Clinical trial NCT05783128: The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.
Official title: The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Management
Endotracheal Intubation
Supraglottic Airway Device
Regional Anesthesia
Keywords: Intubation
Laryngeal Masks
Temporomandibular Joint Disorders
Orofacial Pain
Lead sponsor: Aretaieio Hospital
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18-70, of either sex (male, female), American Society of Anesthesiologists (ASA) physical status I-III and scheduled for elective abdominal surgery or elective gynecological surgery (both open or laparoscopic surgeries), under general or regional anesthesia, will be enrolled in the study. They will voluntarily participate in the study, have given their informed consent in writing. Participants will be assigned to groups, depending on the method of airway management during anesthesia.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain free maximum mouth opening
timeFrame: 24 hours
Secondary outcomes:
measure: Range of movement of the temporomandibular joint
timeFrame: 24 hours
measure: Temporomandibular joint disc displacement (with/without reduction)
timeFrame: 24 hours
measure: Articular sounds incidence
timeFrame: 24 hours
measure: Subjective limitation of jaw movement
timeFrame: 24 hours
measure: Subjective report of orofacial pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Aretaieio Hospital, National and Kapodistrian University of Athens
Study officials:
affiliation: Aretaieio Hospital, National and Kapodistrian University of Athens
name: Assosiate Professor Athanasia Tsaroucha
role: STUDY_DIRECTOR
References: