| CTRI Number |
CTRI/2020/07/026344 [Registered on: 03/07/2020] Trial Registered Prospectively |
| Last Modified On: |
02/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Observe the effect of drug dexmedetomididne which will be instilled inside trachea, during removal of endotracheal tube after completion of surgery,
in middle ear surgeries, a randomised controlled trial. |
|
Scientific Title of Study
|
Effect of intratracheal dexmedetomididne administration on recovery from general anaesthesia in middle ear surgery: a randomised double-blinded study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshee Yogendra |
| Designation |
Junior Resident |
| Affiliation |
Govt Medical College and Hospital sec 32 Chandigarh |
| Address |
room no 210,old girls hostel, gmch campus, sec 32 chandigarh
house no 208, khasanpur, near raja saheb phatak, behind durga mandir, jaunpur, uttar pradesh, pin 222001
Chandigarh
CHANDIGARH
160047
India |
| Phone |
7837979806 |
| Fax |
|
| Email |
saksheeyogendra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakesh K Anand |
| Designation |
Professor |
| Affiliation |
Govt Medical College and Hospital sec 32 Chandigarh |
| Address |
Department of anaesthesia and intensive care
Govt Medical College and Hospital sec 32 Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakesh K Anand |
| Designation |
Professor |
| Affiliation |
Govt Medical College and Hospital sec 32 Chandigarh |
| Address |
Department of anaesthesia and intensive care
Govt Medical College and Hospital sec 32 Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9646121522 |
| Fax |
|
| Email |
lkanand11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care |
|
|
Primary Sponsor
|
| Name |
department of anaesthesia and intensive care |
| Address |
Department of Anaesthesia and Intensive care
Govt medical college and hospital sec 32 chandigarh |
| 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 |
| Sakshee Yogendra |
Govt Medical College and hospital sec 32 Chandigarh |
Department of anaesthesia and intensive care, D block, 5th floor
Govt Medical College and hospital sec 32 Chandigarh
Chandigarh
CHANDIGARH |
7837979806
saksheeyogendra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H65-H75||Diseases of middle ear and mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intratracheal administration of dexmedetomidine |
Intratracheal administration of dexmedetomidine on recovery from general anaesthesia in patients undergoing middle ear surgery |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age between 18-60 years.
2. American Society of Anaesthesiologists (ASA) physical status I-II.
3. Patients undergoing elective middle ear surgery requiring endotracheal intubation under GA.
|
|
| ExclusionCriteria |
| Details |
1. Morbid obesity (BMI > 35 kg.m-2).
2. Patients who require rapid sequence induction/ with airway obstruction/ difficult airway
3. Patients with severe cardiovascular, respiratory, hepatic or renal insufficiency.
4. Patients on long-term use of sedative drugs, such as benzodiazepines, barbiturates and other sedative hypnotics.
5. Patient with known allergy to dexmedetomidine.
6. Pregnant women
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) To compare coughing during recovery from general anaesthesia as a primary outcome |
coughing score at 5 min before anaesthesia (T0), immediately after the administration of dexmedetomidine (T1), 5 min after the administration of dexmedetomidine (T2), 10 min after the administration of dexmedetomidine (T3), at the end of surgery (T4), at the point of awareness (T5), at the point of extubation (T6), 2 min after extubation (T7), 5 min after extubation (T8), 15 min after extubation (T9) and 30 min after extubation (T10). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2) To compare hemodynamic parameters, sedation and pain as secondary outcomes and complication if any |
Hemodynamic parameters such as SBP, DBP, MBP and HR values will be recorded 5 min before anaesthesia (T0), immediately after the administration of dexmedetomidine (T1), 5 min after the administration of dexmedetomidine (T2), 10 min after the administration of dexmedetomidine (T3), at the end of surgery (T4), at the point of awareness (T5), at the point of extubation (T6), 2 min after extubation (T7), 5 min after extubation (T8), 15 min after extubation (T9) and 30 min after extubation (T10). |
|
|
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)
|
03/07/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The main aim of the study is to observe the effect of intratracheal administration of dexmedeomidine on recovery from general anaesthesia in patients undergoing middle ear surgery. reduction in coughing response on extubation is observed as primary outcome. Any change in hemodynamic parameters are also noted. The patients undergoing middle ear surgery are recruited under this study. |