| CTRI Number |
CTRI/2020/06/026186 [Registered on: 26/06/2020] Trial Registered Prospectively |
| Last Modified On: |
25/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study hypotensive properties of dexmedetomidine versus
clonidine for induced hypotension in patients undergoing functional endoscopic sinus surgeries. |
|
Scientific Title of Study
|
Comparison of hypotensive properties of dexmedetomidine versus clonidine for induced hypotension during functional endoscopic sinus surgery : A randomized double blind interventional study at SMS Medical College, Jaipur during 2019-2021 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Usha Bafna |
| Designation |
Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
|
| Fax |
|
| Email |
bafnausha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Sharma |
| Designation |
PG Student |
| Affiliation |
SMS Medical College and attached group of hospitals |
| Address |
Department of Anaesthesia, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7023505643 |
| Fax |
|
| Email |
prshrm585@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Sharma |
| Designation |
PG Student |
| Affiliation |
SMS Medical College and attached group of hospitals |
| Address |
Department of Anaesthesia, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
7023505643 |
| Fax |
|
| Email |
prshrm585@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, SMS Medical College, Jaipur, Rajasthan pincode-302004 |
|
|
Primary Sponsor
|
| Name |
Department of anaesthesiology SMS Medical College |
| Address |
JLN Marg,Jaipur, Rajasthan
Pincode-302004 |
| 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 |
| Dr Usha Bafna |
SMS Hospital and attached group of hospitals, Jaipur |
Department of Anaesthesia, second floor, dhanwantri building SMS Medical College, Jaipur
Jaipur
RAJASTHAN |
9413901579
bafnausha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College, Ethics Committee, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonidine |
Loading dose-2 mcg/kg intravenous
Infusion dose- 1mcg/kg/hr intravenous
Duration of surgery 60-70 minutes
|
| Intervention |
Dexmedetomidine |
Loading dose- 1mcg/kg intravenous
Infusion dose-1mcg/kg/hr intravenous
Duration of surgery 60-70 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade 1 and 2
2.Body weight 45 to 65 kg
3.Undergoing elective resection of nasal polyps ( duration 60 to 70 minutes) |
|
| ExclusionCriteria |
| Details |
1.History of allergy to drugs
2.Preexisting bleeding or coagulation disorders
3.History of hypertension, CAD, hepatic or renal disorder
4.Lack of consent
5.CSF Leak |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the haemodynamic parameters like heart rate, systolic blood pressure,diastolic blood pressure and mean arterial blood pressurefrom base line at different time intervals in both the groups. |
To assess and compare the haemodynamic parameters like heart rate, systolic blood pressure,diastolic blood pressure and mean arterial blood pressurefrom base line at different time intervals in both the groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess and compare the quality of intra operative surgical field in both the groups.
2.To assess and compare emergence time, sedation score,VAS scoreand time to first rescue analgesia demand in post operative period.
3.To find out and compare the proportion of cases with complications. |
Assessment of intraoperative bleeding at 10mins,20mins,30mins,40mins,
50mins,60mins,70mins
|
1. To assess and compare the quality of intra operative surgical field in both the groups.
2.To assess and compare emergence time, sedation score,VAS scoreand time to first rescue analgesia demand in post operative period.
3.To find out and compare the proportion of cases with complications. |
Assessment of intraoperative bleeding at 10mins,20mins,30mins,40mins,
50mins,60mins,70mins
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/06/2020 |
| 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="0"
Months="3"
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
|
In this study we aim to compare the hypotensive properties of dexmedetomidine versus clonidine for induced hypotension during functional endoscopic sinus surgery. |