENTS DURING LAPAROSCOPIC SURGERIES UNDER GENERAL ANAESTHESIA. AN OBSERVATIONAL 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. KESA SAHITHI BALAMREDDY |
| Designation |
POST GRADUATE |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, SHAMPURA MAINROAD
Bangalore
KARNATAKA
560045
India |
| Phone |
9030403553 |
| Fax |
|
| Email |
kesahibalam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANTOSH KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B.R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, SHAMPURA MAINROAD
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KESA SAHITHI BALAMREDDY |
| Designation |
POST GRADUATE |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, SHAMPURA MAINROAD
Bangalore
KARNATAKA
560045
India |
| Phone |
9030403553 |
| Fax |
|
| Email |
kesahibalam@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BENGALURU, 560045
KARNATAKA |
|
|
Primary Sponsor
|
| Name |
Dr KESA SAHITHI BALAMREDDY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI,
BENGALURU- 560045
KARNATAKA |
| 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 KESA SAHITHI BALAMREDDY |
DR.B.R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, |
OT COMPLEX,
DEPARTMENT OF ANAESTHESIOLOGY,
K G HALLI,SHAMPURA MAINROAD
560045
Bangalore
KARNATAKA |
9030403553
kesahibalam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective laparoscopic surgeries under general anaesthesia belonging to ASA Class 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. pregnant women
2. patients scheduled for emergency surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the ability of peripheral perfusion index to describe hemodynamic changes occurring during pneumoperitoneum in laparoscopic surgeries under general anaesthesia. |
from the time pneumoperitoneum created till the completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the accuracy of perfusion index in predicting post-induction hypotension.
2. To assess the efficacy of perfusion index in predicting the pressor response during intubation.
|
from the time anaesthesia is induced till 24hours post operatively |
|
|
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)
|
11/04/2024 |
| 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="6"
Days="18" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
- PNEUMOPERITONEUM CREATED DURING LAPAROSCOPIC SURGERY IS A NOXIOUS STIMULI AND IS ASSOCITED WITH TRANSIENT BUT UNPREDICTABLE AND VARIABLE HAEMODYNAMIC CHANGES. - PERIPHERAL PERFUSION INDEX ACTS AS A NON-INVASIVE INDICATOR IN PREDICTING VARIABLE HEMODYNAMIC RESPONSES. |