FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/12/022270 [Registered on: 06/12/2019] Trial Registered Prospectively
Last Modified On: 19/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two drugs as premedication in children  
Scientific Title of Study   To compare the efficacy of nebulized dexmedetomidine and nebulized ketamine for premedication in paediatric patients undergoing hernia repair under general anaesthesia: A randomised comparative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrGeeta Singariya 
Designation  Senior Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Department of Anaesthesia, Dr. S.N. medical collage, Jodhpur
Dr. S.N. medical collage, Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrGeeta Singariya 
Designation  Senior Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Department of Anaesthesia, Dr. S.N. medical collage, Jodhpur
Dr. S.N. medical collage, Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Namita Malhotra 
Designation  Junior Resident 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Department of Anaesthesia, Dr. S.N. medical collage, Jodhpur 342001 India
Dr. S.N. medical collage Jodhpur
Jodhpur
RAJASTHAN
342003
India 
Phone  09781188820  
Fax    
Email  malhotra.namita2210@gmail.com  
 
Source of Monetary or Material Support  
DR S N Medical College Jodhpur Rajasthan 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Government 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 
DrGeeta Singariya  Umaid Hospital  Main OT Complex First floor Umaid Hospital, Dr S N medical collage Jodhpur
Jodhpur
RAJASTHAN 
09414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group D (Dexmedetomidine)  Patients receiving nebulized dexmedetomidine in a dosage of 2µg/kg body weight 
Comparator Agent  Group K (ketamine)  Patients receiving nebulized ketamine in a dosage of 2 mg/kg body weight  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Patients aged 2 to 8 years of either gender of ASA PS I and II undergoing hernia repair surgery under general anaesthesia 
 
ExclusionCriteria 
Details  any congenital heart disease,
upper respiratory tract infection,
known allergy to study drug,
any nasal disorder like recurrent nasal bleed or nasal masses,
known allergy to propofol or egg products,
surgical duration more than 60 minutes
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the level of sedation by Ramsay sedation scale in both groups.  30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1. Parental separation anxiety score
2. Acceptance of mask induction
3. Recovery time
4. Emergence agitation
5. Haemodynamic changes
6. Side effects if any.

 
Postoperative till patient awake 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/12/2019 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

The preoperative period is a stressful event for the majority of individuals undergoing surgery. This is especially true in the paediatric patient due to a limited understanding of the nature of the illness and the need of surgery in young children. Paediatric anesthesiologists strive to minimize distress for children in the operating room (OR) environment and to provide a smooth induction of anaesthesia. Preoperative anxiety stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in heart rate (HR) and blood pressure (BP). There is a association between preoperative anxiety and an increased incidence of adverse postoperative clinical outcomes in paediatric patients. Postoperative behavioural changes related to stressful hospital experiences/induction of anaesthesia include general anxiety, enuresis, night-time crying, and temper tantrums. These changes are usually transient but may persist for up to one year. The incidence is greatest in pre-school children in whom it can be reduced by psychological preparation, premedication, and the support of parents.

Various pre-induction techniques in paediatric anaesthesia are primarily focused on relieving the preoperative anxiety of the child, but consideration of parental anxiety is also important. The use of pre-induction techniques is, in many respects, unique to paediatric anaesthesia, and therefore can be challenging for the anaesthetist who practices paediatric anaesthesia on an occasional basis. To alleviate preoperative anxiety and enable smooth parental separation, various drugs have been advocated suitable for use as sedative premedication. Midazolam, a GABA agonist, is the drug most frequently used for paediatric premedication. Fentanyl, an opioid analgesic whose effects are mediated via the m-opioid receptors. It is rapidly absorbed via the transmucosal route and for premedication, it is presented as a pleasant tasting lollipop. Ketamine is an N-methyl-d-aspartate (NMDA) receptor antagonist that produces a state of sedation, anaesthesia, immobility, analgesia, and amnesia. Dexmedetomidine, (DEX)  a-2 agonists have emerged as new alternative of premedication in paediatric anaesthesia. DEX has a differential specificity for the a1:a2 receptors of 1:1620, compared with 1 : 220 for clonidine, being considered a full and highly selective agonist of a-2-adrenergic receptors. Clinical investigations have demonstrated its sedative, analgesic and anxiolytic effects after intravenous administration to volunteers and post-surgical patients.

The present study will be designed to compare the efficacy of nebulized dexmedetomidine and nebulized ketamine for premedication in pediatric patients undergoing elective surgery under general anaesthesia.


 
Close