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NCT04596774
The Impact of Enhanced Recovery After Surgery in Orthognathic Surgery
trial testing Traditional Approach in Enhanced Recovery After Surgery in 90 participants. Completed in 30 August 2020.
30 August 2020
Quick facts
| Lead sponsor | Istanbul University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 90 |
| Start date | 1 August 2018 |
| Primary completion | 30 August 2020 |
| Estimated completion | 30 August 2020 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Traditional Approach
- Enhanced Recovery After Surgery (ERAS) Approach
Conditions studied
- Enhanced Recovery After Surgery — all drugs for Enhanced Recovery After Surgery →
- Hospital Stay — all drugs for Hospital Stay →
- Postoperative Nausea and Vomiting — all drugs for Postoperative Nausea and Vomiting →
- Pain, Postoperative — all drugs for Pain, Postoperative →
Sponsor
Istanbul University
Who can join
Adults 18 to 40, any sex, with Enhanced Recovery After Surgery or Hospital Stay. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04596774
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Istanbul University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04596774 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istanbul University
- Last refreshed: 22 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04596774.
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