| CTRI Number |
CTRI/2024/11/076224 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to test a medicine to reduce sore throat following general anaesthesia following prone surgeries |
|
Scientific Title of Study
|
Effect of nebulized dexmedetomidine and saline nebulization for preventing post operative sore throat following general endotracheal anaesthesia for surgery in prone position: a double blinded placebo control 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 Shameem P Shooja |
| Designation |
Junior resident department of anaesthiology pain medicine and critical care ,AIIMS NEW DELHI |
| Affiliation |
Junior resident department of anaesthesia pain medicine and critical care AIIMS NEW DELHI |
| Address |
Department of anaesthiology pain medicine and critical care , AIIMS NEW DELHI
South West
DELHI
110029
India |
| Phone |
9599098289 |
| Fax |
|
| Email |
Spsl222833@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Babita Gupta |
| Designation |
Professor department of anaesthesia pain medicine and critical care AIIMS NEW DELHI |
| Affiliation |
Professor department of anaesthesia pain medicine and critical care,JPNATC,AIIMS NEW DELHI |
| Address |
Department of anaesthesia pain medicine and critical care JPNATC AIIMS New Delhi
South West
DELHI
110029
India |
| Phone |
9818302776 |
| Fax |
|
| Email |
drbabitagupta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shameem P Shooja |
| Designation |
Junior resident acad |
| Affiliation |
Aiims,New Delhi |
| Address |
Department of anaesthiology pain medicine and critical care ,aiims new delhi
South West
DELHI
110029
India |
| Phone |
9599098289 |
| Fax |
|
| Email |
Spsl222833@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology pain medicine and critical care ,aiims New Delhi |
|
|
Primary Sponsor
|
| Name |
Aiims New Delhi |
| Address |
Ansari Nagar,New Delhi,110029 |
| 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 |
| Prof Babita Gupta |
Aiims ,Ansari nagar ,New Delhi ,110029 |
Department of anaesthiology pain medicine and critical care ,room no 5012 ,aiims New Delhi,110029
South West
DELHI |
9818302776
drbabitagupta@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for post graduate research,aiims new delhi |
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 |
Nebulization with dexmedetomidine |
50mcg dexmedetomidine in 4.5ml
0.9% normal saline is administered to the patient through nebulization for 15 mins preoperatively in the pre op room |
| Comparator Agent |
Normal saline nebulization |
5ml 0.9% saline is administered to the patients through nebulization for 15minutes pre operatively in the pre op room |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients aged 18-65 years scheduled
for elective surgery requiring prone position
for surgery under general anaesthesia with
endotracheal intubation
2. ASA (American Society of
Anaesthesiologists) physical status I - II
patients
3. Expected surgical time: Atleast two hours |
|
| ExclusionCriteria |
| Details |
1. Patients with preoperative sore throat or
upper respiratory tract infection
2. Heart rate less than 60per minute SBP less than 90mm Hg
3. Pregnant patients
4. Requiring more than two attempts for the
insertion of an endotracheal tube
5. Use of throat pack
6. Surgery lasting more than three hours or
expected postoperative mechanical
ventilation
7. Use of video laryngoscope for endotracheal
intubation |
|
|
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 |
| Severity of post operative sore throat |
At 6th hour post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative sore throat |
0,2,6,12,24 hrs |
| Significant post operative sore throat |
0,2,6,12,24 hrs |
| Post operative sore throat and hoarseness of voice |
0,2,6,12,24hrs |
|
|
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)
|
20/11/2024 |
| 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="2"
Months="0"
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
|
Postoperative sore throat (POST) is a common complication following general anaesthesia.It causes patient discomfort & dis-satisfaction, potentially delaying their return to regular activities . Changing of position from supine to prone can change ETT cuff pressure & ET tube displacement which may affect the incidence of POST. ET tube displacement occurred in 91.7% of patients after supine-to-prone position change; of these, 48% of patients’ ET tube moved more than 10 mm and ET tube cuff pressure changed in 86.3 percent 0f patients. No study has been conducted to evaluate the effectiveness of dexmedetomidine nebulization in decreasing POST in prone position surgeries. We plan this study to investigate the prophylactic effect of dexmedetomidine nebulization in decreasing POST in patients undergoing surgeries under general anaesthesia with tracheal intubation in prone position. Dexmedetomidine is a potent alpha-2 receptor agonist. It cause sedation, pain alleviation, & diminished sympathetic activity .Local application of nebulized dexmedetomidine yields analgesic and anti-inflammatory effects by lowering postoperative serum levels of IL-6, IL-8, & TNF-α.Dexmedetomidine through nebulization is well tolerated and represents a promising new administration approach that has minimal effects on the cardiovascular and the respiratory systems |