NCT04813289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

March 21, 2021

Last Update Submit

March 21, 2021

Conditions

Maxillofacial AbnormalitiesBlood PressureAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Anaesthesia technique

    Most common modality for anaesthesia maintenance

    Perioperative

Secondary Outcomes (1)

  • Blood pressure monitoring

    Perioperative

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • surgery was not done
  • there were missing anaesthetic records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Maxillofacial Abnormalities

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2021

First Posted

March 24, 2021

Study Start

July 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)