Clinical Trials Directory

Trials / Completed

CompletedNCT05783128

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

Status
Completed
Phase
Study type
Observational
Enrollment
134 (actual)
Sponsor
Aretaieio Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERAirway management techniques (exposure)The exposure reffers to the different methods of airway management during general or regional anesthesia.

Timeline

Start date
2023-03-01
Primary completion
2023-12-01
Completion
2024-07-31
First posted
2023-03-24
Last updated
2024-10-28

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT05783128. Inclusion in this directory is not an endorsement.