| CTRI Number |
CTRI/2022/03/041196 [Registered on: 17/03/2022] Trial Registered Prospectively |
| Last Modified On: |
11/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of effectiveness of Alpha2 agonist (Dexmedetomidine) versus opioid (fentanyl) for awake intubation using flexible bronchoscope |
|
Scientific Title of Study
|
A comparative study of safety and effectiveness of Dexmedetomidine versus Fentanyl for awake fiberoptic intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sagana Sekar |
| Designation |
Post Graduate Student |
| Affiliation |
Vinayaka Mission Kirupanada Variyar Medical College and Hospital |
| Address |
Room No 8, First Floor, OT Complex, Department of Anesthesiology, Vinayaka Mission Kirupananda Variyar Medical College and Hospital, Seeragapadi, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
09047010702 |
| Fax |
|
| Email |
dr.saganamahesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabapathy V A |
| Designation |
Professor |
| Affiliation |
Vinayaka Mission Kirupanada Variyar Medical College and Hospital |
| Address |
Room No 8, First Floor, OT Complex, Department of Anesthesiology, Vinayaka Mission Kirupananda Variyar Medical College and Hospital, Seeragapadi, Salem
Room No 8, First Floor, OT Complex, Department of Anesthesiology, Vinayaka Mission Kirupananda Variyar Medical College and Hospital, Seeragapadi, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
09489427563 |
| Fax |
|
| Email |
sabapathyva@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sagana Sekar |
| Designation |
Post Graduate Student |
| Affiliation |
Vinayaka Mission Kirupanada Variyar Medical College and Hospital |
| Address |
Room No 8, First Floor, OT Complex, Department of Anesthesiology, Vinayaka Mission Kirupananda Variyar Medical College and Hospital, Seeragapadi, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
09047010702 |
| Fax |
|
| Email |
dr.saganamahesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions kirupanda variyar medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Vinayaka missions kirupanda variyar medical college and hospital |
| Address |
Seeragapadi, Salem, 636308 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR Sabapathy |
Professor,Department of Anesthesiology,Vinayaka missions kirupanda variyar medical college and hospital,Seeragapadi,Salem , 636308 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sagana S |
Department of Anaesthesiology |
Vinayaka missions kirupanda variyar medical college and hospital,Seeragapadi,636308,
Salem
TAMIL NADU |
9047010702
dr.saganamahesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka missions kirupananda variyar medical college and hospital |
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 |
| Comparator Agent |
Dexmedetomidine 1ug/kd intravenous infusion |
Dexmedetomidine 1ug/kg intravenous infusion given over 10-15minutes |
| Intervention |
Fentanyl 1ug/kg intavenous infusion |
Fentanyl 1ug/kg intavenous infusion given over 10-15minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA-PS grading 1,2
Mallampati grading 1,2 |
|
| ExclusionCriteria |
| Details |
Patient unwilling for the procedure
Age<18 and >50 years
History of bleeding disorder
History of unstable angina
Resting heart rate <50/min
MP 3,4 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Dexmedetomidine(1ug/kg)and Fentanyl (1ug/kg) for sedation and patients comfort and compliance during awake fiberoptic intubation |
Ramsay Sedation score, Cough Score, Post Intubation Score, BP, Heart Rate, Spo2 for 15 minutes intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor complications like respiratory depression, fall in SPO2, bradycardia, hypotension |
baseline, after giving study drugs, post intubation |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
13/06/2022 |
| 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)?
Response - NO
|
|
Brief Summary
|
The study was aimed at comparing the effectiveness and safety of Dexmedetomidine versus Fentanyl for awake fiberoptic intubation. Asample size of 60 patients who fulfill the inclusion criteria was included in the study after getting the informed consent. Patients will be randomly allocated into Group A(Dexmedetomidine), Group B(Fentanyl ) 30 each.Ramsay sedation score ,Cough score, Post intubation score , Vital parameters like Heart rate ,Blood pressure , Oxygen saturation will be assessed preoperatively , After drug infusion , post intubation |