| CTRI Number |
CTRI/2023/05/052754 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of intravenous and nebulised routes of dexmedetomidine as premedication on surgical field visualisation in functional endoscopic sinus surgeries : a randomised control trial |
|
Scientific Title of Study
|
Comparison of intravenous and nebulised dexmedetomidine on surgical field visualisation in functional endoscopic sinus surgeries: a randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemanthkumar |
| Designation |
Postgraduate Resident |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesia and Critical care, AIIMS Bathinda, Bathinda, Punjab, India.
Bathinda
PUNJAB
151001
India |
| Phone |
7845567680 |
| Fax |
|
| Email |
abi.hemanthkumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Gupta |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesia and Critical care, AIIMS Bathinda, Bathinda, Punjab, India.
Bathinda
PUNJAB
151001
India |
| Phone |
8077754166 |
| Fax |
|
| Email |
drm_gupta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemanthkumar |
| Designation |
Postgraduate Resident |
| Affiliation |
All India Institute of Medical Sciences, Bathinda |
| Address |
Department of Anaesthesia and Critical care, AIIMS Bathinda, Bathinda, Punjab, India.
Bathinda
PUNJAB
151001
India |
| Phone |
7845567680 |
| Fax |
|
| Email |
abi.hemanthkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Bathinda |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Bathinda |
| Address |
All India Institute of Medical Sciences, Bathinda, Punjab, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hemanthkumar |
AIIMS Bathinda |
Department od Anaesthesiology and critical care, AIIMS Bathinda, Punjab.
Bathinda
PUNJAB |
7845567680
abi.hemanthkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J33||Nasal polyp, (2) ICD-10 Condition: J31||Chronic rhinitis, nasopharyngitisand pharyngitis, (3) ICD-10 Condition: J32||Chronic sinusitis, (4) ICD-10 Condition: J34||Other and unspecified disorders ofnose and nasal sinuses, (5) ICD-10 Condition: J01||Acute sinusitis, (6) ICD-10 Condition: J30||Vasomotor and allergic rhinitis, (7) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Dexmedetomidine as premedication |
dexmedetomidine at a dose of 1 microgram/ kilogram diluted in 100 ml normal saline once via intravenous route for 15 minutes over infusion prior to induction of anaesthesia
|
| Comparator Agent |
Intravenous Normal saline and Nebulisation with Normal saline |
Intravenous Normal saline 100ml and Nebulisation with normal saline 5 ml as premedication prior to induction of anaesthesia |
| Intervention |
Nebulised Dexmedetomidine as premedication |
dexmedetomidine at a dose of 1 microgram/ kilogram diluted in 5 ml normal saline once via nebulisation route for 15 minutes over infusion prior to induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologists physical status 1 to 2
scheduled for elective functional endosocopic sinus surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent
2. Patient with body mass index ≥ 35 kg/m2.
3. Pregnant patients
4. Patients who are allergic to any study drug
5. Patients with moderate-severe cardiovascular, respiratory, renal or hepatic impairment.
• Patients with anticipated difficult airway
• Patients who are smokers (more than 10 pack-years)
• Patients with bleeding diathesis
• Patients taking any type of BP controlling drugs |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Surgical field visualisation |
till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic changes, post-operative sore throat, post-
operative nausea & vomiting and sedative effect will be observed |
till 24 hours after
the end of the surgery. |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2023 |
| Date of Study Completion (India) |
13/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/03/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, we are comparing the comparing the effect of dexmedetomidine given as a premedication by different routes such as nebulisation and intravenous routes on the surgical field visualisation during functional endoscopic sinus surgeries. although many studies have compared the efficacy of intravenous and nebulised dexmedetomidine separately, we would like to compare both the routes and would like to see which route is as better than the other or if there is no significant difference between two routes.
|