| CTRI Number |
CTRI/2025/08/093692 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study if intranasal dexmedetomidine is better than intravenous dexmedetomidine in reducing postoperative delirium in children undergoing elective surgery. |
|
Scientific Title of Study
|
Intranasal versus Intravenous Dexmedetomidine for reducing emergence delirium in paediatric patients undergoing sevoflurane based anaesthesia A comparative double-blinded randomized 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 |
Asad Reza |
| Designation |
Junior Resident |
| Affiliation |
IGIMS Patna |
| Address |
Dept of Anesthesiology and CCM
Ward Block 1st floor
IGIMS Sheikhpura Patna
Patna
BIHAR
800014
India |
| Phone |
7982825349 |
| Fax |
|
| Email |
nasarasad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nitin Kumar |
| Designation |
Assistant Professor |
| Affiliation |
IGIMS Patna |
| Address |
Dept of Anesthesiology and CCM
Ward Block 1st floor
IGIMS Sheikhpura Patna
Patna
BIHAR
800014
India |
| Phone |
8076070302 |
| Fax |
|
| Email |
kumarnitin516@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asad Reza |
| Designation |
Junior Resident |
| Affiliation |
IGIMS Patna |
| Address |
Dept of Anesthesiology and CCM
Ward Block 1st floor
IGIMS Sheikhpura Patna
Patna
BIHAR
800014
India |
| Phone |
7982825349 |
| Fax |
|
| Email |
nasarasad@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IGIMS Patna |
| Address |
Dept of Anesthesiology and CCM
Ward Block 1st floor
IGIMS Sheikhpura Patna |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Asad Reza |
Dept of Anesthesiology and CCM
Ward Block 1st floor
IGIMS Sheikhpura Patna |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asad Reza Dr Nitin Kumar |
IGIMS Patna |
Pediatric OT PACU unit Ward Block 1st floor Department of Anesthesiology and CCM
Patna
BIHAR |
7982825349
nasarasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IGIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q620||Congenital hydronephrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intranasal instillation of dexmedetomidine drops in children undergoing elective surgery. |
Group A patients will receive intranasal dexmedetomidine at a dose of 1 µg/kg 30 minutes before surgery.
Group B patients will receive intravenous dexmedetomidine at a dose of 0.5 µg/kg over 10 minutes post-induction.
For the study, the intranasal dose is typically administered as nasal drops which is delivered slowly into the nostrils using a syringe without a needle.
Emergence Delirium will be compared in each group of children, using Aonos 4 point scale. |
| Comparator Agent |
Patients will receive intravenous dexmedetomidine at a dose of 0.5 µg/kg over 10 minutes post-induction. |
The dexmedetomidine solution is diluted with normal saline to a fixed volume i.e. 0.5 mL in Group A while 10 ml in Group B, so that all children receive the same volume regardless of weight, masking dose differences. The exact dose is prepared by an independent staff member not involved in patient care or assessment to maintain double blinding17,18.
Blinding across different weights is achieved by standardizing the total volume administered, diluting the drug accordingly and using independent preparation to conceal dose differences.
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged between 2 to 8 years.
2. Children with ASA grade I/II.
3. Children undergoing elective pediatric surgery.
4. Patient’s guardians willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patient’s guardians refusal to participate.
2.Children with allergy to dexmedetomidine.
3.Children with history of URTI.
4.Children with history of nasal obstruction.
5.Children with history of seizures.
6.Children with history of any cardiac problems.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of preoperative agitation (As per Aonos 4 point scale)
1-calm
2-not calm, but could be easily calmed
3- moderately agitated or restless
4- combative, excited, and disoriented.
Intransal dexmedetomidine may be more convenient to use and of similar efficacy as compared to intravenous dexmedetomidine.
|
Level of emergence delirium (As per PAED score): After extubation, leaving the operating room, after 10 minutes in PACU, after 20 minutes in PACU, after 30 minutes in PACU, after 40 minutes in PACU. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters HR, MAP, sPO2, ETCO2 at before injection, after injection, 5 minutes after start of surgery, 10 minutes after start of surgery, 15 minutes after start of surgery, 20 minutes after start of surgery, after extubation, before transferring to recovery, when arriving at the recovery, in 2nd 10 minutes of recovery, in 3rd 10 minutes of recovery.
Frequency of ondansetron prescription. |
5 minutes after start of surgery, 10 minutes after start of surgery, 15 minutes after start of surgery, 20 minutes after start of surgery, after extubation, before transferring to recovery, when arriving at the recovery, in 2nd 10 minutes of recovery, in 3rd 10 minutes of recovery. |
|
|
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)
|
01/09/2025 |
| 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 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
|
Patients scheduled for elective surgery will be enrolled in the study after obtaining written informed consent. Participants will be randomly assigned to one of two groups—Group A (intranasal dexmedetomidine) or Group B (intravenous Dexmedetomidine)—with 50 patients in each group. Randomization will be performed using a computer-generated sequence in a 1:1 ratio, with allocation concealment ensured by sequentially numbered, opaque, sealed envelopes. · Group A: Patients will receive intranasal dexmedetomidine at a dose of 1 µg/kg 30 minutes before surgery. · Group B: Patients will receive intravenous dexmedetomidine at a dose of 0.5 µg/kg over 10 minutes post-induction. |