| CTRI Number |
CTRI/2021/04/032511 [Registered on: 01/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of blood levels and Sedation of Dexmedetomidine through mouth and nose in Children |
|
Scientific Title of Study
|
Comparison of Pharmacokinetics and Sedative Effect of Sublingual and Intranasal Dexmedetomidine in Children: A Double-Blind Randomised Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renu Sinha |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, Room No.-376, Dr Rajendra Prasad centre for Ophthalmic Sciences, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
9810305156 |
| Fax |
|
| Email |
renusinhaagarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renu Sinha |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, Room No.-376, Dr Rajendra Prasad centre for Ophthalmic Sciences, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
9810305156 |
| Fax |
|
| Email |
renusinhaagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Armanullah Khan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Pain Medicine and Critical Care,AIIMS,Ansari Nagar
South
DELHI
110029
India |
| Phone |
7632846666 |
| Fax |
|
| Email |
armanullahkh@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences,Ansari Nagar,New Delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Renu Sinha |
AIIMS, New Delhi |
Department of Anaesthesiology, Pain Medicine and Critical Care
New Delhi
DELHI |
9810305156
renusinhaagarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committe,AIIMS,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intransal Dexmedetomidine |
30 minutes Before anaesthesia intranasal dexmedetomidine will be given |
| Intervention |
Sublingual Dexmedetomidine |
30 minutes Before anaesthesia sublingual dexmedetomidine will be given |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA Grade 1 and 2 Patients.
2)Weight 10 to 30 kg. |
|
| ExclusionCriteria |
| Details |
1)Parental refusal
2)ASA III, IV
3)OSA
4)Difficult airway
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the pharmacokinetics of 2 mcg/kg sublingual and intranasal dexmedetomidine in children |
Forty-five minutes before the induction of anaesthesia up to 120 minutes after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To evaluate the onset and duration of sedation with sublingual and intranasal Dexmedetomidine.
2)To evaluate the quality of parental separation and the mask acceptance with sublingual and intranasal Dexmedetomidine
3)To evaluate perioperative operative vitals (HR, SpO2, MAP) with sublingual and intranasal Dexmedetomidine
4)To evaluate perioperative analgesia with sublingual ad intranasal Dexmedetomidine and post-operative recovery score with sublingual and intranasal Dexmedetomidine |
Forty-five minutes before the induction of anaesthesia upto 120 minutes after surgery. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2021 |
| Date of Study Completion (India) |
19/08/2022 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Children prefer pain free, irritation-free methods for administration of premedication. Different drugs with different formulations have been used as premedication like midazolam, clonidine, dexmedetomidine, chloral hydrate, etc. Dexmedetomidine is a highly selective alpha-2-adrenergic agonist with potent anxiolytic sedative and analgesic effects. Dexmedetomidine has been used via buccal, nebulization, sublingual, intranasal, oral, etc, routes for premedication. We are planning to evaluate and compare the pharmacokinetics and sedative effect of sublingual dexmedetomidine with intranasal dexmedetomidine in children. After doing pre-anaesthetic check-up and obtaining consent, patient will be taken up for study. Intravenous cannulation will be done first to take blood samples at various intervals. Then According to the randomization, 30 minutes before the induction of anaesthesia, anaesthesiologist not involved in the study will administer dexmedetomidine at the dose of 2mcg/kg via the sublingual route in the group sublingual or intranasal route in group intranasal and saline will be administered via intranasal route in the group sublingual or via sublingual route in the group intranasal to maintain blinding. Time and duration of sedation, separation from parents, face mask acceptance for anaesthesia, recovery after anaesthesia and pain relief will be observed at various time intervals.
|