| CTRI Number |
CTRI/2024/11/076646 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to find whether the drug Dexmedetomidine will help in preventing delirium which is a common postoperative mental state change in patients undergoing liver transplant surgery |
|
Scientific Title of Study
|
Dexmedetomidine for the prevention of postoperative delirium in liver transplant recipients : A Randomized control study |
| 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 Manikandan G |
| Designation |
Senior Resident |
| Affiliation |
INSTITUTE OF LIVER AND BILIARY SCIENCES |
| Address |
Room no 1056, Department Of Anesthesiology ,Institute of Liver and Biliary Sciences Hospital , D-1 , vasant Kunj , New Delhi - 110070
South
DELHI
110070
India |
| Phone |
9791601211 |
| Fax |
|
| Email |
gurumurthymanikandan3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udit Dhingra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences Hospital |
| Address |
Room no 1056 ,Department of Anesthesiology , 3rd Floor , Institute of Liver and Biliary Sciences Hospital , D-1 , Vasant Kunj , New Delhi - 110070
South
DELHI
110070
India |
| Phone |
8861987684 |
| Fax |
|
| Email |
uddh1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udit Dhingra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences Hospital |
| Address |
Room no 1056 ,Department of Anesthesiology , 3rd floor , Institute of Liver and Biliary Sciences Hospital , D-1 , Vasant Kunj , New Delhi - 110070
South
DELHI
110070
India |
| Phone |
8861987684 |
| Fax |
|
| Email |
uddh1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute Funding , Institute of Liver and Biliary Sciences Hospital , D-1 , Vasant Kunj , New Delhi, India , Pincode -110070 |
|
|
Primary Sponsor
|
| Name |
Institute of Liver and Biliary Sciences Hospital |
| Address |
Room no 1056 ,Department of Anesthesiology , D-1 , vasant Kunj , New Delhi , India , Pincode - 110070 |
| 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 Manikandan G |
Institute of Liver and Biliary Sciences Hospital |
Room no 1056 ,Department of Anesthesia ,3rd Floor , D-1 , Vasant Kunj , New Delhi, India , Pincode -110070
South
DELHI |
9791601211
gurumurthymanikandan3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institute of liver and biliary sciences hospital , vasant kunj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K703||Alcoholic cirrhosis of liver, (2) ICD-10 Condition: K740||Hepatic fibrosis, (3) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C |
0.9% Normal Saline group – group C (control group ) .
Participants will receive a continuous intravenous infusion of normal saline from induction of Anesthesia until the skin closure is completed for a period of 12 hours
|
| Intervention |
Group D |
Dexmedetomidine treatment group – Group D (study group ).
Participants will receive a continuous intravenous infusion of 0.5 microgram/kg/h of dexmedetomidine from induction of Anesthesia until completion of skin closure ( end of surgery )
for a period of 12 hours
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 -60
Chronic liver disease patient undergoing elective allogenic liver transplantation
Giving informed written consent
|
|
| ExclusionCriteria |
| Details |
Severe circulatory instability
Patients having hepatic encephalopathy on the morning of surgery
Severe renal dysfunction undergoing renal replacement therapy before surgery
Known allergy to the medication
Transplant for acute liver Failure , acute on chronic liver failure
Patients not giving consent
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of postoperative delirium on postoperative days 1 to 7 using CAM-ICU score |
To compare the incidence of postoperative delirium on postoperative days 1 to 7 using CAM-ICU score |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of postoperative cognitive dysfunction on day 7 using Mini Mental State Exam
To compare the mean hemodynamic parameters during the various phases of liver transplant surgery
To compare the mean requirement of vasopressors during these phases
To compare the incidence of early allograft dysfunction on day 7 using Olthoff criteria
|
day before surgery , intraoperative and postoperative days 1 to 7 |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
20/11/2024 |
| 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="1"
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
|
The incidence of delirium after liver transplant varies from 10 to 47 percent . As a potent a2 adrenergic agonist, Dexmedetomidine acts on the locus coeruleus of the brain and stimulates the presynaptic a2- adrenoceptors, thus inhibiting the release of noradrenaline at the sympathetic synapses. The reduction in norepinephrine induces the release of inhibitory neurotransmitters,including g-aminobutyric acid (GABA ) and galanin by the ventrolateral preoptic nucleus. These neurotransmitters further inhibit norepinephrine release by the locus ceruleus and suppress histamine secretion by the tuberomamillary nucleus. Reducing the release of histamine is beneficial to inflammation caused by tissue damage.Dexmedetomidine possesses an anti-inflammatory effect reducing reducing the central sympathetic outflow and surgical stress response. All these findings indicate that the intraoperative use of Dexmedetomidine can reduce the incidence of delirium after surgery.
|