| CTRI Number |
CTRI/2025/02/080412 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Dexmedetomidine versus Fentanyl as Premedication in Pediatric Patients in general anaesthesia |
|
Scientific Title of Study
|
A comparative study of the efficacy of Dexmedetomidine versus Fentanyl as Premedication in Pediatric Patients via intranasal mucosal atomization device. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Modi |
| Designation |
Resident doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9909430593 |
| Fax |
|
| Email |
modirohan3021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Kishnani |
| Designation |
Associate Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9898076139 |
| Fax |
|
| Email |
drpriya0809@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Kishnani |
| Designation |
Associate Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9898076139 |
| Fax |
|
| Email |
drpriya0809@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, waghodiya, pipariya, vadodara, gujarat, india. pincode-391760 |
|
|
Primary Sponsor
|
| Name |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Waghodiya, Piparia ,Vadodara,GUJARAT,391760 |
| 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 Priya Kishnani |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Sumandeep
vidyapeeth Wagodhia ,
Pipariya, Vadodara
Wagodhia , Pipariya,
Vadodara Vadodara
GUJARAT 391760
India
Vadodara
GUJARAT
Vadodara
GUJARAT |
9898076139
drpriya0809@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth 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 |
dexmedetomidine |
1.5 ug/kg dose given to the patient 30 min prior surgery and observe the response |
| Comparator Agent |
Fentanyl |
1 ug/kg dose given to patient 30 min prior to surgery and check the response |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children in the age group 3–12 years
ASA I and II.
Children undergoing elective surgery under general anesthesia. |
|
| ExclusionCriteria |
| Details |
Children with ASA physical status Classes III and IV
Allergy to the drugs under study
Patients with any intranasal pathology/congenital anomaly of upper airway tract
Patients on anticonvulsant therapy or other sedative medications
Patients undergoing emergency surgeries.
Children with bradycardia
Patient fulfilling the above said inclusion criteria will be subjected to study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will help us to know which drug out of two drugs - intranasal fentanyl or
dexmedetomidine is a better premedication to achieve the better-quality sedation and reducing
preoperative anxiety in children |
every 5 min till 30 min (pre ot)
every 30 min till 2 hours (intra ot) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
following parameters will be assessed.
1)Anxiety score
2)acceptance of drug
3)level of sedation
4)behaviour at the time of parent separation
|
every 5 min till 30 min (pre ot)
every 30 min till 2 hours (intra ot) |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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
|
A comparative study of the efficacy of Dexmedetomidine versus Fentanyl as Premedication in Pediatric Patients via intranasal mucosal atomization device. To compare the efficacy of intranasal fentanyl and intranasal dexmedetomidine, for relieving pre-operative anxiety in children on the basis of onset and quality of anxiolysis parental separation hemodynamic stability cooperation to mask holding To compare the onset of action and duration of the sedative effects of each drug To evaluate the safety of both intranasal fentanyl and intranasal dexmedetomidine as premedication, focusing on the incidence of adverse effects.
Inclusion Criteria: Children in the age group 3–12 years. ASA I and II. Children underwent elective surgery under general anesthesia
Exclusion Criteria: Children with ASA physical status Classes III and IV Allergy to the drugs under study Patients with any intranasal pathology/congenital anomaly of upper airway tract Patients on anticonvulsant therapy or other sedative medications Patients undergoing emergency surgeries. Children with bradycardia Patient fulfilling the above said inclusion criteria will be subjected to study.
Patient will be divided randomly in group D and group F: Group - D - 1.5 ug/kg intranasally ½dose in each nostril. Group - F - 1 ug/kg intranasally 1/5 dose in each nostril.
Duration Of Study: 18 Months
Study Site: Dhiraj Hospital, S.B.K.S M.I.R.C. Piparia, Waghodia, Vadodara, Gujarat. Study Design: Randomised, parellel group, active controlled trial
Sample Size: 60 (30 In Each Group) |