Enhanced Recovery After SurgeryNCT04596774
The Impact of Enhanced Recovery After Surgery in Orthognathic Surgery
An observational study of Enhanced Recovery After Surgery and Hospital Stay, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Aim: Orthognathic surgeries are generally associated with blood loss, swelling, postoperative nausea vomiting (PONV), and pain. The aim of this study is to improve postoperative outcome in patients undergoing orthognatic surgeries by the use of Enhanced Recovery After Surgery (ERAS) protocols. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Enhanced Recovery After Surgery, Hospital Stay, Postoperative Nausea and Vomiting
- What is being tested?
- Traditional Approach and Enhanced Recovery After Surgery (ERAS) Approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 30 Aug 2020
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients eligible for orthognathic surgery Patients who were operated under either the traditional approach or the Enhanced Recovery After Surgery (ERAS) approach Patients aged between 18 and 40 years of age American Society of Anesthesiologists (ASA) physical status of 1-2
Who may be able to join
- Patients undergoing orthognathic surgery (bimaxillary, mandibular/maxillary)
- Patients aged between 18 and 40 years of age
- American Society of Anesthesiologists (ASA) physical status of 1-2
- Capable of understanding the instructions for using the NRS pain scores
- Capable of replying the study-based questions
- Absence of mental/psychiatric disorders
- Absence of chronic analgesic/opioid use
- Absence of alcohol/illicit drug use
Who cannot join
- Patients who are younger than 18 years of age
- Patients who are older than 45 years of age
- American Society of Anesthesiologists (ASA) physical status of 3-4
- Not capable of consenting
- Not capable of understanding the instructions for using the NRS pain
- scores
Show all 10Show fewer
- Not capable of replying the study-based questions
- Presence of mental/psychiatric disorders
- Presence of chronic analgesic/opioid use
- Presence of alcohol/illicit drug use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul, 34093
About this study
Official title: The Impact of Using Enhanced Recovery After Surgery Approach on Orthognathic Surgery Outcome: A Historical Cohort Study
Aim: Orthognathic surgeries are generally associated with blood loss, swelling, postoperative nausea vomiting (PONV), and pain. The aim of this study is to improve postoperative outcome in patients undergoing orthognatic surgeries by the use of Enhanced Recovery After Surgery (ERAS) protocols.
Material methods: After Ethics Committee approval (2020/965), the data of 90 patients who underwent elective orthognathic surgery, were investigated. Following standard monitorization and general anesthesia; Group 1 patients were applied traditional approach and received intraoperative 10 mL/kg/h IV izolen infusion. Group 2 received ERAS approach. Patients in Group 2 did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours, and received 6 mL/kg/h IV izolen intraoperatively. In these; gastric aspiration was also applied before extubation, PONV prophylaxis and patient controlled analgesia was added to the routine plans for the first postoperative 48 hours. The primary endpoint was length of hospital stay. The secondary endpoints were intraoperative follow-up data, length of postanesthesia care unit (PACU) stay, numeric rating scale (NRS) pain scores, opioid consumption and PONV incidences through the postoperative first 48 hours, and satisfaction scores.
Read the detailed description
Aim: Orthognathic surgeries are extensive surgeries including both soft and hard tissues of the facial region of the skull associated with blood loss, inflammatory reactions, massive swelling, postoperative nausea vomiting (PONV), and severe pain. Therefore; in most of the patients who are with dentofacial deformity and undergo orthognathic surgery, postoperative recovery generally requires a long troublesome period. The aim of this study is to improve postoperative outcome by the use of Enhanced Recovery After Surgery (ERAS) protocols.
Material methods: After Ethics Committee approval (2020/965), the data of 90 patients who underwent elective orthognathic surgery, were investigated. Following standard monitorization and general anesthesia; Group 1 patients were applied traditional approach and received intraoperative 10 mL/kg/h IV izolen infusion. Rescue analgesics and PONV prophylaxis were applied when required through the postoperative first 48 hours. Group 2 received ERAS approach. Patients in Group 2 did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours, and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was also applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours. The primary endpoint was length of hospital stay. The secondary endpoints were intraoperative follow-up data, numeric rating scale (NRS) pain scores, opioid consumption, PONV incidences, length of postanesthesia care unit (PACU) stay, satisfaction scores of two groups through the postoperative first 48 hours.
- Conditions
- Enhanced Recovery After Surgery, Hospital Stay, Postoperative Nausea and Vomiting, Pain, Postoperative
- Being tested
- Traditional Approach, Enhanced Recovery After Surgery (ERAS) Approach
- Keywords
- Orthognathic surgery, Enhanced recovery after surgery (ERAS), Analgesia, Postoperative nausea vomiting (PONV), Satisfaction
- Medical subject headings
- Postoperative Nausea and Vomiting, Pain, Postoperative, Agnosia, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional ApproachProcedure or surgery
Patients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required.
