| CTRI Number |
CTRI/2013/09/004008 [Registered on: 23/09/2013] Trial Registered Prospectively |
| Last Modified On: |
21/09/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
USE OF DEXMEDETOMIDINE IN ANAESTHESIA PRACTICE FOR LAPROSCOPY. |
|
Scientific Title of Study
|
ROLE OF DEXMEDETOMIDINE AS AN ANAESTHETIC ADJUVENT FOR LAPROSCOPIC SURGERY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Science and Research Center. |
| Address |
PEOPLES COLLEGE OF MEDICAL SCIENCE AND RESEARCH CENTRE.
BHANPUR BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554005200 |
| Fax |
|
| Email |
vaishaliwaind@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Science and Research Center. |
| Address |
PCMS AND RC
BHANPUR BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554005200 |
| Fax |
|
| Email |
vaishaliwaind@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Waindeskar |
| Designation |
Associate Professor |
| Affiliation |
Peoples College of Medical Science and Research Center. |
| Address |
PCMS AND RC
BHANPUR BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
07554005200 |
| Fax |
|
| Email |
vaishaliwaind@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Peoples College Of Medical Science and Research Centre |
| Address |
PCMS AND RC
BHANPUR,BHOPAL
MADHYA PRADESH 462037 |
| Type of Sponsor |
Private 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 VAISHALI WAINDESKAR |
PEOPLES HOSPITAL |
DEPARTMENT OF ANAESTHESIA PEOPLES MEDICAL COLLEGE BHANPUR BHOPAL MADHYA PRADESH 462037 INDIA
Bhopal
MADHYA PRADESH |
09575604490
vaishaliwaind@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
AGE 18 TO 60 YRS
BOTH GENDER
ASA GRADE I AND II POSTED FOR LAPROSCOPIC SURGERY like laparoscopic appendisectomy, cholecystectomy, oophorectomy, addisiolysis, diagnostic laproscopy , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
Before induction 1mcg/kg for 20min,then changed to 0.2mcg/kg/min till extubation. |
| Comparator Agent |
Normal saline |
Before induction 1ml/kg for 20min then changed to 0.2ml/kg/mintill extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I& II patients.
Posted for Laproscopic surgery.
|
|
| ExclusionCriteria |
| Details |
ASA GRADE III AND IV PATIENT.
Hypertensive and ISCHAEMIC HEART DISEASE PATIENT.
PATIENTS WITH CARDIOVASCULAR AND RENAL DISEASE.
PREGNANT PATIENT.
|
|
|
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 |
| PULSE RATE, BLOOD PRESSURE, SATURATION ENDTIDALCO2 BEFORE AND AFTER GIVING LOADING DOSE OF DEXMEDITOMIDINE,RESPONCE TO INTUBATION AND PNEUMOPERITONIUM ,EXTUBATION.REQUIRMENT OF INHALATIONAL AGENT,MUSCLE RELAXANTAND OTHER DRUGS. |
TWO HRS AFTER THE COMPLETION OF SURGERY. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
01/10/2013 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Randomised Double Blind Case Controll Study ;Preparation of INFUSION OF DEXMED IN NS 100mcg/100ml i.e.1mcg/ml GROUP C ( N=30) - Receives NS Iml/kg before induction for 20min. Infusion changed to 0.2ml/kg/hr after 20 min till extubation. GROUP D (N=30 ) - Receives Dexmed 1ml/kg before induction for 20min. Infusion changed to 0.2ml/kg/hr after 20min till extubation. Induction with I.V. Propofol 5mg incremental doses till loss of eye lid reflex. Scoline 1.5mg/kg,oral intubation with appropriate size ETT tube. Heart rate,B.P.Saturation,ETCO2 responce-1) after 20 min infusion2)to intubation 3)to pneumoperitonium 4)intra op.monitoring 5)to extubation 6) 2hrs post op. will be recorded. Requirment of analesia will be noted. Any additional drugs required when rise in H.R. or B.P. like Beta blockers,Nitroglycerine will be noted. |