| CTRI Number |
CTRI/2025/02/081317 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on preoperative sedation in pediatric surgery. |
|
Scientific Title of Study
|
Comparison Of Oral Premedication In Children With Midazolam, Dexmedetomidine And Melatonin For Ease Of Separation From Parents Before Anesthesia : A Randomized Controlled Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Agathiyan A |
| Designation |
Postgraduate |
| Affiliation |
srm medical college |
| Address |
Room No 6, Second Floor, Department Of Anaesthesia, Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9894280868 |
| Fax |
|
| Email |
agathiyananbu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saravanan C R |
| Designation |
Professor |
| Affiliation |
srm medical college |
| Address |
Room No 6, Second Floor, Department Of Anaesthesia, Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884001153 |
| Fax |
|
| Email |
drcrsaravanan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saravanan C R |
| Designation |
Professor |
| Affiliation |
srm medical college |
| Address |
Room No 6, Second Floor, Department Of Anaesthesia, Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884001153 |
| Fax |
|
| Email |
drcrsaravanan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia, Srm Medical College. |
|
|
Primary Sponsor
|
| Name |
Agathiyan A |
| Address |
Room No 6, Second Floor, Department Of Anaesthesia, Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.603203 |
| 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 |
| Agathiyan A |
srm medical college |
Srm Medical College, Srm Nagar, Kattangulathur, Chengalpattu.
Kancheepuram
TAMIL NADU |
9894280868
agathiyananbu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srm Medical College Hospital And Research Centre Institutional Ethics Committee |
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 |
Oral Dexmedetomidine |
2.5mcg/Kg In Children Undergoing Surgery Per Orally Single Dose Stat 60 Mins Before Surgery. |
| Intervention |
Oral Melatonin |
0.5mg/Kg In Children Undergoing Surgery Per Orally Single Dose Stat 60 Mins Before Surgery. |
| Comparator Agent |
Oral Midazolam |
0.5mg/Kg In Children Undergoing Surgery Per Orally Single Dose Stat 60 Mins Before Surgery. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 2 to 6 years.
Undergoing Elective surgery.
Children Assessed under ASA I ,II.
|
|
| ExclusionCriteria |
| Details |
Children with difficult airway.
Children with intellectual Disability .
ADHD and other psychiatric / Sleep disorders.
Children with pre existing liver ,Renal ,Heart problems.
Children whose parents/Guardians are not willing for the consent and the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ease Of Separation From Parents By A Scale
|
60 Mins After Drug Adminstration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preoperative Anxiety By Modified Yale Scale |
60 Mins After Drug Adminstration |
| Sedation By Observer Sedation Score |
60 Mins After Drug Adminstration |
| Mask Acceptance By Mask Acceptance Score |
60 Mins After Drug Adminstration |
| Hemodynamics |
Perioperatively Every 15 Mins Once And Continued Till 1hour Post Opertaive |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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)
|
28/03/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
All
children undergoing elective surgeries requiring premedication will be
explained in detail.
Eligible
children will be recruited consecutively and will be randomized using computer
generated random envelope method. The random allocation sequence will be
generated by the support staff of the institute who will not be part of the
study.
Children
will be randomly divided into 3 groups,
Group M – Children receiving oral
midazolam
Group MT– Children receiving oral
melatonin
Group D- Children receiving oral
dexmedetomidine
All
children will be assessed preoperatively, will have to undergo basic
investigations (CBC, Coagulation profile, ECG,CXR)and written consent will be
obtained .
Basal
heart rate, systolic blood pressure ,diastolic blood pressure , mean arterial
pressure, oxygen saturation, respiratory rate will be recorded in premedication
room before giving premedication.
Group M children will receive oral
Midazolam 0.5mg/kg .
Group MT children will receive oral
Melatonin 0.5mg/kg .
Group D children will receive oral
Dexmedetomidine 2.5mcg/kg .
Basal
heart rate, systolic blood pressure ,diastolic blood pressure , mean arterial
pressure, oxygen saturation, respiratory rate and ETCO2 will be recorded every
15 mins from the administration of premedication .
The
score for ease of separation from parent will be recorded after 60 mins from
the administration of premedication.
The
score for Preoperative Anxiety will be assessed after 60 mins from the
administration of premedication using
modified yale preoperative anxiety scale.
Sedation
will be reassessed 60 mins after the premedication using observer sedation
score.
Mask
acceptance scores will also be recorded after 60 mins from the administration
of premedications .
Basal
heart rate, systolic blood pressure ,diastolic blood pressure , mean arterial
pressure,oxygen saturation ,respiratory rate ,etco2 will be recorded
postoperatively for 1 hour in the recovery room.
|