Advanced Multimodal Anesthesia Care for Patients Undergoing Oro-maxillofacial Surgery

Orthognathic Surgery Clinical Trial

Official title:

Advanced Multimodal Anesthesia Care for Patients Undergoing Oro-maxillofacial Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05485246
• Other study ID #: KMUHIRB-F(I)-20210211
• Status: Enrolling by invitation
• Start date: August 15, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Orthognathic Surgery

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung	Sanmin Dist

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	permitted hypotension during surgery with adequate depth of anesthesia and cardiac output	to decrease intra-operative bleeding as patient undergoing oromaxillofacial surgery, intentional hypotension is allowed. however, adequate depth of anesthesia, proper cardiac output, respiratory parameters, temperatures should be monitored	intraoperative 2-6 hours
Primary	consumption of inhaled and intravenous anesthetics	to maintain adequate depth of anesthesia during intentional hypotension, consumptions of inhaled and intravenous anesthetics are calculated	intraoperative 2-6 hours
Secondary	time to successfully extubate the nasotracheal tube after anesthesia	early extubation allowable	from the end of surgery to the post-anesthesia care, assessed up to one hour
Secondary	safely discharged from post-anesthesia care unit (postoperative recovery room)	as calculating the time from patient is delivered to postoperative recovery room to be safely discharged from recovery room by using the aldrete scores (activities level, respiration, circulation, conscious level, oxygenation) full back to pre-operative level or ten scores.	2 hours
Secondary	side effects and adverse events	records any abnormal surgical or anesthesia related findings during this admission	intraoperative and postoperative stages, assessed up to 48 hours