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Review of Anaesthetic Practice in Orthognathic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04813289
Recruitment Status : Completed
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Study Description
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Brief Summary:
Orthognathic surgeries for maxillofacial deformities are commonly performed globally. However, they are associated with significant blood loss which can affect the surgical field and result in blood transfusion and its risks. We aim to review the different hypotensive anaesthetic practices for orthognathic surgeries, and their effects on intraoperative blood loss and transfusion requirements.

Condition or disease
Maxillofacial Abnormalities Blood Pressure Anesthesia

Study Design
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Study Type : Observational
Actual Enrollment : 269 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Review of Anaesthetic Practice and Intraoperative Blood Loss in Orthognathic Surgery in a Tertiary Hospital
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : December 31, 2019
Groups and Cohorts
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Group/Cohort
Anaesthesia type
  1. Inhalational anaesthesia without Remifentanil use
  2. Inhalational anaesthesia with Remifentanil use
  3. Total intravenous anaesthesia
Blood pressure monitoring
  1. Intraarterial line use
  2. Non-invasive blood pressure monitoring


Outcome Measures
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Primary Outcome Measures :
  1. Anaesthesia technique [ Time Frame: Perioperative ]
    Most common modality for anaesthesia maintenance


Secondary Outcome Measures :
  1. Blood pressure monitoring [ Time Frame: Perioperative ]
    If the use of IA line vs NIBP affected patient outcomes in terms of blood loss


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who were scheduled for orthognathic surgeries from January 2014 to March 2017 were included.Patients were excluded from the study if surgery was not done or there were missing anaesthetic records.
Criteria

Inclusion Criteria:

  • All patients who were scheduled for orthognathic surgeries from January 2014 to March 2017

Exclusion Criteria:

  • surgery was not done
  • there were missing anaesthetic records
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04813289


Locations
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Singapore
Singapore General Hospital
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
More Information
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT04813289    
Other Study ID Numbers: 2016/3153
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Maxillofacial Abnormalities
Congenital Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
 Musculoskeletal Diseases
Stomatognathic System Abnormalities
Stomatognathic Diseases