| CTRI Number |
CTRI/2025/08/093289 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the requirement of extra anesthetic medications after a nasal medication for kids undergoing endoscopy |
|
Scientific Title of Study
|
To study the requirement of intravenous propofol after premedication with intranasal ketamine and dexmedetomidine in pediatric patients undergoing upper GI endoscopy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jasmin Bulbul |
| Designation |
SR ORGAN TRANSPLANT ANESTHESIA |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesiology and critical care , ILBS, New Delhi
ILBS, D1 ,Vasant Kunj , New Delhi
New Delhi
DELHI
110070
India |
| Phone |
7077703933 |
| Fax |
|
| Email |
doc.jasmin25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jasmin Bulbul |
| Designation |
SR ORGAN TRANSPLANT ANESTHESIA |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesiology and critical care , ILBS, New Delhi
ILBS, D1 ,Vasant Kunj , New Delhi
New Delhi
DELHI
110070
India |
| Phone |
7077703933 |
| Fax |
|
| Email |
doc.jasmin25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jasmin Bulbul |
| Designation |
SR ORGAN TRANSPLANT ANESTHESIA |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Department of Anaesthesiology and Critical Care , ILBS, New Delhi
ILBS, D1 ,Vasant Kunj , New Delhi
New Delhi
DELHI
110070
India |
| Phone |
7077703933 |
| Fax |
|
| Email |
doc.jasmin25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, ILBS , NEW DELHI |
|
|
Primary Sponsor
|
| Name |
Investigator Dr Jasmin Bulbul |
| Address |
Department of Anaesthesiology and Critical Care , ILBS, New Delhi ,110070 |
| Type of Sponsor |
Research institution |
|
|
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 |
| DrJasmin Bulbul |
ILBS, new delhi |
ILBS,D1,VASANT KUNJ ,NEW DELHI
South
DELHI |
07077703933
doc.jasmin25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K743||Primary biliary cirrhosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Premedication |
Premedication with intranasal ketamine 4mg/kg and dexmedetomidine 2microgram/kg once before upper GI endoscopy, duration will be around 60 seconds |
| Comparator Agent |
Premedication |
To compare the anesthetic drug requirement after premedication with intranasal ketamine and dexmedetomidine in study group and intranasal distilled water in comparator group |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing upper GI Endoscopy
2.parents agreeing to participate in study
3.Adequate NPO status |
|
| ExclusionCriteria |
| Details |
Inadequate NPO status
Known allergy to given drugs
Vascular disorders like NCPF ,EHPVO, Budd chiari syndrome
Massive ascitis
H/O upper airway obstruction, severe respiratory disease, or congenital heart disease
Patients with H/O developmental delay or behavioral disorders
Parental refusal to participate in 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 |
| To compare the dosage of intravenous propofol after premedication with intranasal dexmedetomodine and ketamine and induction with IV propofol and ketamine during upper GI Endoscopy. |
To compare the dosage of intravenous propofol after premedication with intranasal dexmedetomodine and ketamine and induction with IV propofol and ketamine during upper GI Endoscopy at 10 minutes , 15 minutes , 20 minutes during endoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
|
1.Hemodynamics- HR, BP , SPO2
2.Sedation score,
3.Parental separation score.
4.Any adverse effects like desaturation, bradycardia |
At 5 minutes, 10 minutes,15 minutes, after the premedication & every 5 minutes during endoscopy |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/08/2025 |
| 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="0"
Months="6"
Days="10" |
|
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
|
In this study pediatric patients aged 1 to 5 years will be given intranasal premedication with ketamine and dexmedetomidine 30 minutes before undergoing upper GI endoscopy. All the vitals will be noted and the sedation score and anxiety score will be noted. The the patient will be shifted to endoscopy suite, Heart rate , BP, SPO2 will be noted . All the patients will be given induction dose of propofol 1mg/kg IV and ketamine 1mg/kg IV will be given. Further doses will be given on patient movement as per anesthesiologist’s discreetion.After the procedure the vitals will be note and the patient will be shifted when awake. Any adverse event like desaturation or bradycardia will be noted |