Enhanced Recovery After Surgery (ERAS) ApproachProcedure or surgery
Patients did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1 patients were applied traditional approach. Patients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required. Receives: Procedure: Traditional Approach | |
| Group 2 | Group 2 received Enhanced Recovery After Surgery (ERAS) approach. Patients did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours. Receives: Procedure: Enhanced Recovery After Surgery (ERAS) Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Post Anaesthetic Discharge Scoring System (PADSS) (≥9/10)
Measured: 0-48 hours
Secondary outcomes (14)
Mean arterial pressure (MAP)
Intraoperative follow-up
Measured: 0-5 hours
Heart rate
Intraoperative follow-up
Measured: 0-5 hours
Intraoperative fentanyl requirement
Intraoperative follow-up
Measured: 0-5 hours
The amount of blood loss
Intraoperative follow-up (aspirator and gases)
Measured: 0-5 hours
The difference of preoperative-postoperative haemoglobin values
Preop Hb-Postop Hb
Measured: 0-12 hours
Length of stay in postoanesthesia care unit (PACU)
Modified Aldrete Scoring system (≥9/10)
Measured: 0-1 hours
Pain (Numeric rating scale (NRS)) scores
Postoperative Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)
Measured: 0-48 hours
Opioid (meperidine) consumption
Amount of opioid administered to the patient through the postoperative first 48 hours (Group 1: NRS≥4, Group 2: Patient controlled analgesia system)
Measured: 0-48 hours
Incidence of postoperative nausea and vomiting (PONV)
Number of feeling nausea or vomiting (on postoperative days 1 and 2)
Measured: 0-48 hours
Postoperative first oral intake
First oral liquid (water) intake time (postoperatively as soon as possible)
Measured: 0-24 hours
Postoperative first passage of flatus or stool
First passage of flatus or stool (postoperatively as soon as possible)
Measured: 0-24 hours
Postoperative first mobilization
First mobilization time (standing up-walking for any reason) (postoperatively as soon as possible)
Measured: 0-24 hours
Patient satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Measured: 0-48 hours
Surgeon satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Aug 2018
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Aysu Salviz, MD, Istanbul University
- Investigators
- Emine A Salviz, MD,AssocProf, Principal investigator, Study Principal Investigator, Corresponding author
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596774
- Sponsor's protocol ID
- 2020/965
- Status last verified
- Oct 2020
- First submitted
- 18 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dobbeleir M, De Coster J, Coucke W, Politis C. Postoperative nausea and vomiting after oral and maxillofacial surgery: a prospective study. Int J Oral Maxillofac Surg. 2018 Jun;47(6):721-725. doi: 10.1016/j.ijom.2017.11.018. Epub 2018 Jan 1.
PubMed 29301675Lin S, McKenna SJ, Yao CF, Chen YR, Chen C. Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Oral Maxillofac Surg. 2017 Jan;75(1):73-86. doi: 10.1016/j.joms.2016.07.012. Epub 2016 Jul 25.
PubMed 27542543Mobini A, Mehra P, Chigurupati R. Postoperative Pain and Opioid Analgesic Requirements After Orthognathic Surgery. J Oral Maxillofac Surg. 2018 Nov;76(11):2285-2295. doi: 10.1016/j.joms.2018.05.014. Epub 2018 May 19.
PubMed 29886112Agbaje J, Luyten J, Politis C. Pain Complaints in Patients Undergoing Orthognathic Surgery. Pain Res Manag. 2018 Jul 15;2018:4235025. doi: 10.1155/2018/4235025. eCollection 2018.
PubMed 30123397
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Using Enhanced Recovery After Surgery Approach on Orthognathic Surgery Outcome: A Historical Cohort Study
- ClinicalTrials.gov ID
- NCT04596774
- Acronym / sponsor ID
- 2020/965
- Conditions
- Enhanced Recovery After Surgery, Hospital Stay, Postoperative Nausea and Vomiting, Pain, Postoperative
- Keywords
- Orthognathic surgery, Enhanced recovery after surgery (ERAS), Analgesia, Postoperative nausea vomiting (PONV), Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 22 Oct 2020 (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.
Aim: Orthognathic surgeries are generally associated with blood loss, swelling, postoperative nausea vomiting (PONV), and pain. The aim of this study is to improve postoperative outcome in patients undergoing orthognatic surgeries by the use of Enhanced Recovery After Surgery (ERAS) protocols.
Material methods: After Ethics Committee approval (2020/965), the data of 90 patients who underwent elective orthognathic surgery, were investigated. Following standard monitorization and general anesthesia; Group 1 patients were applied traditional approach and received intraoperative 10 mL/kg/h IV izolen infusion. Group 2 received ERAS approach. Patients in Group 2 did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours, and received 6 mL/kg/h IV izolen intraoperatively. In these; gastric aspiration was also applied before extubation, PONV prophylaxis and patient controlled analgesia was added to the routine plans for the first postoperative 48 hours. The primary endpoint was length of hospital stay. The secondary endpoints were intraoperative follow-up data, length of postanesthesia care unit (PACU) stay, numeric rating scale (NRS) pain scores, opioid consumption and PONV incidences through the postoperative first 48 hours, and satisfaction scores.
