| CTRI Number |
CTRI/2024/01/061781 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Intravenous and Intranasal dexmedetomidine for changes in vitals during laryngoscopy and endotracheal intubation
|
|
Scientific Title of Study
|
Attenuation of Haemodynamic Responses to Laryngoscopy and endotracheal Intubation with Dexmedetomidine: A Comparison between Intravenous and Intranasal Route.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Kanthed |
| Designation |
PG Anaesthesia resident |
| Affiliation |
Peoples medical college, bhopal |
| Address |
1st floor anaesthesia department, room no. 2
Peoples hospital
2nd floor anaesthesia department, room no. 3
Peoples hospital
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9685256111 |
| Fax |
|
| Email |
kanthedrk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sourabh jain |
| Designation |
Associate Professor |
| Affiliation |
Peoples medical college, bhopal |
| Address |
2nd floor anaesthesia department, room no. 2
Peoples hospital
1st floor anaesthesia department, room no. 5
Peoples hospital
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9826306570 |
| Fax |
|
| Email |
dr_sourabhjain@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohan Kanthed |
| Designation |
PG Anaesthesia resident |
| Affiliation |
Peoples medical college, bhopal |
| Address |
1st floor anaesthesia department, room no. 2
Peoples hospital
2nd floor anaesthesia department, room no. 2
Peoples hospital
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9685256111 |
| Fax |
|
| Email |
kanthedrk@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1st floor room no. 1 operation theater Peoples hospital |
|
|
Primary Sponsor
|
| Name |
Peoples medical college bhopal |
| Address |
Pcms campus bhopal |
| 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 |
| Rohan kanthed |
Peoples hospital |
Room number 1 First Floor peoples hospital peoples campus
Bhopal
MADHYA PRADESH |
9685256111
kanthedrk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples college of medical science and research center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intranasal dexmedetomidine |
intranasal dexmedetomidine for laryngoscopy and endotracheal intubation , hemodynamic monitoring for 10 minutes |
| Intervention |
Intravenous dexmedetomidine |
Intravenous dexmedetomidine for Laryngoscopy and endotracheal intubation , hemodynamic monitoring for 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age18years-60years
ASA grade1 and2
Scheduled for Laryngoscopy and endotracheal Intubation |
|
| ExclusionCriteria |
| Details |
Lack of patient’s consent.
Age<18yrsand>60yrs.
ASA grade 3 and more.
Patients with hypersensitivity to any of the drugs used.
Pregnant and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic stable |
15 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analgesic stability |
15 mins |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/01/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After preoxygenation and premedication group 1 will be given intravenous dexmedetomidine 1ug/kg and group 2 will be given intranasal dexmedetomidine 1ug/kg. Both the groups compared for hemodynamic and analgesic stability. |