| CTRI Number |
CTRI/2024/04/066425 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of two different doses of Dexmedetomidine and observing for which dose has a moresignificant decrease in the agitation resulting from Sevoflurane usage in Paediatric patients posted for lower Abdominal Surgeries |
|
Scientific Title of Study
|
Comparison of two different doses of Dexmedetomidine in attenuation of Sevoflurane associated Emergence Agitation in paediatric patients posted for lower abdominal surgeries A Hospital based Randomised Controlled 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 Tejasvini Kalathuru |
| Designation |
Junior Resident |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE, BELAGAVI |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9962728749 |
| Fax |
|
| Email |
tejureddy.kalathuru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahantesh S Mudankanagoudar |
| Designation |
Professor |
| Affiliation |
KLE Dr. Prabhakar Kore Hospital and MRC |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7829164500 |
| Fax |
|
| Email |
drmontygoudar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahantesh S Mudakangoudar |
| Designation |
Professor |
| Affiliation |
KLE Dr. Prabhakar Kore Hospital and MRC |
| Address |
DEpartment of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
7829164500 |
| Fax |
|
| Email |
drmontygoudar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi |
|
|
Primary Sponsor
|
| Name |
DrTejasvini Kalathuru |
| Address |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrTejasvini Kalathuru |
KLE Dr. Prabhakar Kore Hospital |
Department of Anaesthesiology
Jawaharlal Nehru Medical College
Belagavi
Belgaum
KARNATAKA |
9962728749
tejureddy.kalathuru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
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 |
Administration of dexmedetomidine |
comparison of two different doses of dexmedetomidine
(0.3mcg/kg and 0.5mcg/kg) administered via intravenous route as an infusion over 10 mins to look for attenuation of sevoflurane associated emergence agitation in pediatric patients undergoing lower abdominal surgeries under general anaesthesia using laryngeal mask airway and caudal anaesthesia. |
| Comparator Agent |
administration of dexmedetomidine |
comparison of two different doses of dexmedetomidine
(0.3mcg/kg and 0.5mcg/kg) administered via intravenous route as an infusion over 10 mins to look for attenuation of sevoflurane associated emergence agitation in pediatric patients undergoing lower abdominal surgeries under general anaesthesia using laryngeal mask airway and caudal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I and II.
Age between 2 to 10 years.
Patients undergoing lower abdominal surgeries
Operation time less than or equal to 1 hour. |
|
| ExclusionCriteria |
| Details |
risk of aspiration
known difficult airway
Patients with Upper respiratory tract infections
congenital malformations involving respiratory tract
History of epilepsy
Patients with cardiac, renal or liver diseases
Patients with allergy to the study drug
cervical spine disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare effects of 0.3 mcg/kg and 0.5mcg/kg of dexmedetomidine in attenuation
of emergence agitation in paediatric patient maintained on Sevoflurane, undergoing
lower abdominal surgeries. |
after surgery
10 mins
20 mins
30 mins
40 mins
50 mins
1 hour
every 1 hour until 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameter assessment for 24 hours after administration of study drug. |
every 1 hour until 24 hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/05/2024 |
| 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="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
|
its a novel study comparing the effects of two different doses of dexmedetomidine on the emergence agitation with the use of inhalational agent such as sevoflurane in pediatric patients undergoing lower abdominal surgeries performed under general anesthesia with a laryngeal mask airway and caudal anesthesia. it shall provide valuable insight on the usage of the optimal dexmedetomidine dose to avoid or reduce the incidence of sevoflurane associated emergence agitation in pediatric patients. |