Detailed description
Aim: Orthognathic surgeries are extensive surgeries including both soft and hard tissues of the facial region of the skull associated with blood loss, inflammatory reactions, massive swelling, postoperative nausea vomiting (PONV), and severe pain. Therefore; in most of the patients who are with dentofacial deformity and undergo orthognathic surgery, postoperative recovery generally requires a long troublesome period. The aim of this study is to improve postoperative outcome by the use of Enhanced Recovery After Surgery (ERAS) protocols.
Material methods: After Ethics Committee approval (2020/965), the data of 90 patients who underwent elective orthognathic surgery, were investigated. Following standard monitorization and general anesthesia; Group 1 patients were applied traditional approach and received intraoperative 10 mL/kg/h IV izolen infusion. Rescue analgesics and PONV prophylaxis were applied when required through the postoperative first 48 hours. Group 2 received ERAS approach. Patients in Group 2 did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours, and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was also applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours. The primary endpoint was length of hospital stay. The secondary endpoints were intraoperative follow-up data, numeric rating scale (NRS) pain scores, opioid consumption, PONV incidences, length of postanesthesia care unit (PACU) stay, satisfaction scores of two groups through the postoperative first 48 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Traditional ApproachGroup 1 patients were applied traditional approach. Patients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required. |
| Group 2 | – | Procedure: Enhanced Recovery After Surgery (ERAS) ApproachGroup 2 received Enhanced Recovery After Surgery (ERAS) approach. Patients did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients eligible for orthognathic surgery Patients who were operated under either the traditional approach or the Enhanced Recovery After Surgery (ERAS) approach Patients aged between 18 and 40 years of age American Society of Anesthesiologists (ASA) physical status of 1-2
Key inclusion criteria (8 listed)
- Patients undergoing orthognathic surgery (bimaxillary, mandibular/maxillary)
- Patients aged between 18 and 40 years of age
- American Society of Anesthesiologists (ASA) physical status of 1-2
- Capable of understanding the instructions for using the NRS pain scores
- Capable of replying the study-based questions
Key exclusion criteria (10 listed)
- Patients who are younger than 18 years of age
- Patients who are older than 45 years of age
- American Society of Anesthesiologists (ASA) physical status of 3-4
- Not capable of consenting
- Not capable of understanding the instructions for using the NRS pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional ApproachPatients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required. | Procedure or surgery | Group 1 |
| Enhanced Recovery After Surgery (ERAS) ApproachPatients did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours. | Procedure or surgery | Group 2 |
Primary outcome
Length of hospital stay
Time frame: 0-48 hours
Post Anaesthetic Discharge Scoring System (PADSS) (≥9/10)
14 secondary outcomes
Mean arterial pressure (MAP)
Time frame: 0-5 hours
Heart rate
Time frame: 0-5 hours
Intraoperative fentanyl requirement
Time frame: 0-5 hours
The amount of blood loss
Time frame: 0-5 hours
The difference of preoperative-postoperative haemoglobin values
Time frame: 0-12 hours
Length of stay in postoanesthesia care unit (PACU)
Time frame: 0-1 hours
Pain (Numeric rating scale (NRS)) scores
Time frame: 0-48 hours
Opioid (meperidine) consumption
Time frame: 0-48 hours
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 0-48 hours
Postoperative first oral intake
Time frame: 0-24 hours
Postoperative first passage of flatus or stool
Time frame: 0-24 hours
Postoperative first mobilization
Time frame: 0-24 hours
Patient satisfaction
Time frame: 0-48 hours
Surgeon satisfaction
Time frame: 0-48 hours
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 22 Oct 2020.
- Results publication: PubMed 29301675Dobbeleir M, De Coster J, Coucke W, Politis C. Postoperative nausea and vomiting after oral and maxillofacial surgery: a prospective study. Int J Oral Maxillofac Surg. 2018 Jun;47(6):721-725. doi: 10.1016/j.ijom.2017.11.018. Epub 2018 Jan 1.
- Results publication: PubMed 27542543Lin S, McKenna SJ, Yao CF, Chen YR, Chen C. Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Oral Maxillofac Surg. 2017 Jan;75(1):73-86. doi: 10.1016/j.joms.2016.07.012. Epub 2016 Jul 25.
- Results publication: PubMed 29886112Mobini A, Mehra P, Chigurupati R. Postoperative Pain and Opioid Analgesic Requirements After Orthognathic Surgery. J Oral Maxillofac Surg. 2018 Nov;76(11):2285-2295. doi: 10.1016/j.joms.2018.05.014. Epub 2018 May 19.
- Results publication: PubMed 30123397Agbaje J, Luyten J, Politis C. Pain Complaints in Patients Undergoing Orthognathic Surgery. Pain Res Manag. 2018 Jul 15;2018:4235025. doi: 10.1155/2018/4235025. eCollection 2018.
- 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.
Emine A Salviz, MD,AssocProf principal investigator
Study Principal Investigator, Corresponding author
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 Enhanced Recovery After Surgery and Hospital Stay, run by Istanbul University at 1 site in Turkey (Türkiye).
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 8 inclusion and 10 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 22 Oct 2020. 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 Turkey (Türkiye). 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?
Length of hospital stay (time frame: 0-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04596774, which also lists 4 linked publications.
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 22 Oct 2020.