| CTRI Number |
CTRI/2025/02/080731 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study the Effect of Ketamine and Dexmedetomidine for Sedation in children ear surgery. |
|
Scientific Title of Study
|
Study to evaluate the effects of Inj Ketamine and Inj Dexmedetomidine for Sedation in Pediatric Middle Ear Cleft Surgery. |
| Trial Acronym |
PEDK |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Jalaun( Orai) |
| Address |
Department of Anesthesia
Type 3 Block H Room Number 8, GMC Jalaun(Orai)
Kalpi Road
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9454224498 |
| Fax |
|
| Email |
dranilkumarucr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Jalaun(Orai) |
| Address |
Room Number 8, Type 3 Block H, GMC Jalaun(Orai)
Uttar Pradesh
India
Kalpi Road
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9454224498 |
| Fax |
|
| Email |
dranilkumarucr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anil Kumar |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Jalaun( Orai) |
| Address |
Room Number 8,Type 3 Block H, GMC Jalaun(Orai)
Uttar Pradesh
India
Kalpi Road
Jalaun
UTTAR PRADESH
285001
India |
| Phone |
9454224498 |
| Fax |
|
| Email |
dranilkumarucr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anil Kumar |
| Address |
Room Nmber 8 Block H Type 3 GMC Jalaun(Orai)
285001 Uttar Pradesh
India |
| Type of Sponsor |
Other [self] |
|
|
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 Anil Kumar |
Rajkiya Medical college , Orai, Jalaun |
OT Complex, Department of Anesthesia , Ground Floor Room NO, 2
PIN 285001
Uttar Pradesh
India
Jalaun
UTTAR PRADESH |
9454224498
dranilkumarucr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMC Jalaun(Orai) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H722||Other marginal perforations of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Dexmedetomidine |
1-2 Microgram per kg body weight , IV, bolus dose, followed by continues infusion at 1-2microgram per kg per hour |
| Comparator Agent |
Inj Ketamine
Inj Dexmedetomidine |
Inj Ketamine 1-2 mg/kg Body Weight bolus, supplemental bolus dose .5 mg per kg as needed
Inj Dexmedetomidine 1 microgram per kg in initiation as bolus then infusion at 1-2 microgram per kg per hour |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
perforation of tympanic membrane |
|
| ExclusionCriteria |
| Details |
1 congenital life threatening condition
2 IHD or other cardiac condition
3 chronic renal diseases
4 anemia and blood cancer
5 peripheral vascular disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare level of Sedation achieved by Ramsay Sedation Scale Score |
Baseline, 6 hours and 8 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Hemodynamic Changes
2 Rescue Analgesia |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dranilkumarucr@gmail.com].
- For how long will this data be available start date provided 14-07-2025 and end date provided 14-08-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
in this study dexmedetomidine is compared with ketamine for middle ear surgery in pediatric patients. when used alone they show some properties, but when used together they show additional benefits, which is studied with the help of Ramsay sedation scale as primary objective. in secondary objectives, we look for the hemodynamic stability, requirement of rescue analgesia and occurrence of any complication in both groups |