The Effect of Different Methods of Airway Management on the Stomatognathic System: an Observational Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Pain free maximum mouth opening
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •18-70 years old
- •ASA I-III
- •elective abdominal surgery or elective gynecological surgery
- •general or regional anesthesia
排除标准
- •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
- •inability to comprehend Greek or English
- •patient participation in another research project during the previous 30 days
结局指标
主要结局
Pain free maximum mouth opening
时间窗: 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)
次要结局
- 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)
研究者
Christina Orfanou
Resident anesthesiologist, MD, MSc
Aretaieio Hospital