| CTRI Number |
CTRI/2025/03/081643 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Between Metaprolol and clonidine in fess surgery for Hypotensive Anaethesia |
|
Scientific Title of Study
|
Comparative evaluation of oral metaprolol vs oral clonidine as premedication in induced controlled hypotensive anaesthesia for patients undergoing functional endoscopic sinus surgery under general anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalpana devi |
| Designation |
Junior resident |
| Affiliation |
Esic medical College and hospital Chennai |
| Address |
308,ESIC Girls Hostel,Department Of Anaesthesia,ESIC Medical College And Hospital
Chennai
TAMIL NADU
600078
India |
| Phone |
9952602505 |
| Fax |
|
| Email |
drkalpana1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Illango Ganesan |
| Designation |
Professor |
| Affiliation |
Esic medical College and hospital Chennai |
| Address |
210,ESIC Mens Hostel,Department of Anaesthesia,ESIC Medical College and Hospital
Chennai
TAMIL NADU
600078
India |
| Phone |
9884149429 |
| Fax |
|
| Email |
gilang@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana devi |
| Designation |
Junior resident |
| Affiliation |
Esic medical College and hospital Chennai |
| Address |
308,ESIC Girls Hostel,Department of Anaethesia,ESIC Medical College and Hospital
Pondicherry
PONDICHERRY
605110
India |
| Phone |
9952602505 |
| Fax |
|
| Email |
drkalpana1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital,KK Nagar,Chennai-600078 |
|
|
Primary Sponsor
|
| Name |
Dr Kalpana devi |
| Address |
ESIC Medical College And Hospital,KK Nagar,Chennai-600078 |
| Type of Sponsor |
Research institution |
|
|
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 S Kalpana Devi |
ESIC Medical College and Hospital |
ESIC Girls Hostel,Department Of Anaethesia
Chennai
TAMIL NADU |
9952602505
drkalpana1989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe ESIC Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparative evaluation of oral metaprolol vs oral clonidine |
clonidine 2mcg/kg given Orally to one group of patients 1 hour before surgery and Metaprolol 50mg given Orally to one Group 1 hour before Surgery |
| Intervention |
Drug
(Clonidine- 2mcg/kg,
Metaprolol-50mg) |
clonidine 2mcg/kg given Orally to one group of patients 1 hour before surgery and Metaprolol 50mg given Orally to one Group 1 hour before Surgery |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA I & II.
Patients between ages 16 to 60.
Patients undergoing FESS procedure.
|
|
| ExclusionCriteria |
| Details |
Hypertensive patients.
Patients who are not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Metaprolol gives a favourable profile when compare to clonidine |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Metaprolol gives a favourable profile when compare to clonidine |
4 Weeks |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="0"
Days="10" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drkalpana1989@gmail.com].
- For how long will this data be available start date provided 24-04-2024 and end date provided 23-04-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Anaesthesia for Functional endoscopic sinus surgery is a challenging job. The surgeons’ operating field itself is very small and surrounded with mucus membranes. It is imperative for the surgeons to look at a clear surgical field in order to identify the diseased tissue properly. A small amount of blood within the field is enough to occlude the view through the endoscope making things difficult for the surgeon, and incomplete removal of the diseased tissue will cause the disease to reoccur. Anaesthesiologists have devised various techniques to prevent this bleeding, of which induced hypotension has stood the test of time. This surgery per se is not a major one by its standards and surgeons recently have been trying to accomplish FESS as a daycare surgery. A good premedication with an antihypertensive agent can help to minimize the amount of volatile agents and vasodilators used to induce hypotension, thereby ensuring much hemodynamic stability and speedy recovery from anaesthesia. Thus I have chosen to study and compare the effects of clonidine and metoprolol as oral premedicants for the same. This study proposes to analyze the anaesthetic challenge of keeping the operating field free of blood through pharmacological therapy. It compares how premedicating with either atenolol or clonidine affects the conduct of the fixed anaesthesia protocol evolved in our institute on patients undergoing FESS procedure under GA, and requiring a hypotensive technique to improve operating conditions. |