| CTRI Number |
CTRI/2016/12/007572 [Registered on: 14/12/2016] Trial Registered Retrospectively |
| Last Modified On: |
15/11/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of two group of drugs while giving anesthesia in patients posted for major surgeries. |
|
Scientific Title of Study
|
Comparison of hemodynamic effects and ease of I-gel insertion with dexmedetomidine propofol vs fentanyl propofol |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Dabas |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College , Post box no 53 , Light house hill road ,Mangalore
Katurba Medical College , Post box no 53 Light house hill road , Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9844619200 |
| Fax |
8202571982 |
| Email |
priyankadabas88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh M Rasquinha |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College , Post box no 53 , Light house hill road , Mangalore
Katurba Medical College ,Post box no 53 ,Light house hill road , Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9845107528 |
| Fax |
8202571982 |
| Email |
dr_jitesh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Dabas |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College Mangalore |
| Address |
Kasturba Medical College ,Post box no 53 ,Light house hill road , Mangalore
Kasturba Medical College ,Post box no 53 ,Light house hill road , Mangalore
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9844619200 |
| Fax |
8202571982 |
| Email |
priyankadabas88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College , Post box no 53 , Light house hill road, Mangalore |
|
|
Primary Sponsor
|
| Name |
Priyanka Dabas |
| Address |
Flat no 402 , Vishwas manor appartment , Falnir , Mangalore |
| Type of Sponsor |
Other [Self] |
|
|
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 Dabas |
Kasturba Medical College Hospital |
Dept of anesthesiology,5 th floor, KMC hospital, Attavar , Mangalore
Dakshina Kannada
KARNATAKA |
9844619200
8202571982
priyankadabas88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1 and ASA 2 patients posted for surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator B : Fentanyl |
Dose : 2 mcg per kg one dose
Route : Intravenous ,
used before induction |
| Comparator Agent |
Comparator A : Dexmedetomidine |
Dose : 2 mcg per kg one dose
Route : Intravenous over 10 min used before induction . |
| Intervention |
Intervention : Propfol
|
Dose : 2 mg per kg one dose
Route : Intravenous
used for induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I & II.
2. 18-60 years of age.
3. Weight 35-80kgs.
4. Who gives informed written consent.
5. Patients scheduled to undergo elective surgical procedures .
|
|
| ExclusionCriteria |
| Details |
1. Risk of gastric aspiration.
2. Patient who refuse for the study or have any known allergy.
3. Patients undergoing oral surgeries.
4. Those with Hepatic/ Renal/cardio-pulmonary abnormality, bleeding diathesis.
5. ASA grade III & IV patients.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Heart rate, Respiratory rate ,Non invasive blood pressure and Oxygen saturation will be recorded before induction |
Baseline, 30sec after induction, 1min, 3min,5min,10min and 15min after insertion of I-gel |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| jaw mobility and coughing / bucking |
2 optimum for i gel insertion |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/02/2015 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized clinical trial : hemodynamic effects and ease of I gel insertion in dexmedetomidine - propofol vs propofol- fentanyl group with sample size of 40 in each group . total 80 cases ( ASA 1 and ASA 2 posted for elective surgery) will be studied and their parameters will be assesed in terms of heart rate , o2 saturation , respiratory rate and blood pressure at different point of time before and after induction after giving respective drugs . ease of Igel insertion will be assesed as per their degree of jaw relaxation . Study hypothesis :Introduction Aim Objective Review of literature materials and methods : study design study setting study population sample size inclusion criteria exclusion criteria randomization methodology study duration data analysis references annexure 1 ( consent ) annexure 2 annexure 3 ( patient performa )
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