| 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 |
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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
|
|
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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 |
| 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 |
|
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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: O||Medical and Surgical, |
|
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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
|
|
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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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
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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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