| CTRI Number |
CTRI/2017/06/008885 [Registered on: 20/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
29/05/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study to evaluate the effect of intravenous low dose Dexmedetomidine on blunting haemodynamic responses to laryngoscopy and tracheal intubation in patients undergoing surgery under general anaesthesia |
|
Scientific Title of Study
|
Effect of intravenous low dose Dexmedetomidine on haemodynamic responses to laryngoscopy and tracheal intubation
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahendra Kumar |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences |
| Address |
Department of Anaesthesiology and Critical care
UCMS and GTB hospital
Dilshad garden
New Delhi
UCMS and GTB hospital
Dilshad Garden
New Delhi
110095
East
DELHI
110095
India |
| Phone |
09868399709 |
| Fax |
|
| Email |
mahendramohit@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ragesh I R |
| Designation |
Post Graduate Resident |
| Affiliation |
University College of Medical Sciences |
| Address |
122 A
Pocket A
Dilshad Garden
New Delhi
110095
UCMS and GTB hospital
Dilshad Garden
New Delhi
110095
East
DELHI
110095
India |
| Phone |
9205964745 |
| Fax |
|
| Email |
drrageshir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ragesh I R |
| Designation |
Post Graduate Resident |
| Affiliation |
University College of Medical Sciences |
| Address |
122 A
Pocket A
Dilshad Garden
New Delhi
110095
UCMS and GTB hospital
Dilshad Garden
New Delhi
110095
East
DELHI
110095
India |
| Phone |
9205964745 |
| Fax |
|
| Email |
drrageshir@gmail.com |
|
|
Source of Monetary or Material Support
|
| UCMS and GTB hospital
Dilshad Garden
New Delhi
110095 |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences |
| Address |
UCMS and GTB hospital
Dilshad Garden
New Delhi
110095 |
| 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 |
| Dr Mahendra Kumar |
University College of Medical Sciences and GTB hospital |
Department of Anaesthesiology and Critical Care
Dilshad Garden
New Delhi
110095
East
DELHI |
09868399709
mahendramohit@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Any patients electively posted for general anaesthesia with endotracheal intubation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
0.5 mcg/kg Dexmedetomidine in 100ml Normal Saline over 10 minutes preoperatively |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgery under general anaesthesia with endotracheal intubation
ASA grade 1 patients having Mallampatti grade 1 airway |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
History of cardiovascular, renal, respiratory, endocrine and neuronal disoders
Pregnant and lactating women
Patients taking any drugs affecting haemodynamic parameters. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in Systolic Blood Pressure following laryngoscopy and tracheal intubation in two groups. |
1, 3, 5, 7 and 10 minutes following laryngoscopy and tracheal intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/01/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
SUMMARY
Laryngoscopy and tracheal intubation cause sympathetic stimulation in human body which will be easily tolerated by healthy people. The haemodynamic responses caused by sympathetic stimulation will be significant in unhealthy subjects. So many drugs have been used for studies for blunting those responses like lignocaine, nalbuphine, clonidine etc. Dexmedetomidine is also one of those drugs which have been studied for these purpose by many authors. Effect of the drug in blunting the haemodynamic responses was found to be dose dependant. But in high doses significant incidences of adverse effects was documented.
The cited study is planned as a randomised double blinded controlled study using low dose ( 0.5 mcg/kg ) Dexmedetomidine to blunt the haemodynamic responses to laryngoscopy and tracheal intubation. The drug/placebo will be infused to the patients in 100ml Normal saline , 10 minutes before induction of general anaesthesia. Haemodynamic parameters will be noted in regular intervals perioperatively. The response in haemodynamic parameters will be compared and analysed afterwards by unpaired t test and repeated measures by ANOVA followed by Tukey’s test. Incidence of side effects will be also noted. Qualitative meausres will be analysed by chi square test. P value less than 0.05 will be considered significant |