| CTRI Number |
CTRI/2020/04/024559 [Registered on: 09/04/2020] Trial Registered Prospectively |
| Last Modified On: |
30/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation Of two different drugs With Peripheral Nerve Blocks For Split Skin Grafting From Lower Limbs In Adults |
|
Scientific Title of Study
|
Comparative Evaluation Of Combined Use Of Intravenous Dexmedetomidine-Ketamine With Dexmedetomidine Alone With Peripheral Nerve Blocks For Split Skin Grafting From Lower Limbs In Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudhir kumar |
| Designation |
Post Graduate MD Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjang Hospital |
| Address |
Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjang Hospital, Ansari Nagar,New delhi
South West
DELHI
110029
India |
| Phone |
9717936521 |
| Fax |
|
| Email |
sudhirxaviers@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ameeta Sahni |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjang Hospital |
| Address |
Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjang Hospital, Ansari Nagar, New Delhi
South West
DELHI
110029
India |
| Phone |
9811201585 |
| Fax |
|
| Email |
Ameetaas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudhir kumar |
| Designation |
Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjang Hospital |
| Address |
Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjang Hospital, Ansari Nagar,New Delhi
South West
DELHI
110029
India |
| Phone |
9717936521 |
| Fax |
|
| Email |
sudhirxaviers@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjang Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjang Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjang Hospital, Ansari Nagar , New Delhi |
| 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 |
| Sudhir Kumar |
Vardhman Mahavir Medical College and Safdarjang Hospital |
Department of Anaesthesia and critical care, burns ot , ground floor
South West
DELHI |
9717936521
sudhirxaviers@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjang Hospital Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: X16||Contact with hot heating appliances, radiators and pipes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined use of intravenous Dexmedetomidine-ketamine with Dexmedetomidine alone with peripheral nerve block in two different groups |
Group DK will receive intravenous Dexmedetomidine-ketamine with peripheral nerve block and group D will receive intravenous Dexmedetomidine with peripheral nerve block for sedation-analgesia in adults undergoing split skin grafting from lower limbs |
| Comparator Agent |
Comparative Evaluation Of Combined use of Intravenous Dexmedetomidine-Ketamine with Dexmedetomidine alone with peripheral nerve block for split skin Grafting from lower limbs in adults |
Group DK will receive intravenous Dexmedetomidine and ketamine followed by peripheral nerve block and group D will receive intravenous Dexmedetomidine followed by peripheral nerve block in adults undergoing split skin Grafting from lower limbs and the results compared |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Adults aged between 18-65 years undergoing split skin grafting from anterolateral aspect of thigh in supine position when the area of harvesting/donor site is less than 5 percent
2) ASA grade 1 |
|
| ExclusionCriteria |
| Details |
Patients with co-morbidities like hypertension, diabetes mellitus,sepsis, difficult airway or any other sysyetmic disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the role of combined use of Intravenous Dexmedetomidine-Ketamine with Dexmedetomidine alone with peripheral nerve block for sedation-analgesia in split skin Grafting From Lower Limbs In Adults using Ramsay Sedation Score |
Every 5 minutes vital monitoring intraoperatively and outcome assessment by ramsay sedation score intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the haemodynamic changes Associated with the combined use of intravenous Dexmedetomidine-ketamine with Dexmedetomidine alone for sedation-analgesia in adults |
Peri-operative |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/05/2020 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is an interventional comparative study to find out and compare the role of combined use of intravenous Dexmedetomidine-ketamine with Dexmedetomidine alone with peripheral nerve blocks for sedation-analgesia using Ramsay Sedation Score in adults undergoing split skin grafting from the lower limbs |