| CTRI Number |
CTRI/2024/03/064208 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare midazolam and propofol for prevention of emergence agitation in children |
|
Scientific Title of Study
|
Comparison of midazolam with propofol given at the end of surgery for prevention of emergence delirium in children undergoing infraumbilical abdominal surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Safiqur Rahman |
| Designation |
PG ANAESTHESIA |
| Affiliation |
ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL,NEW DELHI |
| Address |
Room No.301,Department of Anaesthesia, PGI Building,ABVIMS & DR RML Hospital,New Delhi, 110001
Central
DELHI
110001
India |
| Phone |
7002423646 |
| Fax |
|
| Email |
Safiqurrahman57@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nang Sujali Choupoo |
| Designation |
Associate Professor |
| Affiliation |
ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL ,NEW DELHI |
| Address |
ROOM NO.301 3RD Floor, Department of Anaesthesia, PGI Building, ABVIMS & DR RML Hospital
Central
DELHI
110001
India |
| Phone |
8587887234 |
| Fax |
|
| Email |
sujalichoupoo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Nang Sujali Choupoo |
| Designation |
Associate Professor |
| Affiliation |
ABVIMS & DR RAM MANOHAR LOHIA HOSPITAL ,NEW DELHI |
| Address |
Room No.301 3rd Floor, Department Of Anaesthesia, PGI Building, ABVIMS & DR RML Hospital
Central
DELHI
110001
India |
| Phone |
8587887234 |
| Fax |
|
| Email |
sujalichoupoo@yahoo.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS & DR RML Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
ABVIMS DR RML HOSPITAL |
| Address |
Baba Kharak Singh Marg,Near connaught place, New Delhi,110001 |
| Type of Sponsor |
Government medical college |
|
|
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 SAFIQUR RAHMAN |
ABVIMS & DR RML HOSPITAL |
Room No.301, PGI building 3rd floor, Department of Anaesthesiology, ABVIMS & DR RML Hospital,Baba Kharak Singh Marg, Connaught Place, New Delhi,110001
Central
DELHI |
7002423646
Safiqurrahman57@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr RML Hospital,New Delhi Ethics Committee at New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Midazolam or Propofol |
At the end of surgery, single dose of intravenous midazolam(0.03mg/kg body weight) or intravenous propofol(1mg/kg body weight) will be given to the patients to compare their effect on prevention of emergence delirium in children |
| Intervention |
Inj Midazolam or Inj propofol |
At the end of surgery, single dose of intravenous midazolam(0.03mg/kg) or intravenous propofol(1mg/kg) will be given to the patients. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA class 1&2 |
|
| ExclusionCriteria |
| Details |
Children with developmental delay, psychological and neurological disorders, abnormal airway, respiratory disease and cardiovascular diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of emergence delirium using Paediatric Anaesthesia Emergence Delirium(PAED) scale |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recovery time, Duration of sevoflurane administration, FLACCS Score in both groups, any adverse effects like nausea/vomiting,laryngospasm,desaturation,bronchospasm |
FLACCS score measured at baseline |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/03/2024 |
| 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="5"
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
|
Emergence delirium is an acute state of confusion during recovery from anaesthesia. Incidence of emergence delirium in children ranges from 10 to 80% . Emergence delirium may have clinically significant consequences such as to patients or medical staffs, fallinf out of bed, bleeding at the surgical site, accidental removal of drain or intravenous catheters, unintented extubation , respiratory depression and increasing medical care cost. There is literature suggesting that some medication may prevent emergence delirium in children.Thus we plan to study the prevention of emergence delirium in children undergoing infraumbilical abdominal surgery by administering midazolam or propofol at the end of surgery. |