| CTRI Number |
CTRI/2025/01/078947 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of intravenous drugs like Nalbuphine, Ketamine and Dexmedetomidine for the prevention of a state of confusion and restlessness that can occur in children after waking up from general anesthesia who were posted for adenotonsillectomy |
|
Scientific Title of Study
|
Effectiveness of low dose intravenous dexmedetomidine,ketamine and nalbuphine in preventing emergence agitation after sevoflurane anaesthesia in children undergoing Adenotonsillectomy, A randomized 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 Chandra Prithwish Prawir |
| Designation |
1st year post graduate |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of anaesthesiology First floor A block Aarupadai veedu medical college and hospital Kirumambakkam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8586091560 |
| Fax |
|
| Email |
prithwishchandra50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E Shanmugavalli |
| Designation |
Professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of anaesthesiology First floor A block Aarupadai veedu medical college and hospital Kirumambakkam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
vallijegan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C Rajesh Prabhu |
| Designation |
Associate professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
Department of anaesthesiology First floor A block Aarupadai veedu medical college and hospital Kirumambakkam, Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9843360106 |
| Fax |
|
| Email |
cr.prabhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology First floor A block Aarupadai veedu medical college and hospital
Kirumambakkam Pondicherry Pondicherry PONDICHERRY 607402 India |
|
|
Primary Sponsor
|
| Name |
Aarupadai veedu medical college and hospital |
| Address |
Aarupadai veedu medical college and hospital Kirumampakkam
Pondicherry cuddalore highway Pondicherry |
| 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 Chandra Prithwish Prawir |
Aarupadai veedu medical college and hospital |
Department of
Anaesthesiology First
floor A block
Kirumampakkam
Cuddalore pondicherry
highway Pondicherry
Pondicherry
PONDICHERRY
Pondicherry
PONDICHERRY |
8586091560
prithwishchandra50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee aarupadai veedu medical college and hospital |
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 |
Emergence agitation |
PAED score
FLACC score
PACU score |
| Comparator Agent |
Group A patients will receive Inj Dexmedetomidine |
Group A patient will be receaving low dose 0.25mcg/kg of Inj Dexmedetomidine iv diluted into 10ml of sterile water after 15 minutes of induction |
| Comparator Agent |
Group B patients will receive inj Nalbuphine |
Group B patient will be receaving low dose 0.1ml/kg of inj Nalbuphine iv diluted into 10ml of sterile water after 15 minutes of induction |
| Comparator Agent |
Group C patients will receive inj Ketamine |
Group C patient will be receaving low dose 0.25mg/kg of inj Ketamine iv diluted into 10ml of sterile water after 15 minutes of induction |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
Age 3 to 10 years
weight 15 to 35 kg
Duration of procedure 60 to 90 minutes |
|
| ExclusionCriteria |
| Details |
Physical developmental delay
Consent refusal from parents
Bleeding disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of low dose intravenous Dexmedetomidine, Ketamine and Nalbuphine in preventing emergence agitation by assessing pediatric anesthesia emergence delirium (PAED) score after extubation in postoperative period. |
4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor hemodynamics intraoperatively , at extubation and postoperatively. |
15 minutes |
| To measure and compare sedation post operatively using Ramsay Sedation scale |
10 minutes
20 minutes
30 minutes |
| To assess post operative Analgesic effect using Face, Leg, Activity, Cry and Consolability (FLACC) scale |
10 minutes
20 minutes
30 minutes |
| To observe complications like postoperative nausea and vomiting, Bradycardia, Coughing, Laryngospasm |
4 hours |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
28/01/2025 |
| 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="6"
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
|
One of the most common problem in children receiving Sevoflurane based anaesthesia while undergoing Adenotonsillectomy is emergence agitation. It can induce potential problems in children such as self injury, disconnection of the intravenous line , cough, stridor and bleeding which can cause difficulties for medical staff and serious anxiety for family members in the postoperative period. In our study we are going to evaluate the effectiveness of low dose intravenous Dexmedetomidine versus Nalbuphine versus Ketamine for the prevention of Emergence agitation. |