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

01 Nov 2017

The date of last modification

Jan 28, 2019



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 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


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/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

  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)

  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



State of Ethics Review Approval


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 & 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





Trial Completion details


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