| CTRI Number |
CTRI/2021/07/034831 [Registered on: 14/07/2021] Trial Registered Retrospectively |
| Last Modified On: |
10/07/2021 |
| 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
|
A COMPARATIVE STUDY OF INTRANASAL DEXMEDETOMIDINE AND INTRANASAL MIDAZOLAM FOR PREMEDICATION IN CHILDREN POSTED FOR TONSILLECTOMY |
|
Scientific Title of Study
|
A Comparative Study Of Intranasal Dexmedetomidine And Intranasal Midazolam For Premedication In Children Posted For Tonsillectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Girimurugan N |
| Designation |
Post Graduate student |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam, Madagadipet,
Puducherry.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9840469518 |
| Fax |
|
| Email |
drgirimurugan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balasubramanian |
| Designation |
Associate Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam, Madagadipet,
Puducherry.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9940764982 |
| Fax |
|
| Email |
drbalasubbu77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girimurugan N |
| Designation |
Post Graduate student |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam, Madagadipet,
Puducherry.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9840469518 |
| Fax |
|
| Email |
drgirimurugan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College and Hospital.
Madagadipet, Kalitheerthalkuppam, 605107 |
|
|
Primary Sponsor
|
| Name |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam, Madagadipet,
Puducherry 605 107 |
| Type of Sponsor |
Private medical college |
|
|
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 Girimurugan N |
Sri Manakula Vinayagar Medical College and Hospital |
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam, Madagadipet,
Puducherry – 605 107
Pondicherry
PONDICHERRY |
9840469518
drgirimurugan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children of age 6 to 12 yrs of ASA physical status 1 undergoing elective tonsillectoy., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Premedication with intranasal Dexmedetomidine (selective alpha-2 agonist) |
Intranasal Dexmedetomidine at dose of 1mcg/kg administered in preoperative holding area one hour before induction of anaesthesia. |
| Comparator Agent |
Premedication with intranasal midazolam |
Intranasal Midazolam at dose of 0.2mg/kg administered in preoperative holding area one hour before induction of anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing Elective Tonsillectomy
ASA physical status I |
|
| ExclusionCriteria |
| Details |
1.Recent upper respiratory tract infection/lower respiratory tract infection
2.Known allergy or Hypersensitivity reaction to dexmedetomidine or midazolam.
3.Renal and Hepatic failure
4.Leukaemia
5.Cardiac arrthymias
6.Congenital diseases
7.DEvelopmental delay. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of intranasal Dexmedetomidine 1mcg/kg and Intranasal Midazolam 0.2mg/kg administered one hour before induction to asses hemodynamics,sedation,co-operation for mask induction,anxiety level |
Hemodynamic-0 min to 120 min and sedation,co-operation for mask induction,anxiety level asses 0 min to 70 min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Childs acceptance of intranasal drugs
Incidence of side effect |
when premedication is administered
throughout the procedure and upto 1 hours after the end of procedure |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/11/2012 |
| Date of Study Completion (India) |
12/03/2014 |
| Date of First Enrollment (Global) |
21/11/2012 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomized double blind contro; clinical study was done in 100 children with age group 6 to 12 belonging to asa physical status 1,scheduled for tonsillectomy under general anaesthesia. The present study was to compare satisfactory sedation,co-operation for mask induction and alleviation of anxiety. The study group,group D (Dexmedetomidine, n=50) received 1mcg/kg of intranasal dexmedetomidine and group M (Midazolam, n=50) received 0.2mg/kg of intranasal midazolam. The two group were similar with regards to age,gender,duration of surgery and duration of anaesthesia,extubation time. Premedication in paediatric patients using intranasal dexmedetomidine is more effective than intranasal midazolam in providing sedation and satisfactory conditions during parental separation. In term of providing ambient conditions during mask induction, both the drugs midazolam and dexmedetomidine are equally effective. There is no clinically significant difference in the hemodynamic parameters between the two groups. |