Maxillofacial AbnormalitiesNCT04813289
Review of Anaesthetic Practice in Orthognathic Surgery
An observational study of Maxillofacial Abnormalities and Blood Pressure, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maxillofacial Abnormalities, Blood Pressure, Anesthesia
- Type of treatment
- Injection or infusion
- How many people
- 269 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- All patients who were scheduled for orthognathic surgeries from January 2014 to March 2017
Who cannot join
- surgery was not done
- there were missing anaesthetic records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Review of Anaesthetic Practice and Intraoperative Blood Loss in Orthognathic Surgery in a Tertiary Hospital
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.
- Conditions
- Maxillofacial Abnormalities, Blood Pressure, Anesthesia
- Medical subject headings
- Maxillofacial Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaesthesia technique
Most common modality for anaesthesia maintenance
Measured: Perioperative
Secondary outcomes (1)
Blood pressure monitoring
If the use of IA line vs NIBP affected patient outcomes in terms of blood loss
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start1 Jul 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813289
- Sponsor's protocol ID
- 2016/3153
- Status last verified
- Mar 2021
- First submitted
- 21 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review of Anaesthetic Practice and Intraoperative Blood Loss in Orthognathic Surgery in a Tertiary Hospital
- ClinicalTrials.gov ID
- NCT04813289
- Acronym / sponsor ID
- 2016/3153
- Conditions
- Maxillofacial Abnormalities, Blood Pressure, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- All patients who were scheduled for orthognathic surgeries from January 2014 to March 2017
Key exclusion criteria (2 listed)
- surgery was not done
- there were missing anaesthetic records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anaesthesia technique
Time frame: Perioperative
Most common modality for anaesthesia maintenance
1 secondary outcome
Blood pressure monitoring
Time frame: Perioperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillofacial Abnormalities and Blood Pressure, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anaesthesia technique (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.