| CTRI Number |
CTRI/2024/05/068035 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between intravenous dexmedetomidine and magnesium sulphate in producing hypotensive anesthesia in patients undergoing Functional endoscopic sinus surgeries |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy between intravenous Dexmedetomidine and Magnesium sulphate for controlled hypotension during Functional Endoscopic Sinus Surgery: A randomized double blinded controlled trial |
| 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 senthil bharath s |
| Designation |
1st year post graduate |
| Affiliation |
AARUPADAI VEEDU MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of anaesthesiology
first floor A block aarupadai veedu medical college and hospital kirumambakkam
aarupadai veedu medical college and hospital kirumambakkam
PONDICHERRY - 607402
INDIA
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8098908559 |
| Fax |
|
| Email |
senthilbharathdrssb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr v haribabu |
| Designation |
professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of anaesthesiology
first floor A block aarupadai veedu medical college and hospital kirumambakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9442369647 |
| Fax |
|
| Email |
haribabu.veeraraghavan@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr C rajesh prabhu |
| Designation |
Associate professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of anaesthesiology
first floor A block aarupadai veedu medical college and hospital kirumambakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9843360106 |
| Fax |
|
| Email |
cr.prabhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology first floor A block aarupadai veedu medical college and hospital kirumambakkam
pondicherry - 607402
INDIA |
|
|
Primary Sponsor
|
| Name |
Arupadai veedu medical college and hospital |
| Address |
Department of anaesthesiology first floor A block aarupadai veedu medical college and hospital kirumambakkam pondicherry |
| 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 |
| Dr senthil bharath s |
Aarupadai veedu medical college and hospital |
Department of anaesthesiology
first floor aarupadai veedu medical cololege and hospital kirumambakkam
Pondicherry
PONDICHERRY |
8098908559
senthilbharathdrssb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee aarupadai veedu medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J329||Chronic sinusitis, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DEXMEDETOMIDINE |
1mcg per kg dexmedetomidine in 100 ml saline solution as the loading dose 10 min before induction and 0.2 mcg per kg per hr infusion via syringe pump during FESS surgery. |
| Intervention |
HYPOTENSIVE ANAESTHESIA |
comparing and evaluate the efficacy of two drugs in producing hypotensive anaesthesia for patient undergoing FESS surgeries |
| Comparator Agent |
MAGNESIUM SULPHATE |
30 mg per kg magnesium sulphate in 100 ml saline solution as the loading dose 10 min before induction and 10-15 mg per kg per hr infusion via syringe pump during FESS surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA-physical status I and II.
patients undergoing Functional Endoscopic Sinus Surgeries. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Patients with severe cardiac hepatic renal disease.
Patients with a history of drug allergy to the study drugs.
Patients with hemodynamic instability.
Patients with coagulopathies.
Pregnant patients.
Patients with autonomic dysfunction.
Patients on magnesium supplementation.
Patients with electrolyte abnormality.
Patients with Anti-arrhythmic drugs & Anti-hypertensive drugs. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Dexmedetomidine vs Magnesium sulphate in providing controlled hypotension during Functional Endoscopic Sinus Surgeries. By means of monitoring MAP mean arterial pressure throughout the procedure. |
2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the level of bleeding during procedure Boezaart & Van der merwe score.
|
2 hours |
| To assess the surgeons satisfaction during procedure Likert score |
2 hours |
| To assess the level of sedation of the patient post operatively Ramsay Sedation Score. |
2 hours |
| Time of Requirement of 1st rescue analgesia VAS score. |
2 hours |
| Time to reach adequate Modified Aldrete score |
20 minutes |
| Clinical signs related to study drugs |
2 hours |
|
|
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)
|
15/06/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Endoscopic sinus surgeries are the most proposed procedure for patients with chronic Rhinosinusitis. Due to the nature of the site involved in surgery, a small amount of bleeding can cause negative effect on the procedure by affecting the proper visualization of the surgical field causing difficulty in doing surgery & prolonged duration of the surgery. So controlled hypotension will help in proper visualization of surgical field and minimize the blood loss. so we are comparing dexmedetomidine and magnesium sulphate in producing controlled hypotension. |