| CTRI Number |
CTRI/2016/04/006844 [Registered on: 19/04/2016] Trial Registered Retrospectively |
| Last Modified On: |
09/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Does fentanyl dexmedetomidine combination attenuate the haemodynamic responses to laryngoscopy and tracheal intubation |
|
Scientific Title of Study
|
Attenuation of haemodynamic responses to laryngoscopy and tracheal intubation-comparison of fentanyl alone and fentanyl dexmedetomidine combination |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAKSHI MAHAJAN |
| Designation |
Post Graduate |
| Affiliation |
lady hardinge medical college |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College, New Delhi
lady hardinge medical college, opposite shivaji stadium, connaught place
New Delhi
DELHI
110092
India |
| Phone |
9654099541 |
| Fax |
|
| Email |
sakshi_mint@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
RADHIKA AGARWALA |
| Designation |
DIRECTOR- PROFFESOR |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College
Central
DELHI
110001
India |
| Phone |
9811702063 |
| Fax |
|
| Email |
radhikaagarwala@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RADHIKA AGARWALA |
| Designation |
DIRECTOR- PROFFESOR |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College
Central
DELHI
110001
India |
| Phone |
9811702063 |
| Fax |
|
| Email |
radhikaagarwala@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College |
|
|
Primary Sponsor
|
| Name |
lady hardinge medical college |
| Address |
lady hardine medical college,opposite shivaji stadium, connaught place |
| 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 |
| Sakshi Mahajan |
Lady Hardinge Medical College |
Department of anaesthesia, Lady Hardinge Medical College,
Central
DELHI |
9654099541
sakshi_mint@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethical committee, Lady Hardinge Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA I , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj fentanyl (2ug/kg) |
100 ml normal saline given over 10 minutes before induction |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA I patients of both sexes posted for elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
patients with known history of allergy to any drug, patients with any systemic disease, emergency surgical procedures, anticipated difficult intubation, patients where intubation was prolonged or required more than one attempt |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| no rise in heart rate & blood pressure was observed after intubation in patients receiving dexmedetomidine & fentanyl |
HR, BP were measured at baseline,immediately after giving study drug, after giving induction agent, before intubation, 1,3, 5 & 10 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/10/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of our study was to study the effect of intravenous fentanyl (2ug/kg) alone and fentanyl (2ug/kg) and dexmedetomidine (1ug/kg) for attenuation of haemodynamicresponses to laryngoscopy and tracheal intubation in patients recieving general anaesthesia. we observed that single dose of IV fentayl (2ug/kg) blunts but does not completely abolish the haemodynamic response to laryngoscopy and tracheal intubation. however, combination of dexmedetomidine ( 1ug/kg) along with fentanyl (2ug/kg) completely abolishes the haemodynamic stress response to llaryngoscopy and tracheal intubation. |