| CTRI Number |
CTRI/2018/03/012796 [Registered on: 23/03/2018] Trial Registered Prospectively |
| Last Modified On: |
20/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effects of preoperative administartion of dexmedetomidine on the smoothness of removing endotracheal tube at the end of surgery |
|
Scientific Title of Study
|
Dexmedetomidine premedication and quality of extubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammed Faisal M |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Kozhikode |
| Address |
Department of Anaesthesiology, Government Medical College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9747629663 |
| Fax |
|
| Email |
faisalkmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Taznim Mohamed |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Kozhikode |
| Address |
Department of Anaesthesiology, Government Medical College, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9895012092 |
| Fax |
|
| Email |
taznimashraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Taznim Mohamed |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Kozhikode |
| Address |
Department of Anaesthesiology, Government Medical College, Kozhikode
KERALA
673008
India |
| Phone |
9895012092 |
| Fax |
|
| Email |
taznimashraf@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Kozhikode |
|
|
Primary Sponsor
|
| Name |
Government Medical College Kozhikode |
| Address |
Government medical College, Kozhikode, Kerala- 673008 |
| 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 |
| Mohammed Faisal M |
Government Medical College. Kozhikode |
Department of Anaesthesiolgy, Government Medical College, Kozhikode
Kozhikode
KERALA |
9747629663
faisalkmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Medical College, Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Study will be conducted on ASA 1 and 2 patients, aged 20-60yrs undergoing thyroidectomy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
200 ml normal saline (placebo) administered over 20 minutes |
Administered as infusion over a period of 20 minutes starting 20 minutes prior to induction |
| Intervention |
Dexmedetomidine 0.75 microgram/ kg in 200ml normal saline administered over 20 minutes |
Administered as infusion over a period of 20 minutes starting 20 minutes prior to induction. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Study will be conducted on 60 ASA 1 and 2 patients aged 20-60-yrs, weighing 40-70kg,posted for elective thyroid suregeries |
|
| ExclusionCriteria |
| Details |
Patients with sinus bradycardia, heart blocks,coronary artery disease, those on beta blockers and calcium channel blockers are excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of extubation |
1,3,5,10,15,20 and 30 minutes after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Level of consciousness |
1,3,5,10,15,20 and 30 minutes after extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/04/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1)WijeysunderaDN,NaikJS,Beattie WS-Alpha 2 adrenergicagonist to prevent perioperative cardiovascular complications.Ameta-analysis-Am J Med.2003;114:742-52 [pub Med]
2)TalkaP,Chan R, Thomas B,AggarwalA,GottliebA,ThorborgP,etal.The hemodynamic and adrenergic effects ofperioperativedexmeditomidine infusion after vascular surgery.Anesth Analg.2000;90:834-9 [Pub Med]
3)LawrenceCJ,De Lange S, Effect of single preoperative dexmeditomidine dose on isofluranerequirements and perioperative hemodynamic stability.Anesthesia 1997;52:736-44
4)AsaiT,VaughanRS.Respiratory complications associated withtracheal intubation and extubation.Br J Anaes 1998;80:767-775
5)HoffmanBB.Adrenoreceptoractiving and other sympathomimetic drugs. In:katzungB.Basic and clinical Pharmacology.9thed,Newyork,NY:MC Graw-Hill.2003;9:134-139
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Postextubation cough is troublesome and impedes the smoothness of extubation. Dexmedetomidine has significant sympatholytic property and can attenuate the stress response. The study will be conducted on 60 consenting ASA 1 nand 2 patients, aged 20-60-yrs and weighing 40-70kg undergoing elective throidectomy. Those with sinus brady cardia, heart blocks, coronary artery disease, those taking beta blockers and calcium channel blockers will be excluded.The aim of our study is to study the effectiveness of dexmedetomidine on the quality of extubation and level of consciousness, when given as a single bolus infusion, along with premedication, just before induction of general anaesthesia. The study group will receive dexmedetomidine 0.75 microgram/ kg, in 200ml normal saline 20 minutes before induction and control group will receive 200ml of normal saline (placebo) over 20 minutes. The quality of extubation at the end of surgery will be asessed using 5 point extubation score and the level of consciousness using modified Wilson sedation score. The haemodynamic parameters are also noted. Any complications like delayed recovery, undue sedation, airway obstruction, bradycardia, hypo/ hypertension will be noterd and managed apporopriately. |