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NCT04081909

Opioid Based Anaesthesia vs Opioid Free Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.

Status unknown Phase 4 Last updated 9 September 2019
What this trial tests

Phase 4 trial testing Fentanyl,Remifentanil in Intravenous Anesthesia in 60 participants. Status unknown.

Timeline
4 September 2019
Primary endpoint
4 May 2020
4 October 2020

Quick facts

Lead sponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
PhasePhase 4
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment60
Start date4 September 2019
Primary completion4 May 2020
Estimated completion4 October 2020

Drugs / interventions tested

Conditions studied

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.

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Other Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University trials

Trials by the same sponsor.

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Data sources for this page

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