| CTRI Number |
CTRI/2025/11/097919 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
23/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) [Prospective Randomized study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to compare two different doses of dexmedetomidine to find out which is better in preventing restlessness in children after surgery under General Anaesthesia |
|
Scientific Title of Study
|
Comparison of effect of two different Dexmedetomidine infusion rates on emergence agitation in paediatric surgical patients receiving general anaesthesia with volatile anaesthetic agents |
| Trial Acronym |
CODE-PEA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harindra Kumar Goje |
| Designation |
Assoc Prof, Anaesthesiology and Trained in Paediatric Anaesthesiology |
| Affiliation |
INHS ASVINI |
| Address |
Dept of Anaesthesiology and Critical Care, INHS ASVINI
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8879711028 |
| Fax |
|
| Email |
hkgoje@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anoop Sharma |
| Designation |
Assoc Prof, Anaesthesiology and Paediatric Anaesthesiology |
| Affiliation |
INHS ASVINI |
| Address |
Dept of Anaesthesiology and Critical Care, INHS ASVINI
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8369847544 |
| Fax |
|
| Email |
anoopsharma.afmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devunuri Naresh |
| Designation |
Anaesthesia Resident |
| Affiliation |
INHS ASVINI |
| Address |
Dept of Anaesthesiology and Critical Care, INHS ASVINI
Mumbai
MAHARASHTRA
400005
India |
| Phone |
8466824584 |
| Fax |
|
| Email |
nareshdevunuri87@gmail.com |
|
|
Source of Monetary or Material Support
|
| INHS ASVINI, Near RC Church, Navy Nagar, Colaba, Mumbai, 400005. |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
INHS ASVINI, Near RC Church, Navy Nagar, Colaba, Mumbai, 400005. |
| 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 Harindra Kumar Goje |
INM INHS ASVINI |
Department of Anaesthesiology,
Mumbai
MAHARASHTRA |
08879711028
hkgoje@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF NAVAL MEDICINE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Dexmedetomidine 0.2 mcg/kg/hr infusion to prevent emergence agitation in children under general anaesthesia |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine 0.3 mcg/kg/hr infusion to prevent emergence agitation in children under general anaesthesia |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
(i) Age group 2 to 12 years
(ii) Both male and female patients
(iii) ASA grade I to II
(iv) Undergoing elective surgery in GA
|
|
| ExclusionCriteria |
| Details |
(i) Patients or Parents refusal to consent for the study
(ii) Patient with Respiratory and cardiac Diseases
(iii) Delayed Milestones
(iv) Patient with psychiatric disease
(v) ASA Grade III and above
(vi) Emergency surgery under GA
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study aims to provide evidence on whether a lower infusion rate (0.2 mcg/kg/hr) is as effective as a slightly higher rate (0.3 mcg/kg/hr) in preventing EA, while minimizing hemodynamic instability. The results could guide pediatric anesthesia practice by optimizing dexmedetomidine dosing protocols, improving patient safety, enhancing recovery profiles and reducing perioperative complications related to EA. |
Interim Assessments after every 06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparison of duration of recovery in each group
2. Adverse events in each group |
Interim Assessments after every 06 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2025 |
| 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="1" |
|
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
|
This prospective randomized study aims to compare two dexmedetomidine infusion rates 0.2 and 0.3 micrograms per kilogram per hour for preventing emergence agitation in children aged two to twelve years undergoing general anesthesia One hundred patients will be divided into two equal groups and given standardized anesthesia using volatile agents Emergence agitation and pain will be assessed using clinical scales in the postoperative period The study will compare the incidence severity recovery time and adverse effects including bradycardia hypotension and desaturation to identify the optimal infusion rate that ensures effective prevention of emergence agitation with stable hemodynamic parameters |