drugset / Trial / NCT04081909

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

NCT04081909 ↗

RandomizedParallel-groupDouble-blindPrevention

Summary

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.

Timeline

Start
2019-09-04
Primary completion
2020-05-04
Completion
2020-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.4 ug/kg —
Subject Dexmedetomidine Other / unclassified 0.8 ug/kg —
Comparator Fentanyl Other / unclassified 2 ug/kg —
Subject Ketamine Small molecule 1 mg/kg —
Comparator Remifentanil Small molecule 0.1 ug/kg —
Comparator Remifentanil Small molecule 0.2 ug/kg —

Indications

No indication recorded.