Istanbul University, Istanbul Faculty of Medicine
Istanbul, 34093, Turkey (Türkiye)
NCT Number: NCT04596774
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.
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Notify Me18 year–40 year
All sexes
Observational
Istanbul, 34093, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required.
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.
Time frame: 0-48 hours
Post Anaesthetic Discharge Scoring System (PADSS) (≥9/10)
Time frame: 0-5 hours
Intraoperative follow-up
Time frame: 0-5 hours
Intraoperative follow-up
Time frame: 0-5 hours
Intraoperative follow-up
Time frame: 0-5 hours
Intraoperative follow-up (aspirator and gases)
Time frame: 0-12 hours
Preop Hb-Postop Hb
Time frame: 0-1 hours
Modified Aldrete Scoring system (≥9/10)
Time frame: 0-48 hours
Postoperative Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)
Time frame: 0-48 hours
Amount of opioid administered to the patient through the postoperative first 48 hours (Group 1: NRS≥4, Group 2: Patient controlled analgesia system)
Time frame: 0-48 hours
Number of feeling nausea or vomiting (on postoperative days 1 and 2)
Time frame: 0-24 hours
First oral liquid (water) intake time (postoperatively as soon as possible)
Time frame: 0-24 hours
First passage of flatus or stool (postoperatively as soon as possible)
Time frame: 0-24 hours
First mobilization time (standing up-walking for any reason) (postoperatively as soon as possible)
Time frame: 0-48 hours
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Time frame: 0-48 hours
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Istanbul University
Other
The Impact of Using Enhanced Recovery After Surgery Approach on Orthognathic Surgery Outcome: A Historical Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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