| CTRI Number |
CTRI/2025/06/088569 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Propofol vs midazolam for sedation in acutely ill mechanically ventilated children |
|
Scientific Title of Study
|
Propofol vs midazolam for sedation in acutely ill mechanically ventilated children (PROPOSE): A randomized controlled trial |
| Trial Acronym |
PROPOSE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Meena |
| Designation |
DM Senior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Pediatric Intensive Care Unit,
Department of Pediatrics,
Advanced Pediatric Centre,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7827135073 |
| Fax |
|
| Email |
docpriya.mamc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree M |
| Designation |
Professor and Chief |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Division of Pediatric Emergency and Intensive Care,
Department of Pediatrics,
Advanced Pediatric Centre,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815594343 |
| Fax |
|
| Email |
mjshree@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashree M |
| Designation |
Professor and Chief |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Division of Pediatric Emergency and Intensive Care,
Department of Pediatrics,
Advanced Pediatric Centre,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815594343 |
| Fax |
|
| Email |
mjshree@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research (PGIMER),
Madhya Marg,
Sector 12,
Chandigarh, India.
Pin code: 160 012 |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of medical education and research |
| Address |
PGIMER, Sector 12
Madhya Marg
Chandigarh-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priyanka Meena |
Postgraduate Institute of Medical Education and Research |
Pediatric Intensive Care Unit,
APC 3 B,
Department of Pediatrics
Chandigarh
CHANDIGARH |
7827135073
docpriya.mamc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Midazolam |
After an initial midazolam bolus of 0.1mg/kg, children will be started on midazolam at 2 mcg/kg/min, using a peripheral or a central venous access. Dose will be titrated, based on the RASS score by the primary investigator or the treating resident doctor. Midazolam infusion will be increased by 1 mcg/kg/min every 30 minutes till a maximum dose of 4 mcg/kg/min till the target RASS score is reached. |
| Intervention |
Propofol |
After an initial propofol bolus of 1mg/kg to achieve steady-state plasma concentration, children will be started on propofol at 1 mg/kg/hr, using a peripheral or a central venous access. Dose will be titrated, based on the RASS score by the primary investigator or the treating resident doctor. Propofol infusion will be increased by 1 mg/kg/hr every 30 minutes till a maximum dose of 4 mg/kg/hr till the target RASS score is reached. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Acutely ill children mechanically ventilated in PICU and expected to remain ventilated for at least 12 hours after enrolment |
|
| ExclusionCriteria |
| Details |
Children on infusion of sedative drugs for more than 12 hours
Significant hemodynamic instability (Vasoactive inotropic score more than 40) and not stabilized after appropriate intravenous volume replacement and vasoactives
Primary cardiogenic shock
Known pre existing neuromuscular or mitochondrial disorder
Conditions requiring midazolam infusion like status epilepticus, status dystonicus, tetanus, etc
Pancreatitis
Post cardiac arrest state
Raised intracranial pressure
Profound encephalopathy due to the primary disease which can hinder assessment of level of sedation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of time spent in the targeted sedation level in the first 72 hours after randomization |
Till 72 hours after randomization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for top-up doses of midazolam, propofol, fentanyl, and vecuronium |
Till 72 hours after randomization |
| 28 day ventilator free days |
Till 28 days after randomization |
| Length of PICU and hospital stay |
From randomization till the time of discharge from PICU or hospital |
| 28 day mortality |
Till 28 days after randomization |
| Treatment failure rate |
Till 72 hours after randomization |
| Incidence of extubation failure |
Till 28 days after randomization |
| Incidence of adverse events related to sedation |
Till 72 hours after randomization |
| Incidence of occurrence of iatrogenic withdrawal syndrome and ICU delirium |
Till 28 days after randomization |
|
|
Target Sample Size
|
Total Sample Size="292"
Sample Size from India="292"
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 |
|
Date of First Enrollment (India)
|
21/06/2025 |
| 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 - 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
Response - Statistical Analysis Plan
Response - Informed Consent Form
- 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 (Others) - The datasets used and analysed during the study shall be available from the corresponding author (docpriya.mamc@gmail.com) on reasonable request.
- For how long will this data be available start date provided 01-11-2026 and end date provided 31-10-2031?
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
|
Acutely ill children aged 1 – 12 years mechanically ventilated in PICU and expected to remain ventilated for at least 12 hours will be randomized to receive either propofol infusion (1 to 4 mg/kg/hr) or midazolam infusion (2 to 4 mcg/kg/min) for sedation. Level of sedation will be assessed using the Richmond Agitation Sedation Scale (RASS). Target RASS score for the day will be determined before starting the study drug and every morning at daily sedation holidays. RASS score will be assessed every 30 minutes till the target RASS is reached and then every 2 hourly or more frequently if needed. Infusion of the study drug will be continued till a maximum of three days or until sedation was no longer required, whichever occurs earlier. Sedation holidays will be given daily for 2 hours (8 am to 10 am) in all children, unless contraindicated. Fentanyl infusion at 2 to 4 mcg/kg/hr will be used for analgesia in both groups. All other treatment modalities including ventilation management and weaning, cardiovascular support and monitoring, etc will be similar in both groups, as per standard unit protocols. The primary outcome of the study is the percentage of time spent in the targeted sedation level in the first 72 hours after randomization. The secondary outcomes are need for top-up doses of midazolam, propofol, fentanyl, and vecuronium, 28 day ventilator free days, length of PICU and hospital stay, 28 day mortality, treatment failure rate, incidence of extubation failure, incidence of adverse events related to sedation, and incidence of occurrence of iatrogenic withdrawal syndrome and ICU delirium. Patients will be followed up till 28 days after randomization or death whichever is earlier. |