The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Airway Management
- Sponsor
- Aretaieio Hospital
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Pain free maximum mouth opening
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Christina Orfanou
Resident anesthesiologist, MD, MSc
Aretaieio Hospital
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
- •patients which underwent over 3 attempts of airway establishment during airway management
- •change of anesthesia plan during surgery
- •patient refusal to participate
Outcomes
Primary Outcomes
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
- Temporomandibular joint disc displacement (with/without reduction)(24 hours)
- Range of movement of the temporomandibular joint(24 hours)
- Subjective limitation of jaw movement(24 hours)
- Articular sounds incidence(24 hours)
- Subjective report of orofacial pain(24 hours)