Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04596774
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2020-10-18
Brief Title:
The Impact of Enhanced Recovery After Surgery in Orthognathic Surgery
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
The Impact of Using Enhanced Recovery After Surgery Approach on Orthognathic Surgery Outcome A Historical Cohort Study
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Material methods After Ethics Committee approval 2020965 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 mLkgh 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 mLkgh 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
Material methods After Ethics Committee approval 2020965 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 mLkgh 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 mLkgh 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 2020965 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 mLkgh 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 mLkgh 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
Material methods After Ethics Committee approval 2020965 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 mLkgh 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 mLkgh 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None