| CTRI Number |
CTRI/2024/06/068582 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of sedation efficacy of the two sedative agents: Dexmedetomidine and Midazolam in critically ill children |
|
Scientific Title of Study
|
Comparison of sedation efficacy of dexmedetomidine and midazolam in critically ill children - A single-blinded, parallel design, Randomized 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 |
Varun M Angadi |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Raipur |
| Address |
Room No - 2C3, 2nd floor, Pediatric Critical Care division - PICU, Department of Pediatrics, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9538636135 |
| Fax |
|
| Email |
Angadi.varun@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Jindal |
| Designation |
Additional Professor, Department of pediatrics |
| Affiliation |
AIIMS Raipur |
| Address |
Room No: 1111, 1st floor, AIIMS college building (administrative block), AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8224014667 |
| Fax |
|
| Email |
dratuljindal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varun M Angadi |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Raipur |
| Address |
Room No - 2C3, 2nd floor, Pediatric Critical Care division - PICU, Department of Pediatrics, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9538636135 |
| Fax |
|
| Email |
Angadi.varun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drugs used in the study are a part of hospital patient supplies and shall indented as needed
All India Institute of Medical Sciences, Great Eastern road, Tatibandh, Raipur,
Chhattisgarh - 492099
India |
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
AIIMS, Tatibandh, Raipur - 492099, Chhattisgarh, India |
| 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 Varun M Angadi |
AIIMS Raipur |
Room No- 2C3, 2nd floor, Pediatric Intensive Care Unit, Department of Pediatrics
Raipur
CHHATTISGARH |
9538636135
angadi.varun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G35-G37||Demyelinating diseases of the central nervous system, (2) ICD-10 Condition: G00-G09||Inflammatory diseases of the central nervous system, (3) ICD-10 Condition: G20-G26||Extrapyramidal and movement disorders, (4) ICD-10 Condition: J00-J06||Acute upper respiratory infections, (5) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue, (6) ICD-10 Condition: K50-K52||Noninfective enteritis and colitis, (7) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, (8) ICD-10 Condition: E08-E13||Diabetes mellitus, (9) ICD-10 Condition: D55-D59||Hemolytic anemias, (10) ICD-10 Condition: T36-T50||Poisoning by, adverse effect of and underdosing of drugs, medicaments and biological substances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Route of administration: intravenous infusion
Dose: starting @ 0.25mcg/kg/hr till maximum dose of 0.75mcg/kg/hr
Duration: 5 days after enrolment or till extubation, whichever is earlier |
| Comparator Agent |
Midazolam |
Route of administration: intravenous infusion
Dose: starting @ 2mcg/kg/min till maximum dose of 4 mcg/kg/min
Duration: 5 days of enrolment or till extubation, whichever is earlier |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 month to 15 years admitted in PICU, on invasive mechanical ventilation with an
endotracheal tube, expected to be requiring sedation and ventilation for more than 24 hours and
having a RASS score of ≥ 1 at PICU admission |
|
| ExclusionCriteria |
| Details |
1) Primary central nervous system disease
2) Hepatic impairment
3) Patients on neuromuscular blocker agent intravenous infusions
4) Post cardiac surgery patients in the first 48 hours of surgery with high risk of low cardiac
output state
5) Patients diagnosed with atrio-ventricular conduction blocks or past history of the same
6) Previous participation in the study
7) Consent denial |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportion of 2 hourly sedation data points in target range [ BIS target → 40 to 70 / RASS
target → 0 to -4] |
5 days from enrolment or till extubation whichever is earlier |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of intermittent sedo-analgesic or neuromuscular agent bolus doses administered to maintain optimum sedation level |
5 days of enrolment or till extubation, whichever occurs earlier |
| Incidence of Iatrogenic withdrawal syndrome |
28 days of enrolment |
| Incidence of bradycardia and hypotension while on sedative infusion |
5 days of enrolment or till extubation, whichever occurs earlier |
| Duration of mechanical ventilation |
till extubation |
| Length of ICU stay |
discharge from ICU |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
17/06/2024 |
| 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 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 - NO
|
|
Brief Summary
|
Sedation in ICU using benzodiazepine agents is associated with increased delirium, withdrawal, length of stay translating into increased morbidity and mortality. Dexmedetomidine, on the other hand has shown to be atleast as efficacious as benzodiazepines while reducing the above-mentioned adverse effects. We propose to compare the sedation efficacies of the two drugs in terms of maintaining target sedation levels while also ensuring better patient morbidity outcomes. The study shall be a randomized, controlled, parallel group trial using midazolam and dexmedetomidine as sedative infusions for 5 days or till extubation whichever occurs is earlier. Level of sedation shall be monitored using Richmond agitation sedation scale (RASS) and Bi-Spectral Index monitor. All patients shall be under continuous cardio-respiratory monitoring. Basic demographic details, admission physiological scores - PRISM -3, pSOFA, vital parameters, basic investigations, dose of the sedative agents used, number of bolus doses required to maintain optimum sedation, length of ICU stay and ventilation duration shall be recorded. Withdrawal symptoms shall be monitored till day 28 of enrolment using Withdrawal Assessment Tool-1. Appropriate statistics shall be applied to analyze the collected data. |