Supraorbital Pressure Versus Jaw Thrust for Assessing the Adequate Depth of Anesthesia for LMA Insertion in Children

NCT02618525 | Completed

• 1 other identifier: Acd/10/071/072
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND AND OBJECTIVES The purpose of this study is to assess whether the loss of motor response to supraorbital pressure can be an alternative to that of jaw thrust to predict optimal condition for laryngeal mask airway (LMA) insertion in children. METHODOLOGY Fifty children (ASA I-II), aged 2 to 10 years, scheduled to receive general anesthesia that required LMA insertion were randomized to receive either supraorbital pressure (SOP) (n = 25) or jaw thrust (JT) (n = 25), after the loss of verbal response and body movements with a standard anesthetic. When motor response to the study intervention was absent, the LMA was inserted.

Conditions

Laryngeal Masks

Outcome Measures

Primary Outcomes (1)

• Number of successful LMA insertion at first attempt

  Upto 1 minute after LMA insertion

Secondary Outcomes (10)

• Ease of insertion of LMA

  Upto 1 minute after LMA insertion

• Adequacy of mouth opening

  Upto 1 minute after LMA insertion

• Incidence of swallowing

  Upto 1 minute after LMA insertion

• Incidence of coughing

  Upto 1 minute after LMA insertion

• Incidence of laryngospasm

  Upto 1 minute after LMA insertion

Study Arms (2)

Supraorbital pressure

ACTIVE COMPARATOR

Supraorbital pressure is applied by applying pressure over the notch on the inner aspect of eyebrow.

Other: Jaw thrust maneuver

Jaw thrust maneuver

ACTIVE COMPARATOR

Jaw thrust maneuver is performed by placing the index and middle fingers to physically pull the posterior aspects of the mandible upwards while their thumbs push down on the chin to open the mouth.

Other: Supraorbital pressure

Interventions

Supraorbital pressure OTHER

Supraorbital pressure is applied by applying pressure over the notch on the inner aspect of eyebrow.

Jaw thrust maneuver

Jaw thrust maneuver OTHER

Jaw thrust is performed by placing the index and middle fingers to physically pull the posterior aspects of the mandible upwards while their thumbs push down on the chin to open the mouth.

Supraorbital pressure

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status 1 and 2

You may not qualify if:

• Congenital, acute or chronic heart and lung disease, Skull fracture or orbital fracture

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

B. P. Koirala Institute Of Health Sciences

Dharān, Nepal

Location

Study Officials

• Krishna Pokharel, MD

  B.P. Koirala Institute of Health Sciences

  STUDY DIRECTOR

• Asish Subedi, MD

  B.P. Koirala Institute of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: February 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

NE (1)