Advanced Multimodal Anesthesia Care for Patients Undergoing Oro-maxillofacial Surgery

NCT05485246 | Unknown DMC

• 1 other identifier: KMUHIRB-F(I)-20210211
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthognathic Surgery

Keywords

orthognathic surgery; anesthesia; prospective analysis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• time to successfully extubate the nasotracheal tube after anesthesia

  from the end of surgery to the post-anesthesia care, assessed up to one hour

• safely discharged from post-anesthesia care unit (postoperative recovery room)

  2 hours

• side effects and adverse events

  intraoperative and postoperative stages, assessed up to 48 hours

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients without obviously systemic diseases who presentation of abnormal oro-maxillofacial anatomy needs to be corrected.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Sanmin Dist, 80756, Taiwan

Location

Study Officials

• Kuang-I Cheng, Phd

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2022
• First Posted: August 3, 2022
• Study Start: August 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 7, 2023

Record last verified: 2022-12

Locations

TW (1)