| CTRI Number |
CTRI/2025/11/096896 [Registered on: 04/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the use of two medicines Dexmedetomidine and Midazolam used intranasally and its effect on calming down children before planned surgeries.
|
|
Scientific Title of Study
|
Comparison of Intranasal Dexmedetomidine with Intranasal Midazolam as Premedication in Children Undergoing Elective Surgeries- A Randomised Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjana B S |
| Designation |
Post graduate |
| Affiliation |
Malankara Orthodox Syrian Church Medical College |
| Address |
TC 17/2088, Sathyanarayana gardens, Dr Pai road, Poojapura P O, Trivandrum Post graduate resident, Department of Anaesthesiology and Critical care, Kolenchery Ernakulam KERALA 695012 India |
| Phone |
9495363337 |
| Fax |
|
| Email |
dranjanabs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rakhee S |
| Designation |
Professor |
| Affiliation |
Malankara Orthodox Syrian Church Medical College |
| Address |
Department of Anaesthesiology and Critical care Kolenchery Ernakulam KERALA 682311 India |
| Phone |
94955 67033 |
| Fax |
|
| Email |
rakheeksd79@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anjana B S |
| Designation |
Post graduate |
| Affiliation |
Malankara Orthodox Syrian Church Medical College |
| Address |
TC 17/2088, Sathyanarayana gardens,Dr Pai road, Poojapura P O, Trivandrum Kolenchery Ernakulam KERALA 695012 India |
| Phone |
9495363337 |
| Fax |
|
| Email |
dranjanabs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Malankara Orthodox Syrian Church Medical College, Kolenchery, Ernakulam |
|
|
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 = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjana B S |
Malankara Orhthodox Medical College |
Department of Anaesthesiology and Critical care
Ground floor Ernakulam KERALA |
9495363337
dranjanabs@gmail.com |
| Dr Anjana B S |
Malankara Orthodox Syrian Church Medical College Operation Theatre |
Operation Theatre Complex
Department of Anaesthesiology and Critical care
Ground floor Ernakulam KERALA |
9495363337
dranjanabs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MALANKARA ORTHODOX SYRIAN CHURCH MEDICAL COLLEGE |
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 |
Intranasal Dexmedetomidine |
Group D recieves Intranasal Dexmedetomidine 1mcg/kg 30 minutes prior to surgery |
| Intervention |
Intranasal Midazolam |
Group M recieves Intranasal Midazolam 0.2 mg/kg 30 minutes prior to study |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 1 to 8 years
2. ASA I and II
3. Elective surgeries
|
|
| ExclusionCriteria |
| Details |
1. Patients with respiratory tract infections or nasal obstruction.
2. Congenital anomalies to nasal or oral cavity
3. H/O allergy
4. Parental refusal to consent
|
|
|
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 |
| To compare the preoperative sedation and response of child to parental separation, in patients receiving intranasal dexmedetomidine and intranasal midazolam as premedication. |
0,5,10,15,20,25,30 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preoperative sedation score |
0,5,10,15,20,25,30 MINUTES |
| Mask acceptance |
After 30 MINUTES |
| Post operative agitation |
After surgery |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
25/11/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
After obtaining Institutional Ethics Committee clearance and explaining the study in detail, written informed consent will be procured from parents. The patients are randomized into two groups dexmedetomidine (group D) and midazolam (group M) by a computer generated randomization list prepared by an anaesthesiologist not involved in the study. The principal investigator is blinded to the computer generation of random numbers and sealed envelope method will be used during the conduct of study. The allotted patients will be kept nil per oral as per the standard fasting guideline protocol. The child is brought to the premedication room and are administered with either intranasal dexmedetomidine 1 mcg/kg or intranasal midazolam 0.2 mg/kg 30 minutes prior to the procedure on the day of surgery. The premedication drug is prepared by a person not involved in the study, either of the drug is taken in a 2 ml syringe and is diluted to 2 ml. It is instilled into both the nostrils by the principal investigator using an atomiser. In the premedication room, the patient’s heart rate and SPO2 are monitored at 5 minutes interval. After 30 minutes, parental separation anxiety is assessed using appropriate score. The child is shifted to the operating theatre and standard ASA monitors are attached. All children are given Inhalational induction using sevoflurane followed by assessment of mask acceptance using Mask acceptance score. Tracheal intubation will be done after administration of standard non-depolarizing muscle relaxant, anaesthesia will maintained by O2 , air and sevoflurane and analgesia will provided by fentanyl and paracetamol. Ventilation will be controlled by either Jackson-Ree’s modification of Ayre’s T-piece or pediatric closed circuit. Residual neuromuscular paralysis will be reversed at the end of operation by appropriate dose of neostigmine and glycopyrrolate. In all patients heart rate, systolic blood pressure, diastolic blood pressure and mean arterial blood pressure are measured at baseline and at 5 min interval throughout the procedure. Post extubation emergence agitation is assessed using the Cravero emergence agitation score. Hemodynamic parameters are measured postoperatively in the recovery room till the patient is shifted. |