| CTRI Number |
CTRI/2025/02/081172 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pre Operative Evaluation of Caval Aorta Diameter Index as a Predictor of Post induction Hypotension in Laparoscopic Cholecystectomy Surgery |
|
Scientific Title of Study
|
Pre Operative Evaluation of Caval Aorta Diameter Index as a Predictor of Post induction Hypotension in Laparoscopic Cholecystectomy |
| 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 Mamta Harjai |
| Designation |
Professor |
| Affiliation |
Dr Ram Manohar Lohia Institute of medical sciences |
| Address |
Department of Anaesthesiology and Critical Care medicine
Dr. RMLIMS, Vibhuti Khand, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007015 |
| Fax |
|
| Email |
mamtaharjaidoctor@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Harjai |
| Designation |
Professor |
| Affiliation |
Ram Manohar Lohia institute |
| Address |
Department of anaesthesiology and critical care medicine, Dr. RMLIMS, vibhuti khand, lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007015 |
| Fax |
|
| Email |
mamtaharjaidoctor@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niharika Singh |
| Designation |
Junior Resident |
| Affiliation |
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology and Critical Care medicine, Dr. RMLIMS, Vibhuti Khand, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8400728318 |
| Fax |
|
| Email |
niharika97.singh@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Dr Ram manohar lohia Institute of medical sciences, Vibhuti Khand, Lucknow, 226010 |
|
|
Primary Sponsor
|
| Name |
Dr Ram Manohar Lohia Institute of medical sciences |
| Address |
Dr. RMLIMS, Vibhuti Khand, Lucknow, 226010 |
| 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 Niharika Singh |
Dr Ram Manohar Lohiya Institute of Medical Sciences |
Department of Anaesthesia, Vibhuti Khand, Gomti nagar, Lucknow
Lucknow
UTTAR PRADESH |
8400728318
niharika97.singh@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr RMLIMS Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2 patients with body weight 50 to 70 kilograms scheduled for elective laparoscopic cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal to give consent,
2. Significant cardiac comorbidity (significant arrhythmia, severe valvular disease, unstable angina, implanted pacemaker, ejection fraction <50%),
3. BMI>30 Kg/m2
4. Patient taking Angiotensin Receptor Blockers
5. Systolic blood pressure <90 mmHg or mean arterial blood pressure (MBP) less than 70 mmHg
6. Pregnancy
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of Caval aorta diameter index |
in the pre operative room at 1 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart Rate, Mean arterial blood pressure, peripheral saturation of oxygen, systolic blood pressure, diastolic blood pressure |
The heart rate & systolic blood pressure shall be recorded every 2 minutes after induction for 5 minutes & then every 5 minutes till 15 minutes post induction |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
05/03/2025 |
| 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="6"
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
|
Early prediction of pre operative volume status of the patient is paramount to allow at-risk patients to take appropriate preventive measures.in view of pre operative volume status assessment, ultrasound measurements of inferior vena cava diameter during respiration, including maximum ivc diameter and minimum ivc diameter at the end of respiration during spontaneous breathing and collapsilibity index will be measured. A new parameter known as caval aorta diameter index will be measured and used as an assessment tool to predict the degree of post induction hypotension in patients posted for elective laparoscopic cholecystectomy. |