| CTRI Number |
CTRI/2024/09/073834 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare The Efficacy Of Nebulized Dexmedetomidine Versus Normal Saline For Patients Comfort And Satisfaction During Diagnostic Upper Gastrointestinal Endoscopy |
|
Scientific Title of Study
|
Efficacy Of Nebulized Dexmedetomidine For Patients Comfort And Satisfaction During Diagnostic Upper Gastrointestinal Endoscopy |
| 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 Reshma salim |
| Designation |
Junior resident |
| Affiliation |
Dr DY Patil Medical College hospital and research centre,pimpri pune |
| Address |
Department Of Anaesthesiology , 5th Floor Hi-tech Building, DR D Y Patil Medical College Hospital And Research Centre , Sant Tukaram Nagar,Pimpri, Pune,Maharashtra,
411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8547835546 |
| Fax |
|
| Email |
reshmasalim63@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department Of Anaesthesiology |
| Affiliation |
Dr DY Patil Medical College hospital and research centre,pimpri pune |
| Address |
Department Of Anaesthesiology , 5th Floor Hi-tech Building, DR D Y Patil Medical College Hospital And Research Centre , Sant Tukaram Nagar,Pimpri, Pune,Maharashtra,
411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8547835546 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavini Shah |
| Designation |
Professor, Department Of Anaesthesiology |
| Affiliation |
Dr DY Patil Medical College hospital and research centre,pimpri pune |
| Address |
Department Of Anaesthesiology , 5th Floor Hi-tech Building, DR D Y Patil Medical College Hospital And Research Centre , Sant Tukaram Nagar,Pimpri, Pune,Maharashtra,
411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8547835546 |
| Fax |
|
| Email |
drbhavinishah71@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy, 5th Floor Hi-tech Building, DR D Y Patil Medical College Hospital And Research Centre , Sant Tukaram Nagar,Pimpri, Pune,Maharashtra,
411018 |
|
|
Primary Sponsor
|
| Name |
Dr Reshma salim |
| Address |
Department Of Anaesthesiology , 5th Floor Hi-tech Building, DR D Y Patil Medical College Hospital And Research Centre , Sant Tukaram Nagar,Pimpri, Pune,Maharashtra,
411018 |
| Type of Sponsor |
Other [other (self)] |
|
|
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 Reshma Salim |
DR D Y Patil Medical College Hospital And Research Centre |
Department Of Anaesthesiology , 5th Floor Hi-tech Building, Sant Tukaram Nagar,Pimpri, Pune,Maharashtra,
411018
Pune
MAHARASHTRA |
8547835546
reshmasalim63@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee, Dr D Y Patil medical college ,Pune |
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 |
Dexmedetomidate |
nebulised dexmedetomidine 1mcg/kg diluted in normal saline (0.9%) to a volume of 5ml given prior to procedure. |
| Comparator Agent |
Normal saline |
nebulized normal saline (0.9%) 5 ml will be given prior to procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18 to 70 years of either sex
2. American Society of Anaesthesiology (ASA) grade I and II posted for elective diagnostic upper gastrointestinal endoscopy. |
|
| ExclusionCriteria |
| Details |
1) Patients with uncontrolled hypertension/hypotension 2) Psychiatricillness
3) Not willing |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate nebulized dexmedetomidine vs nebulized normal saline for patients comfort and satisfaction during diagnostic upper gastrointestinal endoscopy. |
will be assesed at baseline,post nebulisation,during procedure,post procedure .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stress response to upper gastrointestinal endoscopy
Ease of procedure by endoscopist
Patients comfort & satisfaction
Side effects of study drug if any |
will be assessed during & post procedure on the same day itself of the surgery. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
19/09/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A Prospective comparative study To evaluate nebulized dexmedetomidine versus nebulized normal saline for patients comfort and
satisfaction during diagnostic upper gastrointestinal endoscopy. study also observes : 1) Stress response to upper gastrointestinal endoscopy 2) Ease of procedure by endoscopist 3) Patients comfort and satisfaction 4) Side effects of study drug if any |