| CTRI Number |
CTRI/2026/01/100548 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Propofol Infusion Models to Control Anesthesia Depth in Kidney Transplant Patients |
|
Scientific Title of Study
|
Target controlled infusion of propofol: A comparison of two pharmacokinetic models in patients with end stage kidney disease undergoing kidney transplant surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIPIN KUMAR GOYAL |
| Designation |
Professor and Head |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Organ Transplant anaesthesia and Critical Care,
Mahatma Gandhi Medical college & Hospital, Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
8290342890 |
| Fax |
|
| Email |
dr.vipin28@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
VIPIN KUMAR GOYAL |
| Designation |
Professor and Head |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Organ Transplant anaesthesia and Critical Care,
Mahatma Gandhi Medical college & Hospital, Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
8290342890 |
| Fax |
|
| Email |
dr.vipin28@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
VIPIN KUMAR GOYAL |
| Designation |
Professor and Head |
| Affiliation |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Organ Transplant anaesthesia and Critical Care,
Mahatma Gandhi Medical college & Hospital, Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
8290342890 |
| Fax |
|
| Email |
dr.vipin28@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Hospital |
| Address |
Department of Organ Transplant anaesthesia and Critical Care
Mahatma Gandhi Medical college and Hospital Jaipur Rajasthan 302022 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vipin Kumar Goyal |
Mahatma Gandhi Medical College and Hospital |
Department of Organ Transplant anaesthesia and Critical Care
Mahatma Gandhi Medical college and Hospital Jaipur Jaipur RAJASTHAN |
8290342890
dr.vipin28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Propofol Target controlled infusion (TCI) models |
TCI models- Schnider and Marsh |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with end stage kidney disease scheduled for kidney transplantation under general anesthesia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to see the effect of TCI model on induction of anaesthesia |
induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes are to observe anaesthesia recovery characteristics and any adverse events (hypotension, bradycardia, etc.) |
during surgery |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2026 |
| 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="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
|
This study will be conducted after obtaining ethics committee approval and
signed informed consent. We will enroll
60 patients with end stage kidney disease scheduled for kidney transplantation under
general anesthesia. Exclusion criteria will be age less than 20 years and more
than 60 years, obesity (BMI >30 kg/m2), severe cardiac or
respiratory disease, allergy to any components of propofol. Patients will be
divided into two groups of 30 patients each and will be randomized in any group
based on computer generated table of random numbers. Patients in group M will
receive propofol infusion by modified Marsh model and in group S will receive
by Schinder model of target-controlled infusion (TCI). Propofol will be infused
with Mindray TCI pump in both the groups. On
arrival in the operating room, an intravenous cannula will be secured into a
peripheral vein of non-fistula arm. Routine monitoring including ECG,
non-invasive blood pressure, pulse oximetry and BIS monitor will be attached,
and baseline hemodynamic parameters will be recorded. Intravenous midazolam 1
mg and fentanyl 3 µg/kg will be given to all patients 2 minutes before the
start of propofol infusion. Propofol TCI pump will be connected to the
intravenous canula with running IV fluid. The effect site target of propofol will
be set at 4 µg/ml and will be increased by 0.5 µg/ml every 30 seconds until
there is loss of responsiveness to verbal command in both the groups. Loss of
responsiveness will be checked by other anaesthesiologist who will be blinded
to the research protocol. The anaesthesiologist will check for loss of
responsiveness every 10 s after starting the propofol infusion. Loss of
responsiveness will be defined as lack of response to the verbal command to
open the eyes without touching the patient. Calculated effect-site
concentration of propofol and BIS will be recorded when there is loss of responsiveness.
In both groups, after loss of responsiveness trachea will be intubated on
achievement of train of four response 0 after intubating dose of cisatracurium (2
mg/kg). After tracheal intubation effect site concentration of propofol will be
set at 2.5 µg/ml to maintain BIS between 40-60 throughout the surgery. Infusion
rate of propofol will be adjusted if BIS value is > 60 or < 40 for 1
minute by increasing or decreasing the target effect site concentration by 0.5
µg/ml in both group. Propofol infusion will be stopped on start of closure of
surgical wound. Effect site
concentration of propofol on start of wound closure, BIS and time to return of
responsiveness, duration of BIS < 40 and > 60, and total propofol
consumption will be recorded. Mean arterial pressure and heart rate will be
recorded at baseline, at loss of responsiveness, just after intubation and at
return of responsiveness. Hypotension will be defined if MAP is less than 70
mmHg before reperfusion and less than 90 mmHg after reperfusion and bradycardia
will be defined if HR goes below 60/minutes.
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