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 -

SLCTR Registration Number

SLCTR/2017/038


Date of Registration

01 Nov 2017

The date of last modification

Nov 01, 2017



Application Summary


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 of Health Condition(s) Studied

Hemodynamic response during airway insertion


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111 -1204 - 4590


Any other number(s) assigned to the trial and issuing authority

None


Trial Details


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


Assignment

Parallel


Purpose

Basic science


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

  1. Male and female adults (>18 years)
  2. American society of Anaesthesiologists physical status classes I and II,
  3. Normal airway
  4. Undergoing elective surgeries of short duration (1 hour or less)

Exclusion criteria

  1. Full stomach
  2. Emergency surgery
  3. Significant cardiorespiratory illness
  4. Bowel surgeries
  5. Laparoscopic surgeries
  6. Difficult airway
  7. Known allergy to study drugs


Primary outcome(s)

Change in the following haemodynamic parameters 1. Pulse rate per minute 2. Blood pressure as measured as measured by non invasive automated monitor. (BPL EXCELO)


Primary outcome(s) - Time of assessment(s)

Immediately before and after LMA insertion


Secondary outcome

  1. Upper airway trauma by visual inspection of the device and the oropharynx
  2. Desaturation (SpO2 <90%), as determined by a AS/3 Compact Anesthesia Monitor
  3. Patient movement on a 2 point scale (present/absent)
  4. Ease of insertion on a 5 point Likert scale (1=very easy and 5=very difficult)
  5. Gagging: On clinical observation
  6. Laryngospasm: On clinical observation
  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)

Secondary outcome(s) - Time of assessment(s)

  1. Upper airway trauma by visual inspection of the device and the oropharynx
  2. Desaturation (SpO2 <90%), as determined by a AS/3 Compact Anesthesia Monitor
  3. Patient movement on a 2 point scale (present/absent)
  4. Ease of insertion on a 5 point Likert scale (1=very easy and 5=very difficult)
  5. Gagging: On clinical observation
  6. Laryngospasm: On clinical observation
  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)


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


Recruitment status

Pending


State of ethics review approval

Approved by Institutional Ethical Committee, Vinayaka Mission’s Medical college, Karaikal, Puducherry, India on 4th May 2016 (valid 3years)


Funding source

None (investigator funded)



Contact & Sponsor Information


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/

Secondary study sponsor (If any)

None