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Effect Of Supraglottic Airway Devices On The Tempromandibular Joint Function Following Prolonged General Anesthesia

Effect Of Supraglottic Airway Devices On The Tempromandibular Joint Function Following Prolonged General Anesthesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05204914
Enrollment
60
Registered
2022-01-24
Start date
2022-01-30
Completion date
2022-12-30
Last updated
2022-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Change of Tempromandibular Joint Function With Supra Glottic Airway Devices

Keywords

The interincisors distance& movements of the jaw

Brief summary

Effect Of Supraglottic Airway Devices On The Tempromandibular Joint function Following Prolonged General Anesthesia

Detailed description

Supraglottic airway devices (SADs) are used for securing the airway in over 50% of general anesthetics; They are used for both spontaneously & ventilated patients; They also used as conduits to aid endotracheal intubation when both positive mechanical ventilation ( PMV) & tradional endotracheal intubation( ETT) have failed All (SADs) consist of a tube that connected to a breathing circuit or a breathing bag which is attached to a hypopharengeal device that seals air flow to the glottis There are many types of SADs including I-Gel, intubating laryngeal mask airway (LMA), LMA CTrash and LMA proseal Although considered relatively safe devices; and have many advantages as they are less invasive than EET, less incidence of bronchospasm, don't often require muscle relaxation or neck mobility There are several potential complications & disadvantages ; Include temporomandibular joint (TMJ) dysfunction, increases the risk of aspiration, more gas leak &pollution, less safe in prone postion & deeper anaethesia is required This study will investigate (TMJ) dysfunction following the use of a (SAD) during general anesthesia, as There are a number of insertion maneuvers described for (SADs) \[2\] such as a jaw thrust may result in temporomandibular joint (TMJ) dysfunction by anteriorly displacing the mandible . In addition, other factors such as degree of muscle relaxation leading to hypotonicity of jaw muscles and passive mouth opening. In addition, for the duration of the operation the mouth is kept slightly open by a breathing tube may result in (TMJ) dislocation. The inter-incisor distance will be measured using a Therabite â ruler (ATOS Medical, Nottingham, UK). This has a scale from 0 to 70 mm with 1-mm markings. The accuracy of this type of ruler is1.0 mm. The Therabite ruler was chosen as it routinely used by the investigators for (TMJ) assessment in the maxillofacial clinic.

Interventions

DEVICESupra glottic airway devices

Using the device in save air way in patients under general anesthesia and the change in the tempromandibular joint will be evaluated

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion The study will include 60 adult patients (\>18 years old) with ASA physical status class I and class II scheduled for elective surgery under general anesthesia where SADs ara planned to be used as airway devices

Exclusion criteria

1. Patient refusal 2. limited mouth opening(\<2 fingers) 3. Facial &upper airway trauma 4. Patients with dentures or who were edentulous (as accurate objective measurements would be difficult to determine) 5. Head and neck surgery (as surgery may influence TMJ function) 6. GITsurgery (as SAD doesn't completely protect air way against aspiration ) 7. Pt with preexisting tempromadibular joint dysfunction 8. Duration of anaethesia less than 1 h or more than 4hs-

Design outcomes

Primary

MeasureTime frameDescription
Change in tempromandibular jiont functionSingle measurement Within 24 hours postoperativeThe change in inter incisors distance,forword movement&lat movement of the jow post operative will be measured also any post op pain or difficulty in movement of the jow will be recorded

Secondary

MeasureTime frameDescription
Other complications of supraglottic airway devicesIntra operative &24hours postoperativeIncluding aspiration and airway edema

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026