| CTRI Number |
CTRI/2020/06/025605 [Registered on: 04/06/2020] Trial Registered Prospectively |
| Last Modified On: |
25/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of the drug dexmedetomidine used during a nasal surgery on the recovery of the patient while coming out of anesthesia |
|
Scientific Title of Study
|
Efficacy of Intraoperative Dexmedetomidine Infusion on Emergence Agitation and Quality of Recovery After Nasal Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sita mukkavilli |
| Designation |
Post graduate |
| Affiliation |
Kasturba Medical College |
| Address |
Department Of Anesthesia Kasturba Medical College
203,Light House Hill Road,Hampankatta,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9949262494 |
| Fax |
|
| Email |
msita90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSunilBV |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College |
| Address |
Department Of Anesthesia
Kasturba Medical College
203,Light House Hill Road,Hampankatta,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9620178559 |
| Fax |
|
| Email |
drsunilbv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sita mukkavilli |
| Designation |
Post graduate |
| Affiliation |
Kasturba Medical College |
| Address |
Department Of Anesthesia
Kasturba Medical College
203,Light House Hill Road,Hampankatta,
Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9949262494 |
| Fax |
|
| Email |
msita90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
203, Light House Hill Road, Hampankatta,Mangaluru
575001 |
|
|
Primary Sponsor
|
| Name |
kasturba medical college |
| Address |
203,light house hill road
hampankatta,mangalore
karnataka 575001 |
| Type of Sponsor |
Private 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 sita |
KMC Hospital |
Department Of Anesthesia
Attavar, Mangalore-575001
Dakshina Kannada
KARNATAKA |
9949262494
msita90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college ,Mangaluru |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
age from 18 to 60 yrs
asa 1-2 class
undergoing elective nasal surgeries |
|
| ExclusionCriteria |
| Details |
known allergy to alpha 2 adrenergic agonist or nsaids
use of MAO inhibitors or adrenergic blocking drugs
history of uncontrolled hypertension
cognitive impairment
chronic use of anti psychotic
kidney or liver disease
bmi greater or equal to 30 kg/metre square |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement In Recovery And Emergence Agitation In Post Nasal Surgery Following Intraoperative Low Dose Dexmedetomidine Infusion |
The patient response is assessed immediately after extubation-at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced Incidence In Post Operative Nausea And Vomiting in addition to smooth recovery |
Assessed approximately upto 2 hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
07/06/2020 |
| 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
|
Low dose Dexmedetomidine infusion will be started intraoperatively for elective nasal surgeries The patient’s recovery from anaesthesia will be assessed Also nausea and vomiting and grade of cough will be assessed |