| 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
|
|
|
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
|
|
|
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. |