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Completed

NCT Number: NCT05783128

The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.

The manipulations required during airway management and the different methods of establishing an airway (endotracheal intubation, supraglottic airway device etc) during anesthesia, as well as certain drugs used during anesthesia and sedation, may have an impact to the stomatognathic system. These effects can vary from a subtle temporomandibular joint disc displacement with reduction to the onset of temporomandibular disorders to previously healthy subjects.This observational prospective study aims at investigating the effect of different methods of airway management during anesthesia on the stomatognathic system (including temporomandibular joint, mastication muscles, occlusion etc).

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Key information

About this study

After being informed about the study, all patients giving written informed consent will undergo elective abdominal surgery or elective gynecological surgery (both open or laparoscopic surgeries), under general or regional anesthesia. Participants will be assigned to groups, depending on the method of airway management during anesthesia (endotracheal intubation, supraglottic airway device, sontaneous breathing).

Clinical examination of the stomatognathic system will be performed preoperatively and postoperatively (24 hours after surgery) and data concerning signs and symptoms associated with the development of temporomandibular disorders will be recorded. A follow-up questionnaire will be administered by telephone 30 days after surgery in order to record data concerning the stomatognathic system and mandibular function.

Parameters related to the physiology of the stomatognathic system, parameters related to the airway management technique, patient position, parameters related to postoperative recovery, as well as postoperative analgesic consumption will be studied.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women
  • 18-70 years old
  • ASA I-III
  • elective abdominal surgery or elective gynecological surgery
  • general or regional anesthesia

Exclusion criteria

  • edentulous patients
  • ear disease
  • history of head and/or neck cancer
  • head and neck surgery, surgery that is known to affect temporomandibular joints
  • nose and/or skull base fractures
  • history of dystonia/musculoskeletal disease that require treatment with muscle relaxant drugs
  • cognitive impairment
  • ASA > 3
  • patients which underwent over 3 attempts of airway establishment during airway management
  • change of anesthesia plan during surgery
  • patient refusal to participate
  • inability to comprehend Greek or English
  • patient participation in another research project during the previous 30 days

Treatment and study plan

Airway management techniques (exposure)

Other

The exposure reffers to the different methods of airway management during general or regional anesthesia.

Primary outcomes

  1. Pain free maximum mouth opening

    Time frame: 24 hours

    Assessment of maximum pain free inter-incisor distance (measured in millimeters). The examination will be conducted using the set of diagnostic tools for temporomandibular disorders (TMD), namely the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)

Secondary outcomes

  1. Range of movement of the temporomandibular joint

    Time frame: 24 hours

    Assessement of forward and lateral movements of the jaw using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)

  2. Temporomandibular joint disc displacement (with/without reduction)

    Time frame: 24 hours

    Assessement of clicking of the jaw while opening/closing the mouth using DC/TMD

  3. Articular sounds incidence

    Time frame: 24 hours

    Assessement of grinding noises and nonclassifiable sounds using DC/TMD

  4. Subjective limitation of jaw movement

    Time frame: 24 hours

    Assessement of subjective report of jaw movement limitation using DC/TMD

  5. Subjective report of orofacial pain

    Time frame: 24 hours

    Assessement of subjective report of orofacial pain using DC/TMD

Sponsors and collaborators

Lead sponsor

Aretaieio Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Mar 24, 2023
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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