Clinical trial NCT05485246: Advanced Multimodal Anesthesia Care for Patients Undergoing Oro-maxillofacial Surgery
Official title: Advanced Multimodal Anesthesia Care for Patients Undergoing Oro-maxillofacial Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthognathic Surgery
Keywords: orthognathic surgery
anesthesia
prospective analysis
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients without obviously systemic diseases who presentation of abnormal oro-maxillofacial anatomy needs to be corrected.

Brief summary: The purpose of this research is to develop from enhanced multimodal anesthesia care to verify and optimize ERAS strategies for orthognathic surgery. If the elements of anesthesia care can be accurately controlled, the harmful pressure factors caused by surgery can be minimized and the patients undergoing facial surgery can be improved.

Detailed description: Orthognathic surgery (Orthognathic surgery) is currently one of the most commonly performed surgical items in oral and maxillofacial surgery because it corrects facial deformities, improves teeth chewing and face glowing. In general, the kind of operations are performed under nasotracheal intubating general anesthesia.

Due to the patients were required for motionless, low pressure, controlled ventilation, and adequate analgesia during anesthesia undergoing orthognathic surgery, advanced multimodal anesthesia care developing to the Enhanced Recovery After surgery (ERAS) should be conducted under patient safety. The ERAS concept emphasizes the importance of clinical multidisciplinary teamwork cooperation including of oro-surgeon, anesthesiologist, operating and post-anesthesia care nurses. The core elements of ERAS lies in the management of the entire peri-operative period of anesthesia. In clinical practice, focus on entire anesthesia care during the operation includes of precise anesthesia depth, adequate muscle relaxation, multiple modes of pain controlled and adequate analgesia, stable body temperature maintenance, use of goal-oriented infusion therapy, early extubation, and prevention of postoperative nausea and vomiting.

Eligibility criteria: Inclusion Criteria:

* America society anesthesiologist classification class I to III patients undergoing oro-maxillo-facial surgery
* unlimited mouth opening
* nasotracheal intubation general anesthesia for at least 120 minutes.

Exclusion criteria:

* patients with arthritis with limited mouth opening
* diabetes with insulin treatment
* essential hypertension without controlled
* past history of malignant hyperthermia or personal or family history
* persistent liver dysfunction
* chronic renal insufficiency
* body mass index ≧35 kg/m2.

Primary outcomes:
measure: permitted hypotension during surgery with adequate depth of anesthesia and cardiac output
timeFrame: intraoperative 2-6 hours
measure: consumption of inhaled and intravenous anesthetics
timeFrame: intraoperative 2-6 hours
Secondary outcomes:
measure: time to successfully extubate the nasotracheal tube after anesthesia
timeFrame: from the end of surgery to the post-anesthesia care, assessed up to one hour
measure: safely discharged from post-anesthesia care unit (postoperative recovery room)
timeFrame: 2 hours
measure: side effects and adverse events
timeFrame: intraoperative and postoperative stages, assessed up to 48 hours
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
state: Sanmin Dist
Study officials:
affiliation: Kaohsiung Medical University Chung-Ho Memorial Hospital
name: Kuang-I Cheng, Phd
role: PRINCIPAL_INVESTIGATOR
References: