| CTRI Number |
CTRI/2020/12/029649 [Registered on: 08/12/2020] Trial Registered Prospectively |
| Last Modified On: |
20/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
what intranasal dexmedetomidine dose is better in sedation : 2mcg/kg or 3mcg/kg? |
|
Scientific Title of Study
|
Comparison of two different doses of intranasal dexmedetomidine for pediatric procedural sedation: a prospective study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suresh Nagalikar |
| Designation |
Postgraduate junior resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Anaesthesia,pain and critical care
AIIMS Tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9482289473 |
| Fax |
|
| Email |
sureshnagalikar1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samarjit Dey |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of anaesthesia
AIIMS Tatibandh, Raipur Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
8014910806 |
| Fax |
|
| Email |
drsamar0002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suresh Nagalikar |
| Designation |
Postgraduate junior resident |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Anaesthesia,pain and critical care
AIIMS Tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
9482289473 |
| Fax |
|
| Email |
sureshnagalikar1@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raipur |
| Address |
AIIMS
Tatibandh 492099
Raipur Chhattisgarh |
| 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 Suresh |
All India Institute of Medical Sciences Raipur |
Radiology Pre-procedure area basement B block.
AIIMS campus, Tatibandh Raipur
492099
Raipur
CHHATTISGARH |
9482289473
sureshnagalikar1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTE |
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 |
There are two intervention arms, intranasal dexmedetomidine 3mcg/kg and intranasal dexmedetomidine 2mcg/kg. |
Duration approximate 2 hours |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
pediatric patients aged between 1 years and 10 years who are undergoing non-invasive radiological procedures like CT scan, MRI, Ultrasound, echocardiography. Belonging to ASA PS grade 1 and 2. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Research Hypothesis: Intranasal Dexmedetomidine 3mcg/kg is more efficient than intranasal dexmedetomidine 2mcg/kg for non-invasive radiological procedural sedation in pediatric age group. Greater efficacy will be established based on sedation level and need of rescue doses of drug. |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
we assume that, physician’s satisfaction in performing the procedure is better with 3mcg/kg body weight
safety profile of 3mcg/kg body weight dose of Intranasal dexmedetomidine in terms of adverse events (bradycardia, hypotension, desaturation, excessive sedation) is better.
|
8 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2021 |
| Date of Study Completion (India) |
18/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The importance of
procedural sedation and analgesia (PSA) for children undergoing diagnostic procedures
such as imaging studies in CT, MRI suite and for echocardiography has led to an
increase in demand for sedation outside of the operating room. Due to this
demand, the role of pediatricians, physicians, anaesthesists and emergency
physicians have also expanded to include PSA. For non-operating room
anesthesia, (NORA) dexmedetomidine offers a safety profile similar to
traditional sedatives (i.e., ketamine and midazolam) and has been reported to
be efficacious even when administered intranasally (IN).
We plan to conduct this research as Intranasal
administration of dexmedetomidine may be advantageous for such procedures in
pediatric population, as compared to intravenous route as it is shown to
have lesser hemodynamic changes and preserves the airway better, additionally,
the fear and anxiety triggered by needles and closed environment are also less. |