| CTRI Number |
CTRI/2024/11/077112 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing fentanyl and dexmedetomidine for easier and safer wake-up after surgery |
|
Scientific Title of Study
|
A study comparing effects of fentanil vs dexmedetomidine for smooth and efficient extubation |
| 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 Vadde naveen chandra |
| Designation |
Post graduate resident |
| Affiliation |
Varun arjun medical college and rohilkhand hospital |
| Address |
Department of anaesthesia, varun arjun medical college and rohilkhand hospital, banthara district, shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8919744982 |
| Fax |
|
| Email |
Vaddenaveen8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev tiwari |
| Designation |
Professor |
| Affiliation |
Varun Arjun medical college and rohilkhand hospital |
| Address |
Department of anaesthesia, varun arjun medical college and rohilkhand hospital, banthara district, Shahjahanpur.
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7839310269 |
| Fax |
|
| Email |
Rajeev.smch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr amit |
| Designation |
Assistant professor |
| Affiliation |
Varun arjun medical college and rohilkhand hospital |
| Address |
Department of anaesthesia, varun arjun medical college and rohilkhand hospital, banthara district, shahjahnpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8475941938 |
| Fax |
|
| Email |
Amit.kmc1979@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun medical college and rohilkhand hospital, banthara, district- Shahjahanpur, Uttar Pradesh, India, 242307 |
|
|
Primary Sponsor
|
| Name |
Dr Vadde Naveen chandra |
| Address |
Room no-45, Department of anaesthesia, varun arjun medical college and rohilkhand hospital, banthara district, Shahjahanpur, Uttar Pradesh, India, 242307 |
| 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 Vadde Naveen Chandra |
Rohilkhand hospital, banthara, Shahjahanpur |
Department of anaesthesia, Varun Arjun medical college
Shahjahanpur
UTTAR PRADESH |
8919744982
vaddenaveen8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, varun arjun medical college & rohilkhand hospital banthara, shahjahnpur, uttar pradesh, 242307 |
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 |
Dexmedetomidine 0.5 mcg/kg |
Patients of both sexes with physical status ASA 1 and ASA2 of age between 18-60 years undergoing different elective surgeries under general anaesthesia |
| Intervention |
Fentanil 1mcg/kg |
Patients of both sexes with physical status ASA 1 and ASA2 of age between 18-60 years undergoing different elective surgeries under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE I& II
Normotensive patients
Age between 18-60 years |
|
| ExclusionCriteria |
| Details |
Unwilling patients
Patients with past h/o Myocardial ischemia, Hypertension, CVA
Individuals experiencing a current upper respiratory tract infection
Patients with anticipated difficult intubation.
Patients having cardiac, pulmonary, hepatic and renal diseases.
Pregnancy.
Patients with ASA GRADE more than III |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impacts of fentanil and dexmedetomidine on heart rate and systolic blood pressure and diastolic blood pressure , mean arterial pressure during extubation |
To evaluate the impacts of fentanil and dexmedetomidine on heart rate and systolic blood pressure and diastolic blood pressure , mean arterial pressure during extubation will be done for 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate quality of extubation & postoperative sedation with fentanil or dexmedetomidine |
To evaluate the impacts of fentanil & dexmedetomidine on heart rate & systolic blood pressure & diastolic blood pressure , mean arterial pressure during extubation for 1 year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/12/2024 |
| 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="8"
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
|
A study comparing effects of fentanil vs dexmedetomidine for smooth and efficient extubation undergoing different elective surgeries under general anaesthesia will be conducted in department of anaesthesia.
Varun Arjun medical college and rohilkhand hospital, banthara, Shahjahanpur, Uttar Pradesh, 242307, focusing on extubation undergoing different elective surgeries under general anaesthesia.
A. This study will involve patients scheduled for elective surgeries requiring general anaesthesia based on specific inclusion and exclusion criteria.
B. Each patient will undergo a thorough medical history review and provide written informed consent.
C. Participants will undergo preoperative and clinical and laboratory assessment.
D. Patients will be admitted one day prior to the surgery.
E. Participants will be randomly allocated into two groups (ns=30)
Group-F will receive 1mcg/kg fentanil.
Group-D will receive 0.5mcg/kg dexmedetomidine
Group-NS will receive 100ml NS
F. This study will evaluate and contrast the impacts of fentanyl and dexmedetomidine data on heart rate and systolic blood pressure and diastolic blood pressure, mean arterial pressure during extubation to compare the the quality of extubation will be collected throughout the study
|