| CTRI Number |
CTRI/2019/11/021910 [Registered on: 07/11/2019] Trial Registered Prospectively |
| Last Modified On: |
31/08/2021 |
| 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 Dexmedetomidine and Magnesium sulphate for heart rate, blood pressure,intra-operative bleeding in functional endoscopic sinus surgery |
|
Scientific Title of Study
|
A Randomized Double Blind Interventional Study to Compare Hypotensive Properties of Dexmedetomidine Versus Magnesium Sulphate for Induced Hypotension During Functional Endoscopic Sinus Surgery at SMS Medical College Jaipur During 2018-19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jahnu Bhoj Nagal |
| Designation |
Resident Doctor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Anaesthesia,
SMS Medical College and attached hospital
Jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9461472545 |
| Fax |
|
| Email |
nagaljahnu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Bafna |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Anaesthesia
SMS Medical College and attached hospitals
Jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9413901579 |
| Fax |
|
| Email |
priyasingh.pgr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jahnu Bhoj Nagal |
| Designation |
Resident Doctor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Anaesthesia
SMS Medical College and attached hospitals
Jaipur
Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9461472545 |
| Fax |
|
| Email |
nagaljahnu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia SMS medical college Jaipur |
|
|
Primary Sponsor
|
| Name |
SMS Medical College Jaipur |
| Address |
JLN Marg jaipur Rajasthan |
| 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 Jahnu Bhoj Nagal |
SMS hospital Jaipur |
ENT division
Department of Anaesthesia
Jaipur
RAJASTHAN |
9461472545
nagaljahnu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Committe, S.M.S. Medical College and attached hospitals, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J339||Nasal polyp, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
hypotensive anaesthesia during functional endoscopic sinus surgeries |
use of dexmedetomidine versus magnesium sulphate for hypotensive anaesthesia |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
body weight of 45 to 65 kg
ASA grade 1 and 2
undergoing elective resection of nasal polyp (duration 60-70 minutes) |
|
| ExclusionCriteria |
| Details |
history of allergy to these drugs
patients with pre existing bleeding and coagulation abnormalities
history of hypertension, CAD, renal and hepatic dysfunction
cerebral insufficiency
patients not willing to participate in study
orbital abscess
CSF leak with or without CSF rhinorrhea |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| intraoperative SBP, DBP,MAP, HR |
base line
after loading of study drug
after induction
1 min after intubation
5 min after intubation
10 min
20 min
30 min
40 min
50 min
60 min
70 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ASSESMENT OF INTRAOPERATIVE BLEEDING BY SURGEON
EMERGENCE TIME
TIME TO FIRST RESCUE ANALGESIC DEMAND |
EVERY TEN MINUTES |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/11/2019 |
| Date of Study Completion (India) |
21/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
With this background, this study is designed to compare the effectiveness and safety of dexmedetomidine versus magnesium sulphate as a hypotensive agent in functional endoscopic sinus surgery with attention on the quality of surgical field, emergence time, sedation score, VAS score, recovery profile and to evaluate the side effects. |