| CTRI Number |
CTRI/2013/11/004165 [Registered on: 22/11/2013] Trial Registered Retrospectively |
| Last Modified On: |
15/10/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trail to study the effects of drug dexmedetomidine in cleft palate surgeries |
|
Scientific Title of Study
|
A randomized controlled double blind trial to study the effects of dexmedetomidine in cleft palate surgeries |
| Trial Acronym |
DEXCP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Surana |
| Designation |
POST GRADUATE RESIDENT(2ND YEAR) |
| Affiliation |
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA
COLLEGE BUILDING, 4TH FLOOR
LTMMC & LTMGH,SION WEST MUMBAI
DEPARTMENT OF ANAESTHESIA
COLLEGE BUILDING,4TH FLOOR
LTMMC & LTMGH,SION WEST MUMBAI
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9769840898 |
| Fax |
02224063258 |
| Email |
drpriyankasurana@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DEVANGI PARIKH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA
COLLEGE BUILDING,4TH FLOOR
LTMMC & LTMGH,SION WEST MUMBAI
DEPARTMENT OF ANAESTHESIA
COLLEGE BUILDING,4TH FLOOR
LTMMC & LTMGH,SION WEST MUMBAI
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9820471638 |
| Fax |
02224063258 |
| Email |
sdevangi10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DEVANGI PARIKH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA
COLLEGE BUILDING,4TH FLOOR
LTMMC & LTMGH,SION WEST MUMBAI
DEPARTMENT OF ANAESTHESIA
COLLEGE BUILDING,4TH FLOOR
LTMMC & LTMGH,SION WEST MUMBAI
MAHARASHTRA
400022
India |
| Phone |
9820471638 |
| Fax |
02224063258 |
| Email |
sdevangi10@gmail.com |
|
|
Source of Monetary or Material Support
|
| LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
|
|
Primary Sponsor
|
| Name |
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIA
COLLEGE BUILDING ,4TH FLOOR
LTMMC & LTMGH,SION WEST MUMBAI |
| 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 PRIYANKA SURANA |
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL PLASTIC OT |
PLASTIC OT
3RD FLOOR HOSPITAL BUILDING
LTMMC AND LTMGH SION WEST MUMBAI
Mumbai
MAHARASHTRA |
9619660996
02224063258
drpriyankasurana@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| STAFF AND RESEARCH SOCIETY LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE MUHS NASHIK |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
PATIENTS HAVING CLEFT PALATE WHO ARE FIT FOR SURGERY, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
1 microgram per kg body weight to be given over 10 minutes IV as loading dose after induction followed by infusion at the rate of 0.5 microgram per kg body weight per hour diluted in 20ml Normal Saline dicontinued just before the last stich. |
| Comparator Agent |
MIDAZOLAM |
0.05 milligram per kg body weight to be given over 10 minutes IV after induction as loading dose followed by infusion of 20ml normal saline discontinued before the last stich. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA I
AGE 6 MONTHS TO 12 YEARS
EITHER SEX |
|
| ExclusionCriteria |
| Details |
ASA II
UNWILLING FOR CONSENT
HISTORY SUGGESTIVE OF KIDNEY LIVE CARDIAC DYSFUNCTION
ALLERGY TO ALPHA 2 ADRENERGIC AGONIST OR SULPHA DRUGS
BRADYCARDIA HR < 60/MIN |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
HAEMODYNAMIC STABILITY
ANALGESIC REQUIREMENT
RECOVERY PROFILE
SURGEON SATISFACTION SCORE |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
EMERGENCE AGITATION
POST OP SEDATION ANS ANALGESIC REQUIREMENT |
2 YEARS |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/11/2012 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS STUDY IS A RANDOMIZED DOUBLE BLIND PARALLEL GROUP CONTROLLED TRAIL TO STUDY THE EFFECTS OF DEXMEDETOMIDINE IN CLEFT PALATE SURGERIES CONDUTED IN LTMGH PLASTIC OT IN 60 PATIENTS IN 2 YEARS.THE PRIMARY OUTCOMES WILL BE HAEMODYNAMIC STABILITY ANALGESIC REQUIREMENT,RECOVERY PROFILE,SURGEONS SATISFACTION SCORE. |