| CTRI Number |
CTRI/2019/03/018028 [Registered on: 12/03/2019] Trial Registered Prospectively |
| Last Modified On: |
10/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefit OF using two different type of drugs during operation. |
|
Scientific Title of Study
|
A Comparative study of clinical effects and recovery characteristics of intraoperative dexmedetomidine infusion with ketamine vs fentanyl as adjuvant |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mehershree |
| Designation |
junior resident |
| Affiliation |
IMS,BHU,Varanasi |
| Address |
Department Of Anaesthesiology,IMS,BHU,Varanasi
Department Of Anaesthesiology,IMS,BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9956867723 |
| Fax |
|
| Email |
meherlodhi7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A P Singh |
| Designation |
Professor |
| Affiliation |
IMS,BHU,Varanasi |
| Address |
Department Of Anaesthesiology,IMS,BHU,Varanasi
Department Of Anaesthesiology,IMS,BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839412975 |
| Fax |
|
| Email |
bhuapsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mehershree |
| Designation |
Junior resident |
| Affiliation |
IMS,BHU,Varanasi |
| Address |
Department Of Anaesthesiology,IMS,BHU,Varanasi
Department Of Anaesthesiology,IMS,BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9839412975 |
| Fax |
|
| Email |
meherlodhi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences,Banaras Hindu University,Varanasi-221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences |
| Address |
Institute of Medical Sciences,Banaras Hindu University,Varanasi-221005 |
| 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 |
| Mehershree |
IMS |
Department of Anaesthesiology, Institute of Medical Science,BHU
Varanasi
UTTAR PRADESH |
9956867723
meherlodhi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Faculty of Medicine,Institute of Medical Sciences,Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine and ketamine infusion |
Intraoperatively Intravenous Dexmedetomidine 0.5μg/kg/hr in combination with ketamine 0.5mg/kg/hr infusion will be given . |
| Comparator Agent |
Dexmedetomidine and Fentanyl infusion |
Intraoperatively Intravenous Dexmedetomidine 0.5μg/kg/hr in combination with Fentanyl 0.5μg/kg/hr infusion will be given |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I-II
Major Surgeries |
|
| ExclusionCriteria |
| Details |
1-Lack of patients consent
2-ASA Grade III-IV
3-Renal and Hepatic dysfunction
4-Respiratory disorder
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recovery time,hemodynamic vital. |
10,20 min of induction,every 15 min throughout procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time for first analgesic requirements,duration of PACU stay |
2 hourly in postoperative period for 6 hours. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/03/2019 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study will be conducted in ,department of anaesthesiology,IMS ,BHU,VARANASI after written consent and institutional ethical approval.After CTRI registration ,80 patients of ASA grade I and II will be included.They will be randomly allocated to two groups of 40 patients each: DK (Dexmedetomidine & Ketamine) and DF (Dexmedetomidine & Fentanyl) groups. We will monitor extubation time ,recovery time,hemodynamic parameter (e.g.MAP,HR,SPO2 ,RR) and time for first analgesic requirements. |