| CTRI Number |
CTRI/2021/07/035076 [Registered on: 23/07/2021] Trial Registered Prospectively |
| Last Modified On: |
04/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measurement of blood flow in internal carotid artery (supplying blood to head and neck region) by sonography in patients undergoing gallbladder removal by laparoscopy. |
|
Scientific Title of Study
|
Internal carotid artery blood flow response to anaesthesia, pneumoperitoneum and head up tilt during laparoscopic cholecystectomy: a clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubhina Gupta |
| Designation |
Junior Resident |
| Affiliation |
Mahatma Gandhi University of Medical sciences and Technology |
| Address |
C/O Dr. Avnish Bharadwaj
Department of Anaesthesiology
Mahatma gandhi Medical College and Hospital
RIICO Industrial Area
Sitapura
Tonk Road
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
8308587092 |
| Fax |
|
| Email |
shubhina1492@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avnish Bharadwaj |
| Designation |
Professor, Department of anaesthesiology |
| Affiliation |
Mahatma Gandhi University of Medical sciences and Technology |
| Address |
Department of Anaesthesiology
Mahatma gandhi Medical College and Hospital
RIICO Industrial Area
Sitapura
Tonk Road
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9314882845 |
| Fax |
|
| Email |
avnishbharadwaj1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avnish Bharadwaj |
| Designation |
Professor, Department of anaesthesiology |
| Affiliation |
Mahatma Gandhi University of Medical sciences and Technology |
| Address |
Department of Anaesthesiology
Mahatma gandhi Medical College and Hospital
RIICO Industrial Area
Sitapura
Tonk Road
Jaipur
Dausa
RAJASTHAN
302022
India |
| Phone |
9314882845 |
| Fax |
|
| Email |
avnishbharadwaj1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Hospital, Jaipur |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical college and Hospital |
| Address |
Mahatma Gandhi Medical College and Hospital
RIICO Industrial area
Sitapura
Tonk Road
Jaipur 302022
Rajasthan |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Avnish Bharadwaj |
Department of Anaesthesiology Mahatma Gandhi Medical College and Hospital
RIICO Industrial area
Sitapura
Tonk Road
Jaipur 302022
Rajasthan |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubhina Gupta |
Mahatma Gandhi Medical College and Hospital |
Department of Anaesthesiology
Mahatma Gandhi Medical College and Hospital
RIICO Industrial Area
Sitapura
Jaipur 302022
Jaipur
RAJASTHAN |
8308587092
shubhina1492@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Mahatma Gandhi Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. consenting patients of either sex undergoing elective laparoscopic cholecystectomy under general anaesthesia.
2. Age 18-60 years
3. Non obese patients (BMI equal to or less than 32kg/m2)
4. Patients belonging to physical status ASA grade I/II |
|
| ExclusionCriteria |
| Details |
1. patients falling in criteria but not giving consent to participate in the study.
2. ASAngrade III/IV/V
3. patients with hyperlipidaemia, known coronary artery disease, hyertension, cerebrovascular disease, diabetes mellitus, patients on beta blockers or on statin therapy |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
To derive and study changes in internal carotid artery blood flow ultrasonographically in patients
undergoing elective laparoscopic cholecystectomy under general anaesthesia in terms of internal
carotid artery diameter, internal carotid artery velocity and beat volume |
1- Awake - just before induction of anaesthesia.
2- Two minutes after induction of anaesthesia,
3- Two minutes after creation of pneumoperitoneum and
4- Two minutes after providing head up tilt. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To derive and calculate cardiac output by Liljestrand and Zander formula |
1- Awake - just before induction of anaesthesia.
2- Two minutes after induction of anaesthesia,
3- Two minutes after creation of pneumoperitoneum and
4- Two minutes after providing head up tilt. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2021 |
| Date of Study Completion (India) |
28/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is aimed studying blood flow changes in Internal Carotid Artery in patients undergoing laparoscopic cholecystectomy under general anaesthesia. Diameter and velocity of Internal carotid artery will be calculated using ultrasonography at following time points - before induction of anaesthesia, just after induction, after creation of pneumoperitoneum and after head up tilt, along with other vital parameters like blood pressure, heart rate, oxygen saturation and end tidal carbon dioxide. Significant physiological changes can occur during
1. Induction of anaesthesia
2. Creation of pneumoperitoneum
3. Head up tilt ( reverse Trendelenburg position ) the proposed study further add to our knowledge how the
internal carotid artery blood flow and cardiac output is affected during different stages of
laparoscopic cholecystectomy under general anaesthesia. |