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CTRI Number  CTRI/2024/05/066745 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study and compare efficacy of 3 drug groups given as a nasal spray used to reduce anxiety and parenteral separation in children before surgery 
Scientific Title of Study   To study and compare efficacy of anaesthetic premedication in the form of intranasal dexmedetomidine and ketamine v/s intranasal midazolam v/s intranasal ketamine and midazolam in the paediatric age group 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tanmaya Sachdeva 
Designation  Junior Resident 
Affiliation  Swami Rama Himalayan University 
Address  Department of Anaesthesiology,Himalayan institute of Medical Sciences,Swami Rama Himalayan University,Jolly grant,Dehradun,Pin code-248140

Dehradun
UTTARANCHAL
248140
India 
Phone  8884841411  
Fax    
Email  tanmayasach@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Priya Ramakrishnan 
Designation  Associate Professor 
Affiliation  Swami Rama Himalayan University 
Address  Department of anaesthesiology,Himalayan Institute of Medical Sciences,Swami Rama Himalayan University,Jolly Grant,Dehradun,Pin code-248140

Dehradun
UTTARANCHAL
248140
India 
Phone  9149225153  
Fax    
Email  priyarkrishnan@srhu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Tanmaya Sachdeva 
Designation  Junior Resident 
Affiliation  Swami Rama Himalayan University 
Address  Department of Anaesthesiology,Himalayan Institute of Medical Sciences,Swami Rama Himalayan University,Jolly Grant,Dehradun,Pin code-248140

Dehradun
UTTARANCHAL
248140
India 
Phone  8884841411  
Fax    
Email  tanmayasach@gmail.com  
 
Source of Monetary or Material Support  
Himalayan Institute of Medical Sciences,Swami Rama Himalayan University,Jolly Grant,Dehradun,Pin code-248140 
 
Primary Sponsor  
Name  Swami Rama Himalayan University 
Address  Himalayan Institute of Medical Sciences,Swami Rama Himalayan University,Jolly Grant,Dehradun,248140 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
tanmaya sachdeva  Himalayan Institute of Medical Sciences  1st floor, Department of Anaesthesiology, Main building,Himalayan Institute of Medical Sciences,Swami Rama Himalayan University
Dehradun
UTTARANCHAL 
8884841411

tanmayasach@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
himlayan institute of medical sciences,swami rama himalayan university,jolly grant,dehradun,248140  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intranasal Dexmedetomidine and Ketamine   Group DK- Route- intranasal through universal atomiser Dose- 2.0 microgram/kg of dexmedetomidine and 1mg/kg of ketamine Frequency- using the atomiser, the prepared drug is administered cautiously in both nostrils Duration-given 30 mins prior to induction  
Comparator Agent  Intranasal Ketamine and Midazolam  Group KM- Route-Intranasal Dose-1mg/kg ketamine and 0.15mg/kg of midazolam Frequency- using the atomiser, the prepared drug is administered cautiously in both nostrils Duration-given 30 mins prior to induction  
Intervention  Intranasal Midazolam  Group M Route-Intranasal Midazolam Dose-0.2mg/kg Frequency- using the atomiser, the prepared drug is administered cautiously in both nostrils Duration-given 30 mins prior to induction  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children in the age group of 2-10 years
ASA grade 1 or 2
Either sex
Undergoing elective surgery procedures requiring GA with either Endotracheal Tube/Laryngeal mask airway for those patients in which consent has been given
 
 
ExclusionCriteria 
Details  children less than 2 and more than 10 years
ASA grade more than 2
emergency surgeries
known allergies to the above mentioned drugs
developmental delays/mental retardation
history of sedative/analgesic intake
history of congential heat disease/arrythmias
case of URTI
significant nasal discharge/obstruction
severe trauma of nose
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
parental separation anxiety based on a 4 point scoring system
 
time interval taken to achieve a parental separation score of more than or equal to 2 as a desirable parameter 
 
Secondary Outcome  
Outcome  TimePoints 
mask acceptance
intraop opiod use
post op agitation
post op emergence delirium
post op nausea and vomiting 
intraop till end of surgery
post op till 30 mins for agitation and 24 hours for rest 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   14/05/2024 
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="9"
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  

 

 

AIMS AND OBJECTIVES

1.    To study and compare efficacy of anaesthetic premedication in the form of intranasal dexmedetomidine and ketamine v/s intranasal midazolam v/s intranasal ketamine v/s intranasal midazolam in the paediatric age group

2.To compare the different groups on the basis of proportion of children achieving acceptable parental separation as the primary outcome and sedation onset time, degree of sedation, mask acceptance, emergence delirium, post operative agitation, post operative nausea and vomiting, Perioperative opoid use and hemodynamics as the secondary outcome

BRIEF SUMMARY :

Hospitalisation and surgery can provoke significant stress and anxiety in children. The induction of anaesthesia may be the most distressing procedure a child experiences during the entire perioperative period .It has been shown that children who are extremely anxious and fearful during anaesthetic induction are likely to develop adverse clinical outcomes such as emergence delirium, increased analgesic requirements and negative postoperative behavioural changes such as sleep disturbance, separation anxiety, eating problems, new-onset enuresis and aggression towards authority which can sometimes persist upto 4-6 months after the procedure and is also associated with poor clinical recovery. A stressful perioperative experience can also result in poor compliance with future medical therapy, including anaesthesia. Minimising distress is thus not only an ethical imperative but also important for preventing long-term behavioural problems .Premedication refers to the administration of medication before induction of anaesthesia. In the pharmacological component, the available routes of premedication are rectal, intramuscular, oral, intranasal, topical (eg-before cannulation), intravenous . The benefits of intranasal route include non invasiveness, easy administration, more compliance, requires minimal training, shorter time of onset (rapid absorption), higher bioavailability (no first pass metabolism) so drug delivery is directly to the target organ, decreased systemic adverse effects, better absorption due to highly vascularised subepithelial tissue, no gastric adverse effects, safe and convenient.Owing to the challenges with individual drugs, the need arises to consider ideal drug combinations that can provide us the desired effect with minimal adverse events . A combination of ketamine and midazolam produces 90% successful anxiolysis as compared to <75% when either drug is given alone. The combination also works in achieving a greater degree of sedation and better analgesia and amnesia 

 We are taking a combination of dexmedetomidine with ketamine as it has a faster onset of action, prolonged sedation and also the combination of dexmedetomidine with ketamine reduces its cardiovascular effects and slowers the elimination, as dexmedetomidine is a strong inhibitor of the N-demethylation of ketamine to norketamine. Dexmedetomidine does not appear to be the ideal agent for painful procedures but when used together with ketamine, dexmedetomidine may limit the tachycardia, hypertension, salivation, and emergence phenomena from ketamine, whereas ketamine may prevent the bradycardia and hypotension from dexmedetomidine. A combination of ketamine and dexmedetomidine has low incidence of adverse effects, good analgesic, predictable recovery and no cardiorespiratory depression.  

 


 

 

 

 

 
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