NCT04081909

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 3 Months – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intravenous Anesthesia

Interventions

Type	Name	Description
DRUG	Fentanyl，Remifentanil	Patients in OBA ,anesthesia induction will receive fentanyl 2ug/kg ,propofol 1% 2-3mg/kg, rocuronium 0.6-1mg/kg. Anesthesia maintenance with 1.5-2% sevoflurane, propofol 1% 3-6mg/kg/hr , remifentanil of 0.1- 0.2ug/ kg/ min.
DRUG	Ketamine,Dexmedetomidine	Patients in OFA,anesthesia induction will receive ketamine 1 mg/kg ,propofol 1% 2-3mg/kg, rocuronium 0.6-1mg/kg. Anesthesia maintenance with 1.5-2% sevoflurane, propofol 1% 3-6mg/kg/hr , dexmedetomidine of 0.4-0.8ug/ kg/ hr.

Timeline

• Start date: 2019-09-04
• Primary completion: 2020-05-04
• Completion: 2020-10-04
• First posted: 2019-09-09
• Last updated: 2019-09-09