| CTRI Number |
CTRI/2017/09/009857 [Registered on: 20/09/2017] Trial Registered Prospectively |
| Last Modified On: |
04/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between effect of an analgesic and an antihypertensive on blood pressure and heart rate which are altered due to tracheal intubation. |
|
Scientific Title of Study
|
A comparative study between fentanyl and dexmedetomidine for attenuation of haemodynamic response to laryngoscopy and intubation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ADITYA PAL MAHISWAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIA,
IGIMS ,PATNA, BIHAR
Patna
BIHAR
800014
India |
| Phone |
8962271102 |
| Fax |
|
| Email |
ADITYAMAHISWAR@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
PRAKASH KUMAR DUBEY |
| Designation |
PROFESSOR |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF ANAESTHESIA, IGIMS ,PATNA, BIHAR
Patna
BIHAR
800014
India |
| Phone |
8962271102 |
| Fax |
|
| Email |
PKDUBEY@HOTMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
ADITYA PAL MAHISWAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
|
| Address |
DEPARTMENT OF ANAESTHESIA, IGIMS ,PATNA, BIHAR
Patna
BIHAR
800014
India |
| Phone |
8962271102 |
| Fax |
|
| Email |
ADITYAMAHISWAR@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES.PATNA 800014,INDIA |
|
|
Primary Sponsor
|
| Name |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
SHEIKHPURA, PATNA 800014, INDIA |
| 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 |
| ADITYA PAL MAHISWAR |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
FIRST FLOOR, OT COMPLEX,
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES
Patna
BIHAR |
8962271102
adityamahiswar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| indira gandhi institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
AMERICAN SOCIETY OF ANAESTHESIOLOGY STATUS 1 AND 2, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
0.5MICROGRAM/KG BODY WEIGHT DILUTED UPTO 5ML BY ADDING NORMAL SALINE TO BE ADMINISTERED INTRAVENOUSLY. |
| Comparator Agent |
FENTANYL |
2MICROGRAM/KG BODY WEIGHT DILUTED UPTO 5ML BY ADDING NORMAL SALINE TO BE ADMINISTERED INTRAVENOUSLY. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with ASA physical status 1 and 2.
2.Patients between 18-50 years of age of either sex.
3.Patients with airway of Mallampati grade 1 and 2.
4.Patients willing to participate. |
|
| ExclusionCriteria |
| Details |
1.Patient/s refusal to participate.
2.Patients with pregnency, morbid obesity, full stomach and emergency surgery.
3.Patients with ASA physical status 3 and above.
4.Patients with suspected difficult airway and Mallampati grade 3 and 4.
5.Patients in which duration of laryngoscopy is expected to last more than 25 seconds. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HEART RATE, MEAN ARTERIAL PRESSURE. |
1 MINUTES, 2 MINUTES, 3 MINUTES, 4 MINUTES, 5 MINUTES. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OXYGEN SATURATION
ADVERSE EFFECT |
1 MINUTE, 2 MINUTE, 3 MINUTE, 4 MINUTE, 5 MINUTE |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
16/11/2018 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
APPLIED FOR PUBLICATION OF THE STUDY. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
comparative evaluation between fentanyl and dexmedetomidine for attenuation of haemodynamic response to laryngoscopy and tracheal intubation will be done in 100 patients. |