| CTRI Number |
CTRI/2019/06/019711 [Registered on: 17/06/2019] Trial Registered Prospectively |
| Last Modified On: |
16/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparison of Midazolam and Dexmedetomidine as Medication to be given in Nose before Anesthesia in Lower Body Surgeries of Children |
|
Scientific Title of Study
|
A Comparative Analysis of Intranasal Midazolam and Intranasal Dexmedetomidine as Premedication in Pediatric Infraumbilical Surgeries: A Prospective Randomized Double-blind Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aikta Gupta |
| Designation |
Specialist Grade-I |
| Affiliation |
Chacha Nehru Bal Chikitsalaya, New Delhi |
| Address |
Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
Delhi
East
DELHI
110031
India |
| Phone |
9643308230 |
| Fax |
|
| Email |
aiktab@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Payaswinee Sharma |
| Designation |
Fellow in Pediatric Anesthesia |
| Affiliation |
Chacha Nehru Bal Chikitsalaya, New Delhi |
| Address |
Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
Delhi
East
DELHI
110031
India |
| Phone |
9200022287 |
| Fax |
|
| Email |
payaswinee87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payaswinee Sharma |
| Designation |
Fellow in Pediatric Anesthesia |
| Affiliation |
Chacha Nehru Bal Chikitsalaya, New Delhi |
| Address |
Department of Anesthesia
Chacha Nehru Bal Chikitsalaya
Geeta Colony
Delhi
East
DELHI
110031
India |
| Phone |
9200022287 |
| Fax |
|
| Email |
payaswinee87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chacha Nehru Bal Chikitsalaya, Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Aikta Gupta |
| Address |
Specialist Grade I,
Department of Anesthesia,
Chacha Nehru Bal Chikitsalaya,
Geeta Colony,
New Delhi,
Pin 110031 |
| Type of Sponsor |
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 Aikta Gupta |
Chahcha Nehru Bal Chikitsalaya |
Department of Anesthesia, 2nd Floor, Chacha Nehru Bal Chikitsalaya, Geeta Colony
Delhi - 110031
East
DELHI |
9643308230
aiktab@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Chacha Nehru Bal Chikitsalaya, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Intranasal instillation 30 minutes prior to induction of anesthesia in dose of 0.5 mcg per kg body weight over duration of 30 seconds once only |
| Comparator Agent |
Midazolam |
Intransal instillation 30 minutes prior to iduction of anesthesia in dose of 0.2 mg per kg body weight over duration of 30 seconds once only |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children undergoing infraumbilical surgeries
2. ASA grade I and II |
|
| ExclusionCriteria |
| Details |
1. Patients having known allergy to the drugs used in study
2. Patients having upper respiratory infection
3. Patients having neurological disorders
4. Patients under treatment with anticonvulsants/sedatives
5. Patients spitting out the medication
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Preoperative Sedation Score |
Prior to administration of study drugs and thereafter every 10 minutes till patients in shifted into operating room |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parental separation score |
At the time of shifting into operating room |
Mask acceptance score
|
At the time of induction of anesthesia |
Preoperative and intraoperative vital parameters
|
Prior to administration of study drugs and thereafter every 10 minutes until completion of surgery and shifting of patient into post anesthesia care unit |
| Postoperative emergence (Cravero score) |
After completion of surgery and shifting into post anesthesia care unit |
| Immediate postoperative sedation score |
After completion of surgery and shifting into post anesthesia care unit |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/06/2019 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a hospital-based, prospective, comparative, randomized, double-blind study to be conducted at Department of Anesthesia, Chacha Nehru Bal Chikitsalaya, New Delhi. The inclusion criteria are children aged 2-10 years undergoing elective infraumbilical surgeries of ASA grade I and II. 70 patients will be allocated in two groups, Group A (receiving intranasal midazolam 0.2 mg/kg) and Group B (intranasal dexmedetomidine 0.5 mcg/kg). The primary outcome measure is preoperative sedation score at the time of shifting into OT and the secondary outcome measure are parental separation score, mask acceptance score, preoperative and intraoperative vital parameters, postoperative emergence (Cravero score) and immediate postoperative sedation score. |