Home » Trials » SLCTR/2017/038
Effect of etomidate compared to propofol on haemodynamic parameters during ProSeal laryngeal mask airway (LMA) insertion - A randomised controlled trial
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SLCTR Registration Number
SLCTR/2017/038
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effect of etomidate compared to propofol on haemodynamic parameters during ProSeal laryngeal mask airway (LMA) insertion - A randomised controlled trial
Public Title of Trial
Propofol vs etomidate on haemodynamic parameters during ProsSeal laryngeal mask insertion
Disease or Health Condition(s) Studied
Hemodynamic response during airway insertion
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111 -1204 - 4590
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
What are effects of etomidate when compared to propofol on pulse rate and blood pressure when used as induction agents during ProSeal laryngeal mask airway (LMA) insertion?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Basic science
Study Phase
Not Applicable
Intervention(s) planned
Study will take place a teaching hospital in the coastal region of Puducherry state, India. Randomization will be by computer generated randomization sequence in blocks of 5.
The intervention arm will receive a single dose of etomidate 0.3 mg/kg intravenously at the time of LMA insertion.
The control arm will receive propofol 2mg/kg intravenously at the time of LMA insertion.
All other management will be provided to participants in both arms according to standard anaesthetic protocols. Participants, health care providers and data collectors will be blinded to the intervention status.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Change in the following haemodynamic parameters 1.1. Pulse rate per minute 1.2. Blood pressure as measured as measured by non invasive automated monitor. (BPL EXCELO) |
[ Immediately before and after LMA insertion ] |
Secondary outcome(s)
|
1.
Upper airway trauma by visual inspection of the device and the oropharynx |
[ During LMA insertion and LMA removal ] |
|
2.
Desaturation (SpO2 <90%), as determined by a AS/3 Compact Anesthesia Monitor |
[ During LMA insertion. ] |
|
3.
Patient movement on a 2 point scale (present/absent) |
[ During LMA insertion. ] |
|
4.
Ease of insertion on a 5 point Likert scale (1=very easy and 5=very difficult) |
[ During LMA insertion. ] |
|
5.
Gagging: On clinical observation |
[ During LMA insertion. ] |
|
6.
Laryngospasm: On clinical observation |
[ During LMA insertion. ] |
|
7.
Post-operative sore throat: on a 10 point visual analogue scale / verbal rating numerical pain score (0=no pain and 10 worst pain imaginable) |
[ During LMA removal. ] |
Target number/sample size
80 (40 in each arm)
Countries of recruitment
India
Anticipated start date
2017-11-20
Anticipated end date
2018-02-20
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-05-04
Approval number
Not available
Details of Ethics Review Committee
| Name: | Ethical Committee, Vinayaka Mission’s Medical College |
| Institutional Address: | Karaikal, Puducherry, India |
| Telephone: | Not Available |
| Email: | Not Available |
Contact person for Scientific Queries/Principal Investigator
Prasanna Vadhanan
Professor
Department of Anaesthesiology
Vinayaka Missions Medical College
Karaikal, Puducherry 609609, India
Tel: +919486489690
vadhanan.prasanna@gmail.com
Contact Person for Public Queries
Krishna Chaitanya
Post graduate resident
Department of Anaesthesiology
Vinayaka Missions Medical College
Karaikal, Puducherry 609609, India
Tel: +917674829565
Krishna.c.25@gmail.com
Primary study sponsor/organization
Vinayaka Missions Medical College
Karaikal, Puducherry 609609, India
Tel: 04368 263340
Fax: 04368 263340
dean@vmmckkl.com
http://vmmckkl.com/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
