| CTRI Number |
CTRI/2025/02/079982 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of two different doses of Dexmedetomidine versus Nalbuphine in attenuation of Sevoflurane associated emergence agitation in
paediatric patients undergoing hypospadias repair
|
|
Scientific Title of Study
|
Comparison of two different doses of Dexmedetomidine
versus Nalbuphine in attenuation of Sevoflurane associated emergence agitation in
paediatric patients undergoing hypospadias repair- a hospital based randomised controlled trial
|
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tejasvini Kalathuru |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Belagavi, Karnataka, India-590010 |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Belagavi, Karnataka,India-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9962728749 |
| Fax |
|
| Email |
tejureddy.kalathuru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahantesh S M |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Belgaum, Karnataka, India-590010 |
| Address |
Department of Anaesthesiology Jawaharlal Nehru Medical College, Belagavi, Karnataka, India- 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9962728749 |
| Fax |
|
| Email |
drmontygoudar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejasvini Kalathuru |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College , Belgaum, Karnataka, India-590010 |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College ,Belagavi,Karnataka, India-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9962728749 |
| Fax |
|
| Email |
tejureddy.kalathuru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Jawaharlal Nehru Medical College, KAHER, Nehru Nagar, Belagavi, Karnataka, India-590010 |
|
|
Primary Sponsor
|
| Name |
Dr Tejasvini Kalathuru |
| Address |
DR PRABHAKAR KORE HOSPITAL, KLES, NAHRU NAGAR, BELGAUM-590010 |
| Type of Sponsor |
Other [post graduate student] |
|
|
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 Tejasvini K |
Dr Prabhakar Kore Hospital, Nehru Nagar, Belgaum |
Pediatric Operating room, Department of Anaesthesia,Jawaharlal Nehru Medical College,Belagavi-590010
Belgaum
KARNATAKA |
9962728749
tejureddy.kalathuru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N99||Intraoperative and postproceduralcomplications and disorders of genitourinary system, not elsewhere classified, (2) ICD-10 Condition: N99||Intraoperative and postproceduralcomplications and disorders of genitourinary system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of 2 different doses of Dexmedetomidine and 1 dose of nalbuphine in the attenuation of emergence agitation from sevoflurane anaesthesia |
Two different doses of Dexmedetomidine (0.3mcg/kg, 0.5mcg/kg) and nalbuphine (0.1mg/kg) is administered 20 mins prior to the end of the procedure and assessed for emergence agitation from sevoflurane. |
| Comparator Agent |
Administration of 2 different doses of Dexmedetomidine and 1 dose of nalbuphine in the attenuation of emergence agitation from sevoflurane anaesthesia |
Two different doses of Dexmedetomidine (0.3mcg/kg, 0.5mcg/kg) and nalbuphine (0.1mg/kg) is administered 20 mins prior to the end of the procedure and assessed for emergence agitation from sevoflurane. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Male |
| Details |
1. ASA physical status I and II.
2. Age between 2 to 10 years.
3. Patients undergoing lower abdominal surgeries
4. Operation time less than or equal to 1 hour. |
|
| ExclusionCriteria |
| Details |
1. Risk of aspiration
2. Known difficult airway
3. Patients with Upper and Lower respiratory tract infections
4. Congenital malformations involving respiratory tract
5. History of epilepsy
6. Patients with cardiac, renal or liver diseases
7. Patients with allergy to the study drug
8. Cervical spine disease
9. Patients with bleeding and coagulation disorders
10. Patients receiving digoxin
11. Preoperatively agitated child |
|
|
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 effects of 0.3 mcg/kg of Dexmedetomidine IV , 0.5 mcg/kg of
Dexmedetomidine IV versus 0.1 mg/kg of Nalbuphine IV in attenuation of emergence
agitation resulting from the use of Sevoflurane, in paediatric patients undergoing
Hypospadias repair. |
BASELINE VALUE
0 MIN IN PACU
5 MIN
10 MIN
20 MIN
30 MIN
40 MIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the Ramsay sedation score and Pain score of 0.3 mcg/kg Dexmedetomidine
IV, 0.5mcg/kg Dexmedetomidine IV and 0.1 mg/kg Nalbuphine IV and their post
operative hemodynamic parameters. |
BASELINE VALUE
0 MIN IN PACU
5 MIN
10 MIN
20 MIN
30 MIN
40 MIN |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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 4 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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="0"
Months="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [tejureddy.kalathuru@gmail.com].
- For how long will this data be available start date provided 29-10-2024 and end date provided 03-02-2032?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
it is a novel study comparing the effects of two different doses of dexmedetomidine versus one dose of nalbuphine on the emergence agitation that occurs with the use of inhalational agent such as sevoflurane in paediatric patients undergoing hypospadias repair under general anaesthesia with laryngeal mask airway and caudal epidural anaesthesia. it shall provide valuable insight on effects of both drugs on the said condition and their optimal dosages in reducing the incidence of sevoflurane associated emergence agitation in paediatric patients posted for hypospadias repair. |