| CTRI Number |
CTRI/2022/01/039572 [Registered on: 19/01/2022] Trial Registered Prospectively |
| Last Modified On: |
27/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparitive study between two class of anti-hypertensives on intraoperative hemodynamics and surgical conditions during polypectomy surgery |
|
Scientific Title of Study
|
A comparison of Effect of oral pre-medication with Clonidine and Metoprolol on intraoperative hemodynamics and surgical conditions during functional endoscopic sinus surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swadika N |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variayar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variayar Medical College and Hospitals, Seeragapadi, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9952348249 |
| Fax |
|
| Email |
swadika3895@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shanu S |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka Missions Kirupananda Variayar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variayar Medical College and Hospitals, Seeragapadi, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8056603011 |
| Fax |
|
| Email |
shanushanmugasundaram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swadika N |
| Designation |
Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variayar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variayar Medical College and Hospitals, Seeragapadi, Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9952348249 |
| Fax |
|
| Email |
swadika3895@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Kirupananda Variayar Medical College and Hospitals |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Kirupananda Variayar Medical College and Hospitals |
| Address |
Vinayaka Missions Kirupananda Variayar Medical College and Hospitals Seeragapadi Salem |
| 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 |
| Swadika |
Vinayaka Missions Kirupananda Variayar Medical College and Hospitals |
Department of Anesthesia
Seeragapadi
Salem
Salem
TAMIL NADU |
9952348249
swadika3895@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
| Intervention |
Tablet Clonidine 300 μg |
Clonidine is an α₂-adrenergic agonist medication used to treat high blood pressure, attention deficit hyperactivity disorder, drug withdrawal, menopausal flushing, diarrhea, spasticity and certain pain conditions. It is given once per orally two hours before surgery. |
| Comparator Agent |
Tablet Metoprolol 50 mg |
Metoprolol is a selective β₠receptor blocker medication. It is used to treat high blood pressure, chest pain due to poor blood flow to the heart, and a number of conditions involving an abnormally fast heart rate. It is given once per orally two hours before surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing general anaesthesia
2. ASA Grading I, II
|
|
| ExclusionCriteria |
| Details |
1. ASA 3 and ASA 4
2. Age <18 and >60 years
3. History of hypertension
4. History of asthma
5. Patients already on beta blockers or clonidine
6. Contraindication to general anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
estimate the quality of the operative field and to grade according to the Average Category Scale (ACS) proposed by Fromm and Boezaart.
Surgical field was graded as
Good - ACS 0 or 1
Fair - ACS 2 or 3
Poor –ACS 4 or 5
|
3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood loss intra operatively |
3 hours |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Functional
endoscopic sinus surgery (FESS) has been a major advancement in the management
of a chronic sinusitis and other sino-nasal diseases.Establishing a near
perfect surgical field during functional endoscopic sinus surgery (FESS) is
essential.Minor bleeding can severely compromise an already restricted view obtained
through Hopkin’s rigid nasal endoscope.If controlled hypotension can be provided without compromising the
safety of patient by a relatively effortless method, surgical field can be
improved greatly. Hence, we aim to compare the hemodynamic changes and surgical
conditions during FESS following oral premedication with clonidine or
metoprolol in this study. |