| CTRI Number |
CTRI/2025/11/097622 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find if using Vecuronium, a neuromuscular blocking agent can make intubation easy among children in Pediatric Emergency |
|
Scientific Title of Study
|
Role of Neuromuscular blocking agent Vecuronium in improving the first pass success of intubation in Pediatric Emergency An open label Randomised Controlled 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 |
Asha Jyothi Penugonda |
| Designation |
Senior resident |
| Affiliation |
AIIMS, Raipur |
| Address |
Dr. Asha Jyothi Penugonda
Department of Pediatrics,
B Block third floor,
AIIMS Raipur,
Chhattisgarh-492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
8220639570 |
| Fax |
|
| Email |
asha.penugonda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Santosh K Rathia |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, Raipur |
| Address |
Dr. Santosh K Rathia
Department of Emergency and Trauma,
AIIMS Raipur,
Chhattisgarh-492010
CHHATTISGARH
492010
India |
| Phone |
9891611996 |
| Fax |
|
| Email |
drsantoshrathia@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Asha Jyothi Penugonda |
| Designation |
Senior resident |
| Affiliation |
AIIMS, Raipur |
| Address |
Dr. Asha Jyothi Penugonda
Department of Pediatrics,
B Block third floor,
AIIMS Raipur,
Chhattisgarh-492010
CHHATTISGARH
492010
India |
| Phone |
8220639570 |
| Fax |
|
| Email |
asha.penugonda@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Raipur Chhattisgarh India 492010 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Asha Jyothi Penugonda |
All India Institute of Medical Sciences Raipur |
3rd Floor, B Block
(Administrative block)
Department of Pediatrics
Division of Pediatric emergency
All India Institute of Medical Sciences
Tatibandh
Raipur
Chhattisgarh
492010
Raipur
CHHATTISGARH |
8220639570
asha.penugonda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstituteEthicsCommitteeAIIMSRaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
sedoanalgesia with ketamine and or or midazolam |
Children of age group between 1 month to 14 years presenting to Paediatric emergency planned for intubation will be enrolled in the study and they will be allocated to the two groups by computer generated, block random allocation, after child satisfies the inclusion criteria.
STUDY GROUP A- Intubation will be done with sedoanalgesics and NMBA – Vecuronium.
STUDY GROUP B- Intubation without NMBA; Intubation will be with induction agents as per standard guidelines with sedative and analgesics.
|
| Intervention |
Vecuronium with seodanalgesia with ketamine and or or midazolam |
Children of age group between 1 month to 14 years presenting to Paediatric emergency planned for intubation will be enrolled in the study and they will be allocated to the two groups by computer generated, block random allocation, after child satisfies the inclusion criteria.
STUDY GROUP A- Intubation will be done with sedoanalgesics and NMBA – Vecuronium.
STUDY GROUP B- Intubation without NMBA; Intubation will be with induction agents as per standard guidelines with sedative and analgesics.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of age group between 1month to 14 years presenting to Paediatric emergency planned for intubation. |
|
| ExclusionCriteria |
| Details |
1. Anticipated Difficult airway (anatomical)
2. Syndromic children
3. Children with neuromuscular disorders
4. Children with crush injuries
5. History of anaphylaxis to any NMBA
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the Role of Neuromuscular Blocking Agent, Vecuronium in improving the first pass success of intubation in Pediatric emergency |
Baseline during intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1To compare the ease of ventilation at intubation with without NMBA using a validated score Vibymogensen score
2 To compare the number of intubation attempts with & without NMBA including first pass success
3 To assess the time taken for intubation with & without NMBA
4 To assess the hemodynamic status & complications during intubation at intubation with & without NMBA
|
Baseline during intubation |
|
|
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)
|
01/12/2025 |
| 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
|
The use of a
neuromuscular-blocking during intubation can improve the quality as well as the
success rate of tracheal intubation, better hemodynamic stability during
induction of anesthesia, lower prevalence of hypoxemia and procedure-related
complications Usage of NMBA was
also associated with reduced complications and respiratory arrest
or cardiovascular collapse Studies have shown to improve the odds of
improving FPS at intubation with usage of NMBA and better ease of intubation
with usage of NMBA in adults and children However there is no consensus existing
regarding the use of NMBA in children so far. Hence we have planned this study
to assess the first pass success with NMBA and associated factors which will
ease the intubation in children
METHODS OF THE STUDY Children
of age group between 1 month to 14 years presenting to Paediatric emergency
planned for intubation will be enrolled in the study and they will be allocated
to the two groups by computer generated block random allocation after child
satisfies the inclusion criteria STUDY GROUP A Intubation will be done
with sedoanalgesics and NMBA Vecuronium
STUDY GROUP B Intubation without
NMBA Intubation will be with induction agents as per standard guidelines with
sedative and analgesics
EXPECTED DURATION OF THE STUDY is 18 months
|