| CTRI Number |
CTRI/2025/07/090920 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
13/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study measuring fluid requirement in kidney transplant recipients, if given Ropivacaine vs fentanyl through epidural route |
|
Scientific Title of Study
|
To determine the effect of Epidural ropivacaine vs fentanyl on Intravenous fluid requirement in patients undergoing renal transplant surgery. A randomized controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ANA/ERF/089 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kakumanu Venkata Aadhira |
| Designation |
Junior resident |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anaesthesia, first floor, old building, Nizams Institute of Medical sciences, Panjagutta, Hyderabad, Telangana, India
Hyderabad
TELANGANA
500082
India |
| Phone |
9100878836 |
| Fax |
|
| Email |
aadhira.kakumanu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indira Gurajala |
| Designation |
Professor |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Speciality block Operation theatre, third floor, Speciality block, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, India
Hyderabad
TELANGANA
500082
India |
| Phone |
7729932044 |
| Fax |
|
| Email |
indiradevraj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kakumanu Venkata Aadhira |
| Designation |
Junior resident |
| Affiliation |
Nizams Institute of Medical Sciences |
| Address |
Department of Anaesthesia, first floor, Old building, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, India
Hyderabad
TELANGANA
500082
India |
| Phone |
9100878836 |
| Fax |
|
| Email |
aadhira.kakumanu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences, Panjagutta, Hyderabad, Telangana, India |
|
|
Primary Sponsor
|
| Name |
K V Aadhira |
| Address |
Department of Anaesthesia, first floor, old building, Nizams Institute of Medical sciences, Panjagutta, Hyderabad, Telangana, India 500082 |
| 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 K V Aadhira |
Nizams Institute of Medical Sciences |
Urology OT, 3rd floor, Specialty block Operation theatre,Specialty block
Hyderabad
TELANGANA |
9100878836
aadhira.kakumanu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl |
Fentanyl through epidural catheter, 50 mcg diluted to 5 ml as initial bolus before incision, followed by infusion of 3mcg/ml dilution at 5ml/hr. duration- from surgical incision time to skin closure time |
| Intervention |
Ropivacaine |
0.25% ropivacaine through epidural catheter, 5 ml bolus before incision followed by 5 ml/hr infusion. duration- from surgical incision time to skin closure time |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who have given written and valid consent to participate in study,
2) Age more than 18 years,
3) Patients of either sex,
4) Patients with normal liver function - no jaundice no raised enzymes in lab values and coagulation profile (prothrombin time, activated partial thromboplastin time and INR as per lab values)
5) BMI less than 35 kg per m2,
6) ASA grade of patient 3 or 4 where grade 3 is a patient with severe Systemic disease and grade 4 is a patient with severe Systemic disease that is a constant threat to life. |
|
| ExclusionCriteria |
| Details |
1) Patient refusal,
2) Patients with history of allergy to local anesthetic,
3) Patients undergoing native kidney nephrectomy along with renal transplant
4) CKD patients with cardiomyopathy- hypertrophic or dilated and Heart failure- as defined by Ejection fraction less than 45% and severe breathless at rest and orthopnea
5)Hemodynamically unstable patients with severe hypotension that is baseline BP of less than 90/60 mmHg before surgery,
6) Pregnant patients,
7) Patients with absolute contraindication to epidural catheterization- local site infection in the lumbar region, coagulopathy or bleeding diathesis and severe hypovolemia.
8) Cold Ischemia time more than 16 hours, that is the time from cold perfusate injection after retrieval to reperfusion with recipient blood |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of epidural ropivacaine on Intravenous fluid given intraoperatively as compared with epidural injection of fentanyl. |
From Induction of anesthesia to after extubation of patient in kidney transplant recipients. Total IV fluid given will be calculated and noted. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate the need for vasopressor requirement to maintain haemodynamic targets when administering epidural ropivacaine as compared to epidural fentanyl during renal transplant surgery |
From Induction of anesthesia to the extubation of patient after kidney transplant surgery, the need for vasopressor requirement will be noted. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="0"
Months="10"
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
|
Epidural anesthesia is commonly given during renal transplant surgeries and is proven to be safe and effective in mitigating perioperative pain of the patient. Most commonly used drug for the same is local anesthetics like Bupivacaine and Ropivacaine. But many studies have shown lower thoracic epidurals that are normally placed for abdominal surgeries will cause hypotension when local anesthetic drug is given due to its effect on sympathetic blockade resulting in vasodilation, pooling of blood and drop in blood pressure. This mechanism of action is specific to local anesthetic drugs. However, this can be easily treated by giving bolus of Intravenous crystalloids. This study focuses on comparing this fluid requirement seen in Ropivacaine (less cardiotoxic) as compared to Fentanyl which is an opioid that acts via blocking u receptors (not causing vasodilation). As renal transplant recipients have a narrow margin for euvolemic status, studies that further optimise fluid management strategies will benefit the patients directly and indirectly by contributing to the literature. As there is a gap in literature for whether this fluid requirement is significant in the two drugs, we propose studying this in a controlled environment to evaluate the same. The study participants will be recruited after ethics committee approval and clinical trial registration and blinded and randomized into one of the two groups. Intraoperative IV fluids will be given based on dynamic targets like pulse pressure variation and systolic pressure variation and also central venous pressure, heart rate and mean arterial pressure. Any need for vasopressor requirement will be noted and the total Intravenous fluids given to the patient at end of surgery will be noted. The results from two groups will be statistically analysed to determine if the effect of drug is significantly more. |