| CTRI Number |
CTRI/2020/11/028886 [Registered on: 04/11/2020] Trial Registered Prospectively |
| Last Modified On: |
02/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effects of intratracheal dexmedetomidine on quality of recovery after surgery under general anaesthesia
|
|
Scientific Title of Study
|
Comparison of two doses of intratracheal dexmedetomidine on quality of extubation after surgery under general anaesthesia with endotracheal intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrGopinath V |
| Designation |
M.D postgraduate |
| Affiliation |
Chettinad academy of research and education |
| Address |
Chettinad hospital and research institute, department of anaesthesiology,Rajiv Gandhi salai, kanchipuram district - 603103.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9597396262 |
| Fax |
|
| Email |
gopinath89v@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Lailu mathews |
| Designation |
Head Of The Department |
| Affiliation |
Chettinad academy of research and education |
| Address |
Chettinad hospital and research institute, department of anaesthesiology,Rajiv Gandhi salai, kanchipuram district - 603103.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
|
| Fax |
|
| Email |
lailu.mathews@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGopinath V |
| Designation |
M.D postgraduate |
| Affiliation |
Chettinad academy of research and education |
| Address |
Chettinad hospital and research institute, department of anaesthesiology,Rajiv Gandhi salai, kanchipuram district - 603103.
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9597396262 |
| Fax |
|
| Email |
gopinath89v@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital And Research Institute |
|
|
Primary Sponsor
|
| Name |
Chettinad Hospital and Research Institute |
| Address |
Chettinad hospital and research institute, department of anaesthesiology,Rajiv Gandhi salai, kanchipuram district - 603103. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gopinath V |
Chettinad hospital and research institute |
First Floor,Department of anaesthesiology, Rajiv Gandhi salai, Padur , kanchipuram district -603013
Kancheepuram
TAMIL NADU |
9597396262
gopinath89v@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional human ethics committee |
Approved |
| Institutional human ethics Committee |
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 |
| Intervention |
Comparison of two doses of intratracheal dexmedetomidine |
Dexmedetomidine 0.3mcg/kg |
| Comparator Agent |
Comparison of two doses of intratracheal dexmedetomidine |
Dexmedetomidine- 0.5mcg/kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologist grade I and II
Age 18-65 years
Surgeries under general anaesthesia
BMI <35 |
|
| ExclusionCriteria |
| Details |
Respiratory disease
Heart disorders
Hepatic and renalinsufficiency
Long term use of sedative drugs ( benzodiazepines,barbiturates)
Difficult intubations |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Extubation after surgery under general anaesthesia based on Cough reflex |
30minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative Sedation
Hemodynamic variables |
5 Hours |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
10/11/2020 |
| 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="2"
Months="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
COMPARISON OF TWO DOSES OF INTRATRACHEAL DEXMEDETOMIDINE ON QUALITY OF EXTUBATION AFTER SURGERY UNDER GENERAL ANAESTHESIA WITH ENDOTRACHEAL INTUBATION |