| CTRI Number |
CTRI/2021/01/030261 [Registered on: 05/01/2021] Trial Registered Prospectively |
| Last Modified On: |
03/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"A Comparative study of intravenous use of combination of Propofol with Dexmedetomidine and combination of Etomidate with Dexmedetomidine for induction of patient for Laryngeal Mask Airway insertion in short surgical procedures" |
|
Scientific Title of Study
|
"Comparision of Propofol with Dexmedetomidine and Etomidate with Dexmedetomidine for Laryngeal Mask Airway insertion in short surgical procedures" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shruti Bhushan Aparajita |
| Designation |
1st year PG Resident |
| Affiliation |
Krishna Institute Of Medical Sciences |
| Address |
Department of Anaesthesia, Krishna Institute of Medical Sciences, Karad
Maharashtra
Satara
MAHARASHTRA
415539
India |
| Phone |
8805227102 |
| Fax |
|
| Email |
drshrutibhushan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naseema v Kanase |
| Designation |
Associate Professor |
| Affiliation |
Krishna Institute of Medical Sciences |
| Address |
Department of Anaesthesia, maharashtra Krishna Institute of Medical Sciences, Karad
Satara
MAHARASHTRA
415539
India |
| Phone |
9822082226 |
| Fax |
|
| Email |
naseemakanase@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Bhushan Aparajita |
| Designation |
1st year PG Resident |
| Affiliation |
Krishna Institute of Medical Sciences |
| Address |
Department of Anaesthesia, maharashtra Krishna Institute of Medical Sciences, Karad
Satara
MAHARASHTRA
415539
India |
| Phone |
8805227102 |
| Fax |
|
| Email |
drshrutibhushan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna Institute Of Medical Sciences, Deemed To Be University,
NH4, Pune - Bangalore Highway, District Satara, Agashivnagar, Malkapur, Karad, Maharashtra - 415539 |
|
|
Primary Sponsor
|
| Name |
Krishna Institute Of Medical Sciences |
| Address |
Krishna Institute Of Medical Sciences, Deemed To Be University,
NH4, Pune - Bangalore Highway, District Satara, Agashivnagar, Malkapur, Karad, Maharashtra - 415539 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shruti Bhushan Aparajita |
Krishna Institute Of Medical Sciences |
Ward no.13, OT, Krishna Institute Of Medical Sciences, Deemed To Be University,
NH4, Pune - Bangalore Highway, District Satara, Agashivnagar, Malkapur, Karad, Maharashtra - 415539
Satara
MAHARASHTRA |
8805227102
drshrutibhushan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,Krishna Institute Of Medical Sciences, Deemed To Be University, Karad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Propofol With Dexmedetomidine And Etomidate With Dexmedetomidine |
Inj Dexmedetomidine 1mcg/kg over 10mins followed by Inj.Propofol 2.5mg/kg for LMA insertion V/S
Inj Dexmedetomidine 1mcg/kg over 10mins followed by Inj.Etomidate 0.3mg/kg for LMA insertion
|
| Intervention |
Propofol With Dexmedetomidine And Etomidate With Dexmedetomidine |
To study and compare the hemodynamic changes and the ease of LMA insertion with the number of attempts. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II. |
|
| ExclusionCriteria |
| Details |
1.Known allergies to the drugs used.
2.Known allergies to egg.
3.Patients belonging to ASA III and above.
4.Patients with considerable pathology in larynx or pharynx.
5.Patients with autonomic dysfunction.
6.Patients with anticipated difficult intubation.
7.Patients with history of bronchial asthma.
8.Patient refusal.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic stability and ease of LMA insertion |
1 Minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Pain on Injection due to Propofol and Etomidate. |
18 Months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/02/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There are many studies to evaluate the hemodynamic stability and ease of insertion in LMA insertion with ropofol and etomidate. But there is lack of evidence of effects of dexmedetomidine as a coinduction agent for LMA insertion with propofol and etomidate. Therefore, more detailed research is required to evaluate the effects of dexmedetomidine as a coinduction agent with propofoland etomidate. Both etomidate and propofol cause pain on injection and this is one of the most common adverse effect of these drugs. Dexmedetomidine administered prior to thses drugs will also result in decrease in pain on injection due to both the drugs. |