Review of Anaesthetic Practice in Orthognathic Surgery | NCT04813289

Studies
Review of Anaesthetic Practice in Orthognathic Surgery

NCT04813289

Sponsor

Singapore General Hospital

Status

Completed

Last Update Posted

Mar 24, 2021Actual

Enrollment

269Actual

Phase

Not provided

Conditions

Maxillofacial Abnormalities
Blood Pressure
Anesthesia

Interventions

Not provided

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Mar 21, 2021

First Submission Date that Met QC Criteria

Mar 21, 2021

First Posted Date

Mar 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2021

Last Update Posted Date

Mar 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

269Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anaesthesia type		Inhalational anaesthesia without Remifentanil use Inhalational anaesthesia with Remifentanil use Total intravenous anaesthesia
Blood pressure monitoring		Intraarterial line use Non-invasive blood pressure monitoring

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anaesthesia technique	Most common modality for anaesthesia maintenance	Perioperative

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure monitoring	If the use of IA line vs NIBP affected patient outcomes in terms of blood loss	Perioperative

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Singapore General Hospital		Singapore			Singapore

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019767	Maxillofacial Abnormalities

Ancestor Terms

ID	Term
D019465	Craniofacial Abnormalities
D009139	Musculoskeletal Abnormalities
D009140	Musculoskeletal Diseases
D018640	Stomatognathic System Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided