| CTRI Number |
CTRI/2024/07/070438 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparasion of Midazolam, Lorazepam and Haloperidol-Promethazine
combination for management of physically and verbally violent patients. |
|
Scientific Title of Study
|
Comparative study of Intramuscular Midazolam, Lorazepam and Haloperidol-Promethazine
combination for management of acute agitation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakhwinder Singh |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical
College and Hospital, Sector 32
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9478374749 |
| Fax |
|
| Email |
00lakhwinder00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priti Arun |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical
College and Hospital, Sector 32
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9646121612 |
| Fax |
0172-2609360 |
| Email |
drpritiarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakhwinder Singh |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D block, Government Medical
College and Hospital, Sector 32
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9478374749 |
| Fax |
|
| Email |
00lakhwinder00@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh,India Pincode- 160032 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Sector 32, Chandigarh |
| 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 Lakhwinder Singh |
Govenment Medical College and Hospital, Sector 32 |
Psychiatry OPD, Area 42, Level 4,
D block and EMO room, Level 1, A block
Chandigarh
CHANDIGARH |
9478374749
00lakhwinder00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, (2) ICD-10 Condition: F30-F39||Mood [affective] disorders, (3) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, (4) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Haloperidol plus Promethazine |
5mg haloperidol plus 50 mg promethazine ,Intramuscular injection, given once and repeated once, if required. |
| Comparator Agent |
Lorazepam |
2mg,Intramuscular injection, given once and repeated once, if required. |
| Intervention |
Midazolam |
5mg,Intramuscular injection, given once and repeated once, if required. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Altered Mental Status Scale (AMSS) score greater than 1 |
|
| ExclusionCriteria |
| Details |
Patient with known allergy of either midazolam or lorazepam or haloperidol or
promethazine.
Patient with medically reversible cause of agitation (hypotension, hypoxia or
hypoglycemia).
Patient known to be pregnant or lactating.
Patient presenting with drug withdrawals or drug intoxication within past 48 hours.
Patient with history of head injury within past 48 hours.
Patient in active Delirium.
Patient chemically restrained in past 24 hours. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time till adequate sedation using Altered Mental Status Scale (AMSS) |
0 min, then every 3 minutes till adequate sedation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Need for repeat sedation |
0,30 min, 1 hour, 6 hour, 12 hour |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| Date of Study Completion (India) |
10/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In the event that the patient meets the study’s eligibility requirements, socio-demographic and clinical profile and the baseline AMSS score will be gathered. CAM would be applied to filter out patients with delirium. Computer generated number will be used for randomization. Each patient would either receive 5mg midazolam or 2mg lorazepam or 5mg haloperidol and 50 mg promethazine combination. Time to adequate sedation (defined as AMSS score less than/equal to 0) will be recorded with a stopwatch. Occurrence of bradycardia (Pulse Rate <60 beats per minute), extrapyramidal adverse effects (akathisia or dystonia), allergic reactions (rash, wheezing, or anaphylaxis), hypoxemia (oxygen saturation <93%), or intubation will also be noted.Patient would be followed up till 12 hours after the intramuscular injection has been given. AMSS score would be calculated at 0, 30 min, 1 hour, 6 hour and 12 hour mark. Blood pressure, pulse rate, oxygen saturation and AIMS score (for extrapyramidal symptoms) would also be noted. In case the patient continues to have disruptive behavior at 30 minutes after first dose, repeat dose of same agent, that is, 5mg midazolam or 2mg lorazepam or 5mg haloperidol and 50 mg promethazine combination, will be considered and documented. If the patient remains disruptive at 1 hour mark or after 2 injections, it will be considered as “failure to sedateâ€, however management will continue as standard care. If repeat dose of sedative is given up till 12 hours after adequate sedation is once achieved, it will be documented. Comparison between 3 subgroups regarding time of adequate sedation and need for repeat sedation will be done. After the end of study period, that is 12 hours, treatment as usual will resume. |