| CTRI Number |
CTRI/2017/09/009943 [Registered on: 28/09/2017] Trial Registered Prospectively |
| Last Modified On: |
24/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [premedication] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
to compare oral midazolam with dexmedetomidine for sedation
given before surgery. |
|
Scientific Title of Study
|
Comparison of oral midazolam with two different doses of oral dexmedotimidine for premedication in pediatric patients-A Randomised control double blind study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DUSU LALIN |
| Designation |
MD trainee |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,I.G.I.M.S,PATNA.
Patna
BIHAR
800014
India |
| Phone |
7367967439 |
| Fax |
|
| Email |
dusununlalin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SWATI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Indira Gandhi institute of medical sciences |
| Address |
Department of anaesthesiology,I.G.I.M.S,PATNA.
Patna
BIHAR
800014
India |
| Phone |
8544413241 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DUSU LALIN |
| Designation |
MD trainee |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,I.G.I.M.S,PATNA.
Patna
BIHAR
800014
India |
| Phone |
7367967439 |
| Fax |
|
| Email |
dusununlalin@gmail.com |
|
|
Source of Monetary or Material Support
|
| INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, Sheikhpura, Patna, Bihar 800014 |
|
|
Primary Sponsor
|
| Name |
Dusu Lalin |
| Address |
Department of Anaesthesiology,IGIMS,PATNA. |
| 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 |
| Dusu Lalin |
Indira Gandhi Institute of Medical Sciences,Shiekhpura, Patna, Bihar |
Anaesthesia department , Operation theatre complex.
Patna
BIHAR |
7367967439
dusununlalin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira Gandhi Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pateints posted for pediatric surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Midazolam and Dexmedetomidine in two doses |
Oral Dexmedetomidine and Midazolam given for premedication prior to surgery. |
| Intervention |
Oral Midazolam and Dexmedetomidine given. |
Oral 0.5mg/kg BW Midazolam and Dexmedetomidine 2mcg/kg bw and 4mcg/kg bw give orally for premedication 60 minutes prior to surgery. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2.
Age 1-7 years.
Any surgery under general anesthesia. |
|
| ExclusionCriteria |
| Details |
Haemodynamically unstable
Mental retardation or neurobehavioral disorders.
Treatment with sedatives or anticonvulsants. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sedation score after Premedication. |
60 minutes after Premedication |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parents seperation anxiety, Mask acceptance on Induction , Anxiety in PACU |
1 hour, At induction and In PACU. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
04/10/2017 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
TRIAL is not completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare oral dexmedetomidine to oral midazolam for premedication in paediatric patients. To find most optimum dose of dexmedetomidine for oral premedication. 300 patients to be enrolled for study in age group 1 yrs to 7 yrs. |