| CTRI Number |
CTRI/2024/11/076789 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two drugs, Ketamine and Dexmedetomidine in pediatric patients undergoing tonsillectomy. |
|
Scientific Title of Study
|
Comparison of ketamine vs dexmedetomidine given prior to extubation for prevention of emergence agitation in pediatric patients undergoing tonsillectomy- A double blinded randomized control trial.
|
| 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 Sauraya Pratap Singh |
| Designation |
JUNIOR RESIDENT Dept of Anesthesiology |
| Affiliation |
Heritage Institute of Medical Sciences ,Varanasi |
| Address |
Heritage Institute of Medical Sciences ,Dept of Anesthesiology,4th floor, Room No- 6 ,NH-2 By pass Bhadwar Varanasi Uttar Pradesh 221311 India
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
8604443305 |
| Fax |
|
| Email |
saurayapratapsingh1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar |
| Designation |
Associate Professor, Dept of Anesthesiology |
| Affiliation |
Heritage Institute of Medical Sciences,Varanasi |
| Address |
Room NO- 405, 4th Floor, Dept of Anesthesiology, Heritage Institute
of Medical Sciences, NH-2 Bypass, Bhadwar, Varanasi, UTTAR PRADESH 221311 INDIA
FLAT NO.401 GANPATI APARTMENT NAGAWA LANKA VARANSI UTTAR PRADESH 221005 INDIA
Varanasi
UTTAR PRADESH
221311
India |
| Phone |
8888832631 |
| Fax |
|
| Email |
aryanindia2003@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anil Kumar |
| Designation |
Associate Professor, Dept of Anesthesiology |
| Affiliation |
Heritage Institute of Medical Sciences,Varanasi |
| Address |
Room No. 405,4th Floor , Dept of Anesthesiology, Heritage Institute
of Medical Sciences, NH-2 Bypass, Bhadwar, Varanasi ,UTTAR PRADESH, 221311,India
FLAT NO.401 GANPATI APARTMENT NAGWA LANKA VARANASI UTTAR PRADESH 221005 INDIA
UTTAR PRADESH
221311
India |
| Phone |
8888832631 |
| Fax |
|
| Email |
aryanindia2003@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Heritage Institute Of Medical Sciences,NH-2,Bhadwar,Varanasi,Uttar Pradesh-221311 |
|
|
Primary Sponsor
|
| Name |
Heritage Institute of Medical SciencesNH BypassBhadwarvaranasiUttar PradeshIndia |
| Address |
NH-2 Bypass,Bhadwar,Varanasi,Uttar Pradesh, 221311 |
| Type of Sponsor |
Private 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 Sauraya Pratap Singh |
Heritage Institute of Medical Sciences, NH-2 Bypass,Bhadwar,Varanasi-221311 , Uttar Pradesh, INDIA |
Department of Anaesthesiology,
OT Complex, 4th Floor,
OT NO.- 6 ENT Operation Theater
Varanasi
UTTAR PRADESH |
8604443305
saurayapratapsingh1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J039||Acute tonsillitis, unspecified, (2) ICD-10 Condition: J039||Acute tonsillitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
0.3 mcg/kg Dexmedetomidine, diluted to 10 ml (i.v slow) given 15 min prior to the end of surgery |
| Intervention |
Ketamine |
Ketamine 0.5 mg/kg diluted up to 10 ml (i.v slow) and given 15 min prior to the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged ranged between 6 and 18 years belonging to ASA grade I scheduled for elective tonsillectomy |
|
| ExclusionCriteria |
| Details |
1) Children with Congenital anomalies, developmental problems, Inborn errors of metabolism, cerebral palsy, down syndrome.
2) Obese children with a risk of airway obstruction.
3) Patients with previous history of agitation after sevoflurane anesthesia and patients with respiratory distress of any cause.
4) Children with known allergy to any of the medications used.
5)Non willing patients.
6) Prolonged or any other complication during surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the efficacy of ketamine (0.5mg/kg) vs dexmedetomidine (0.3mcg/kg) for prevention of emergence agitation using PAED scale |
Immediately after emergence and at 10-minute,20-minute and 30-minute. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess pain intensity using FLACC scale(After extubation ,10 minute,20 minute & 30 minute).
Compare the hemodynamic stability (heart rate, blood pressure, oxygen saturation & respiratory rate) during emergence & postoperative period.
|
AT IMIIEDIATELY AFTER EMERGENCE, 10 Min,20 Min & 30 min. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
24/11/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
•Emergence
agitation (EA) is a phenomenon that includes restlessness, disorientation,
excitation, non-purposeful movement, inconsolability, thrashing, and
incoherence during early recovery from general anesthesia. The incidence of
Emergence agitation varies widely from approximately 0.25% to 90.5%, according
to age, assessment tool used, definitions, anaesthesia techniques, type of surgery, and time at
which Emergence agitation is assessed during recovery.
• The incidence of emergence agitation after sevoflurane anaesthesia
estimated at 80%. Emergence agitation occurs most frequently in preschool
children during the early stage of emergence from anaesthesia.
• Emergence agitation is commonly self-limited
and happens within first 30 min of
stay in a postanesthesia care
unit (PACU) and also can lead to disconnection of monitoring devices or
intravenous catheter, physical damage, falling, increase risk of bleeding. •Ketamine
is a N-methyl-D-aspartate (NMDA)
receptor antagonist with a strong analgesic effect if given in less than
anesthesia-induction dose . At small doses (<1 mg/kg), it does not cause
respiratory depression and has little effect on the heart rate and blood
pressure .
Dexmedetomidine is a
highly selective α2 adrenergic receptor agonist which
can produce pharmacological effects of anxiolysis, sedation, and analgesia without overt
respiratory and circulatory inhibition in a routine dose. Dexmedetomidine can
improve the cognitive function in children during recovery from general
anesthesia and contributes to dose-dependent inhibition of emergence
agitation after medical procedures . |