| CTRI Number |
CTRI/2021/10/037428 [Registered on: 21/10/2021] Trial Registered Prospectively |
| Last Modified On: |
20/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
IV dexmeditomidine prior to intubation |
|
Scientific Title of Study
|
A comparative study between different doses of intravenous Dexmedetomidine in attenuation of pressor response to laryngoscopy and 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 |
Dr Waseema Kabeer |
| Designation |
Resident |
| Affiliation |
Dr.D.Y Patil medical college |
| Address |
Dept of anaesthesiology
Dr. D.Y Patil medical college and hospital,
Sant Tukaram nagar,
Pimpri chinchwad,
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9884028248 |
| Fax |
|
| Email |
waseema040194@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita Joshi |
| Designation |
Professor and HOD |
| Affiliation |
Dr. D.Y Patil medical college and hospital |
| Address |
Dept of anaesthesiology
Dr. D.Y Patil medical college and hospital,
Sant Tukaram nagar,
Pimpri chinchwad,
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822053792 |
| Fax |
|
| Email |
smitajoshi6@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Joshi |
| Designation |
Professor and HOD |
| Affiliation |
Dr. D.Y Patil medical college and hospital |
| Address |
Dept of anaesthesiology
Dr. D.Y Patil medical college and hospital,
Sant Tukaram nagar,
Pimpri chinchwad,
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822053792 |
| Fax |
|
| Email |
smitajoshi6@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy hi-tech OT |
|
|
Primary Sponsor
|
| Name |
Dr Waseema Kabeer |
| Address |
Dr. D.Y Patil medical college and hospital,
Sant Tukaram nagar,
Pimpri chinchwad,
Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Waseema Kabeer |
Dr. DY Patil medical college |
Dept of anaesthesiology, high tech OT
Dr DY Patil medical college and hospital,, Sant Tukaram nagar,Pune
Pune
MAHARASHTRA |
9884028248
waseema040194@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics sub committee Dr DY Patil medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I and II patients |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmeditomidine 0.5mcg |
Intravenous Dexmeditomidine 0.5 mcg/kg in attenuation of pressor responses in laryngoscopy and endotracheal intubation |
| Comparator Agent |
Dexmeditomidine 1mcg |
Intravenous Dexmeditomidine 1mcg/kg in attenuation of pressor responses in laryngoscopy and endotracheal intubation |
| Intervention |
Dexmeditomidine 1mcg and 0.5mcg |
To compare and study the pressor response to laryngoscopy and endotracheal intubation with different doses of IV Dexmeditomidine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18-60 yr of either sex.
2. ASA grade I and grade II.
3. Patients posted for elective surgeries under general anesthesia requiring intubation.
4. Hemodynamically stable patients having all routine investigations within normal limits.
5. Patients who give written informed consent and are willing to be part of the study. |
|
| ExclusionCriteria |
| Details |
1. Patients refusal.
2. Patients with ASA physical status III and more.
3. Patients with any pre-existing cardiovascular disease.
4. Patients with h/o allergy to test drugs.
5. Patients posted for emergency surgeries.
6. Patients with difficult airway.
7. Patients with neurological disorders and muscle diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the attenuation of pressor response to laryngoscopy and endotracheal intubation with IV dexmedetomindine |
PRE SCOPE, AT THE TIME OF SCOPY, 0 MINS, 5 MINS, EVERY 5 MINUTES UPTO 2 HOURS, POST EXTUBATION VAS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the attenuation of pressor responses to laryngoscopy and endotracheal intubation with intravenous Dexmeditomidine 1mcg/kg |
PRE SCOPE, AT THE TIME OF SCOPY, 0 MINS, 5 MINS, EVERY 5 MINUTES UPTO 2 HOURS, POST EXTUBATION VAS |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/11/2021 |
| 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="6"
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
|
It is a randomised,prospective,comparative,double blinded, observational study wherein Two doses of IV dexmeditomidine are compared for the attenuation of hemodynamic pressor response of laryngoscopy and endotracheal intubation before any surgical procedure in the operation theatre. |