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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Approved/Obtained 
 
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.  

 

 

 

 
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