FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/066183 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 13/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparison of effectiveness of Oral Dexmedetomidine,ketamine alone versus combination of both in sedation and anxiety, in children posted for surgery 
Scientific Title of Study   A Comparative study of oral Dexmedetomidine,Ketamine alone Versus a combination of both as premedication in paediatric patients posted for surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shahin c 
Designation  PG Student  
Affiliation  Pandit Deendayal Upadhyay Medical College, Rajkot  
Address  Anaesthesiology Department Third floor,OPD building PDU medical college and hospital,Sadar,Rajkot,Gujarat,India 360001

Rajkot
GUJARAT
360001
India 
Phone  6238586245  
Fax    
Email  shahinchembilaly@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jigisha Badheka 
Designation  Associate Proffessor 
Affiliation  Pandit Deendayal Upadhyay Medical College, Rajkot  
Address  Department of Anaesthesia Third Floor,Opd building Pandit Deendayal Upadhyay Medical College,Sadar, Rajkot

Rajkot
GUJARAT
360001
India 
Phone  9879570170  
Fax    
Email  jagu_jigi@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jigisha Badheka 
Designation  Associate Proffessor 
Affiliation  Pandit Deendayal Upadhyay Medical College, Rajkot  
Address  Department of Anaesthesia Third Floor,Opd building Pandit Deendayal Upadhyay Medical College,Sadar, Rajkot


GUJARAT
360001
India 
Phone  9879570170  
Fax    
Email  jagu_jigi@yahoo.com  
 
Source of Monetary or Material Support  
PDU Medical College and Hospital,sadar ,Rajkot,Gujarat,India 360001 
 
Primary Sponsor  
Name  Shahin c 
Address  Pandit dindayal upadhyay medical college and hospital sadar, Rajkot - 360001, Gujarat, India 
Type of Sponsor  Other [Self] 
 
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 
Dr Shahin c  Pandit Deendayal Upadhyay Medical College, Rajkot   Anaesthesia Department,Third floor, opd building,sadar,Rajkot 360001,Gujarat,India
Rajkot
GUJARAT 
6238586245

shahinchembilaly@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human) P.D.U. Medical College, Rajkot.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (2) ICD-10 Condition: N40-N53||Diseases of male genital organs, (3) ICD-10 Condition: Q35-Q37||Cleft lip and cleft palate, (4) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (5) ICD-10 Condition: V00-Y99||External causes of morbidity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Oral Premedication with Ketamine ,Dexmedetomidine and combination of both drugs   The patients will be grouped into 3 groups according to the drugs they are given 1. Group D - Dexmedetomidine(4mcg/kg) 2. Group K - Ketamine(4-8mg/kg) 3. Group KD - Combination of both(dexmedetomidine 2mcg/kg and ketamine 4 mg/kg) Patient is kept nil by mouth for a minimum of 6 hours prior to surgery IV solutions of drugs(as oral solution of drugs is not available) calculated according to the weight of the patients will be taken and mixed with Honey of same amount to make it palatable will be given 40 minutes prior to surgery Pre-operative vitals of each patients will be taken before giving the pre-medication and then every 10 minutes The patients will be given either of the pre-medications or combination of both in the calculated amount with equal amount of honey The vitals of the patients will be taken after giving the pre-medication, and then every 10 minuters 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  patients with ASA 1 or 2
patients posted for elective surgery 
 
ExclusionCriteria 
Details  Patients below age 2 and above age 12
patient belonging to ASA grade more than 2
Patient undergoing any emergency surgry
syndromic children
Child with Respiratory Tract Infections 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare the effects of Dexmedetomidine, Ketamine and combination of both in sedation, analgesia and reducing anxiety  The level of sedation of the patient will be examined before and after 5,10,20,30,40,60 minutes of giving premedicvation on a five point scale (SS-5)
1.Rarely awake,responds to shouting or shaking
2.Asleep eyes closed
3.Sleepy but eyes open spontaneously
4.Awake
5.Agitated 
 
Secondary Outcome  
Outcome  TimePoints 
study will compare oral Dexmedetomedine, oral ketamine and combination of both in their effects on the ease of separation from parents, the acceptance for IV cannulation and face mask application  After assessing the level of sedation, i.e., 40 minutes from giving the pre-medication, the difficulty in separating the patients from their parents will be evaluated on a 4 point scale

After moving the patient to the operating room, the IV acceptability score will be assesed on
a 4 point scale

After inserting the IV cannulation, the mask acceptance by the patients will be evaluated on a 5 point scale 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3/ Phase 4 
Date of First Enrollment (India)   30/04/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shahinchembilaly@gmail.com].

  6. For how long will this data be available start date provided 30-10-2025 and end date provided 30-10-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
INTRODUCTION:  Anaesthesia and Surgery can be stressful and traumatic experiences for children. They are especially vulnerable to long term Psychological Impairment resulting from stress. Incidence of pre-op anxiety is about 60-70 %in paediatric patients. This is associated with increased risks of negative effects as difficult induction, post-operative agitation and increased post-op pain.
Premedication are frequently administered in children to alleviate the stress and fear of treatmen well as to ease child-parent separation and promote a smooth induction of anaesthesia. Different kinds of medications have been used for pre-medication such as anticholinergic drugs, opioids, benzodiazepines and ketamine.

On literature search there are various studies on Oral midazolam, In those studies It alleviates an
and provide adequate sedation but has increased Risk of Respiratory Depression. Various studies
have been done for Oral premedication as alone or in combination, comparing Ketamine and
Midazolam, but very few studies compared the Oral Dexmedetomidine and Oral Ketamine.
Clonidine has significant analgesic properties because of its alpha-2-adrenergic agonism. One major downside of clonidine is longer duration of onset requiring administration 60 minutes before anaesthesia induction.

Ketamine is an easily administered parental anaesthetic that produces profound analgesia in sub- anaesthetic doses and lacks the cardiorespiratory depression seen with most other general anaesthetics. Ketamine is a phencyclidine derivative which acts on the n-methyl d-aspartate rece and causes central dissociation of the cerebral cortex while providing amnesia and analgesia and applied for premedication in different studies. Ketamine is most commonly used as premedicatio have been used to provide sedation and analgesia but may cause Nausea and Vomiting.
New Drugs such as Dexmedetomidine which is an Alpha-2-Agonist have emerged as an alternative for Premedication in Paediatric Anaesthesia having sedative, analgesic and anxiolytic property minimal respiratory depression and better Peri Operative Haemodynamic stability.
Dexmedetomidine and ketamine exhibit complementary pharmacological effects. Dexmedetomidine reduces cardiovascular responses and postoperative psychiatric adverse reactions attributed to




AIMS OF THE STUDY:
Primary: Compare the effects of Dexmedetomidine, Ketamine and combination of both in sedation, analgesia and reducing anxiety
Secondary: Our study will compare oral Dexmedetomedine, oral ketamine and combination of both in their effects on the ease of separation from parents, the acceptance for IV
cannulation and face mask application Expected outcome: To know the better pre-medication drug among children between oral
ketamine, oral dexmedetomidine and combination of both

METHODOLOGY OF THE STUDY:
This will be a Randomised, Comparative. Double Blinded Prospective Study of 90 Patients between 2- 12 Years of Age.
All Patients of ASA I and II Posted for Surgery between 2-12 years of age will be enrolled in the Study.

RISKS
No major risk involved

BENEFITS OF THE STUDY
Smooth induction
Less peri-operative anxiety
Less requirement of additional sedative doses of Ketamine
Easy parental separation
IV acceptability is good
Easy mask acceptance
Convenient and appealing method of sedation
 
Close