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Clinical Trials/NCT05485246
NCT05485246
Enrolling By Invitation
Not Applicable

Advanced Multimodal Anesthesia Care for Patients Undergoing Oro-maxillofacial Surgery

Kaohsiung Medical University Chung-Ho Memorial Hospital1 site in 1 country80 target enrollmentAugust 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthognathic Surgery
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Enrollment
80
Locations
1
Primary Endpoint
permitted hypotension during surgery with adequate depth of anesthesia and cardiac output
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2022
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

permitted hypotension during surgery with adequate depth of anesthesia and cardiac output

Time Frame: intraoperative 2-6 hours

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

consumption of inhaled and intravenous anesthetics

Time Frame: intraoperative 2-6 hours

to maintain adequate depth of anesthesia during intentional hypotension, consumptions of inhaled and intravenous anesthetics are calculated

Secondary Outcomes

  • time to successfully extubate the nasotracheal tube after anesthesia(from the end of surgery to the post-anesthesia care, assessed up to one hour)
  • side effects and adverse events(intraoperative and postoperative stages, assessed up to 48 hours)
  • safely discharged from post-anesthesia care unit (postoperative recovery room)(2 hours)

Study Sites (1)

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