| CTRI Number |
CTRI/2024/06/069128 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Prospective |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An observational study to determine haemodynamic stability and renal outcomes in patients undergoing renal transplantation under either BIS monitored Propofol based Total Intravenous Anaesthesia (TIVA) or MAC monitored Sevoflurane based inhalational anaesthesia |
|
Scientific Title of Study
|
An observational study to determine haemodynamic stability and renal outcomes in patients undergoing renal transplantation under either Bispectral Index (BIS) monitored Propofol based Total Intravenous Anaesthesia (TIVA) or Minimum Alveolar Concentration (MAC) monitored Sevoflurane based inhalational anaesthesia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EC/NEW/INST/2023/WB/0335 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anirban Mandal |
| Designation |
DNB Anaesthesiology Post Graduate Trainee |
| Affiliation |
Apollo Multispeciality Hospitals Ltd. |
| Address |
Department of Anaesthesiology, Main Block, 1st floor OT Complex.
58, Canal Circular Rd, Kadapara, Phool Bagan, Kankurgachi
Kolkata
WEST BENGAL
700054
India |
| Phone |
|
| Fax |
|
| Email |
anirban1010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saikat Sengupta |
| Designation |
Senior Consultant, Department of Anaesthesiology |
| Affiliation |
Apollo Multispeciality Hospitals Ltd |
| Address |
Department of Anaesthesiology, Main Block, 1st floor OT Complex.
58, Canal Circular Rd, Kadapara, Phool Bagan, Kankurgachi
Kolkata
WEST BENGAL
700054
India |
| Phone |
9830179539 |
| Fax |
|
| Email |
saikatsg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saikat Sengupta |
| Designation |
Senior Consultant, Department of Anaesthesiology |
| Affiliation |
Apollo Multispeciality Hospitals Ltd |
| Address |
Department of Anaesthesiology, Main Block, 1st floor OT Complex.
58, Canal Circular Rd, Kadapara, Phool Bagan, Kankurgachi
Kolkata
WEST BENGAL
700054
India |
| Phone |
9830179539 |
| Fax |
|
| Email |
saikatsg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Multispeciality Hospitals Ltd.
58 Canal Circular Road, Kadapara, Phoolbagan, Kankurgachi, Kolkata, West Bengal 700054 |
|
|
Primary Sponsor
|
| Name |
Apollo Multispeciality Hositals Ltd |
| Address |
58, Canal Circular Road, Kadapara, Phoolbagan, Kankurgachi, Kolkata, West Bengal 700054 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Anirban Mandal |
Apollo Multispeciality Hospitals Ltd. |
Department of Anaesthesiology, Main Block, 1st floor OT Complex.
58, Canal Circular Rd, Kadapara, Phool Bagan, Kankurgachi, Kolkata 700054
Kolkata
WEST BENGAL |
7029625340
anirban1010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Apollo Multispeciality Hospitals Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z940||Kidney transplant status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
NIL |
| Intervention |
Not Applicable |
Not aplicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a. Patient visiting the Nephrology and renal Transplant Unit of Apollo Multispeciality Hospitals Limited.
b. Patients undergoing renal transplantation.
c. Patients from 18 years to 75 years of age group of either sex will be included.
d. The patients/patients’ caregivers who will give the written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
a. Renal Transplant recipients with Significant Cardiac disease (Ejection Fraction (EF) less than 40 percent)
b. Renal disease with a significant potential for recurrence and early kidney graft loss.
c. Patients of age less than 18 years and greater than 75 years will be excluded.
d. The patients/patients caregivers who will not give the written consent to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| i. To determine intra-op hemodynamic [Heart Rate (HR), Mean Arterial pressure (MAP), Pulse pressure variation (PPV)] stability by observing every 10 minutes and recovery time, which is the time to awakening at the end of surgery. |
2 hours 40 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. To determine post-operative Haemodynamics, Urine Output, O2 requirement & Sensorium for 48 hours
ii. To determine Magnesium (Mg), Calcium (Ca) & Trajectory for Creatinine from 48 hours till 7 days |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
24/06/2024 |
| 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="2"
Months="0"
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
|
An observational study will be done to determine the haemodynamic stability and renal outcomes in patients undergoing renal transplantation dividing them into two groups. One group will undergo Bispectral index (BIS) monitored Propofol based total intravenous anaesthesia (TIVA) technique and the other group will undergo Minimum alveolar concentration (MAC) monitored Sevoflurane based inhalational anaesthesia technique. |