| CTRI Number |
CTRI/2024/10/074912 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The study examines the effect of two doses of intravenous dexmedetomidine on emergence agitation in pediatric patients undergoing inguinal hernia surgeries with general anesthesia using sevoflurane. It aims to determine whether dexmedetomidine can reduce agitation during recovery.
|
|
Scientific Title of Study
|
Comparison of two doses of intravenous Dexmedetomidine on emergence agitation in paediatric patients undergoing inguinal hernia surgeries under general anaesthesia with sevoflurane
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ankit |
| Designation |
PG resident |
| Affiliation |
VMMC and SJH |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi - 110029
South
DELHI 110029
South
DELHI
110029
India |
| Phone |
9582524264 |
| Fax |
|
| Email |
ankitvermaatvmmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MEENAKSHI KUMAR |
| Designation |
Consultant and Professor |
| Affiliation |
VMMC and SJH |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi - 110029
South
DELHI 110029
South
DELHI
110029
India |
| Phone |
9899689829 |
| Fax |
|
| Email |
drmeenakshi86@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MEENAKSHI KUMAR |
| Designation |
Consultant and Professor |
| Affiliation |
VMMC and SJH |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi - 110029
South
DELHI 110029
DELHI
110029
India |
| Phone |
9899689829 |
| Fax |
|
| Email |
drmeenakshi86@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Ground Floor, Main OT Complex, VMMC & Safdarjung Hospital, Ansari Nagar(in front of AIIMS), New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Vmmc and SJH |
| Address |
Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi - 110029
South
DELHI 110029 |
| 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 |
| Dr Ankit |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi - 110029 South
DELHI
South
DELHI |
9582524264
ankitvermaatvmmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
0.25µg/kg of Dexmedetomidine
diluted in 5ml NaCl 0.9% over a
period of 5 min |
| Comparator Agent |
Dexmedetomidine |
0.5µg/kg of Dexmedetomidine diluted in
5ml NaCl 0.9% over a period of 5 min |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 1-6 years fulfilling the criteria of American Society of Anesthesiologists physical
status I and II undergoing inguinal hernia surgeries under general
anaesthesia with sevoflurane will be included in the study. |
|
| ExclusionCriteria |
| Details |
The patients with following history will be excluded from the study:
1. Allergy to any of the drugs use
2. Known Congenital heart disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of two doses of Dexmedetomidine on the incidence of emergence
agitation in pediatric patients undergoing inguinal hernia surgeries under general anaesthesia
with sevoflurane by using the PAED scale. |
0min ,10min ,20min ,30min ,40min after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the recovery profile in terms of emergence time, extubation time, and
discharge time from the recovery room using the Steward recovery score.
2. FLACC Score – To assess postoperative analgesia.
3. To study Intraop and Postop hemodynamic parameters
4. Postop Fentanyl requirement. |
40 minutes after extubation |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/10/2024 |
| 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="5"
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
|
Emergence agitation is commonly seen in children during recovery from general anaesthesia.1 It is associated with symptoms such as combative movements, excitability, thrashing, disorientation, inconsolable crying, and restlessness. 2 This behaviour results in anxiety, delayed discharge from the post anesthestic care unit, and creates problems for parents as well as caregivers. 3 It occurs for a short duration, but it may require pharmacological intervention, resulting in a prolonged post-anesthesia care unit stay. As, the pathophysiology is unknown but risk factors include preschool age, preoperative anxiety, postoperative pain, nausea, vomiting, and inhalational anaesthetics specially sevoflurane.4 Dexmedetomidine is a highly potent and selective alpha-2 adrenoreceptor which has sedative, anxiolytic, and analgesic properties without significant respiratory depression. 9 It has been used effectively in intensive care to aid weaning from mechanical ventilation and now is being utilized increasingly in paediatric anaesthesia.5 It has been used by various authors intranasally and intravenously as a bolus and continuous intravenous (IV) infusion to suppress the incidence of EA in various surgeries such as adenotonsillectomy, cleft lip & palate repair, and strabismus correction.3,5,10 Limited literature is available regarding the lowest dose of Dexmedetomidine for the prevention of emergency agitation in paediatric patients. Therefore, in this study, we are planning to evaluate the effect of low dose of intravenous Dexmedetomidine on emergence agitation in paediatric patients undergoing inguinal hernia surgeries under general anesthesia with sevoflurane |