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NCT04081909
Opioid Based Anaesthesia vs Opioid Free Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
Phase 4 trial testing Fentanyl,Remifentanil in Intravenous Anesthesia in 60 participants. Status unknown.
4 May 2020
Quick facts
| Lead sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 4 September 2019 |
| Primary completion | 4 May 2020 |
| Estimated completion | 4 October 2020 |
Drugs / interventions tested
- Fentanyl,Remifentanil — full drug profile →
- Ketamine,Dexmedetomidine — full drug profile →
Conditions studied
- Intravenous Anesthesia — all drugs for Intravenous Anesthesia →
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Who can join
Adults 3 Months to 12, any sex, with Intravenous Anesthesia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Peri-operative opioid administration has long been one of the three pillars of 'balanced anaesthesia',over the span of just a few years,opioids were widely used in perioperative analgesia because of pain as the fifth vital sign.However, opioid administration is not without concern and is associated with many side-effects such as constipation, urinary retention, respiratory depression and postoperative nausea and vomiting .Cleft lip,palate,alveolus are common craniofacial abnormalities and usually require surgical repair.These patients have risks for various perioperative complications due to their young age and craniofacial abnormalities. This study was designed to compare the effects of opioid based anesthesia(OBA) and opioid free anesthesia(OFA )on perioperative complications in patients with in cleft lip,palate,alveolus surgery, including respiratory depression, postoperative nausea and vomiting, hemodynamic effects, etc.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04081909
- Europe PMC full search
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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 NCT04081909 (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 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Last refreshed: 9 September 2019
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/NCT04081909.
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