| 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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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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 |
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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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 |
|
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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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shahinchembilaly@gmail.com].
- 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.
- 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 |