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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02618525
Date of registration:	23/11/2015
Prospective Registration:	Yes
Primary sponsor:	B.P. Koirala Institute of Health Sciences
Public title:	Supraorbital Pressure Versus Jaw Thrust for Assessing the Adequate Depth of Anesthesia for LMA Insertion in Children
Scientific title:	Comparison of the Supraorbital Pressure and Jaw Thrust as Indicators for Depth of Anesthesia for Laryngeal Mask Airway Insertion in Children
Date of first enrolment:	February 2016
Target sample size:	50
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02618525
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant).
Phase:	N/A

Countries of recruitment
Nepal

Contacts

Name:	Krishna Pokharel, MD
Address:
Telephone:
Email:
Affiliation:	B.P. Koirala Institute of Health Sciences

Name:	Asish Subedi, MD
Address:
Telephone:
Email:
Affiliation:	B.P. Koirala Institute of Health Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- ASA physical status 1 and 2

Exclusion Criteria:

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

Age minimum: 2 Years
Age maximum: 10 Years
Gender: All

Health Condition(s) or Problem(s) studied

Laryngeal Masks

Intervention(s)

Other: Supraorbital pressure

Other: Jaw thrust maneuver

Primary Outcome(s)

Number of successful LMA insertion at first attempt [Time Frame: Upto 1 minute after LMA insertion]

Secondary Outcome(s)

Non invasive blood pressure [Time Frame: Upto 5 minute after LMA insertion]

Incidence of swallowing [Time Frame: Upto 1 minute after LMA insertion]

LMA insertion score [Time Frame: Upto 1 minute after LMA insertion]

Ease of insertion of LMA [Time Frame: Upto 1 minute after LMA insertion]

Heart rate [Time Frame: Upto 5 minute after LMA insertion]

Incidence of coughing [Time Frame: Upto 1 minute after LMA insertion]

Incidence of laryngospasm [Time Frame: Upto 1 minute after LMA insertion]

Additional bolus dose of propofol if required [Time Frame: Upto 1 minute after LMA insertion]

Adequacy of mouth opening [Time Frame: Upto 1 minute after LMA insertion]

Incidence of movement [Time Frame: Upto 1 minute after LMA insertion]

Secondary ID(s)

Acd/10/071/072

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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