Opioid Free Anaesthesia vs Opioid Based Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
Overview
- Phase
- Phase 4
- Intervention
- Fentanyl，Remifentanil
- Conditions
- Intravenous Anesthesia
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Enrollment
- 60
- Primary Endpoint
- Respiratory depression
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Yu Sun
Principal Investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Eligibility Criteria
Inclusion Criteria
- •American Society Anesthesia I, II；
- •Age between 3 months and 12 years;
Exclusion Criteria
- •allergy to anesthetic and analgesic drugs;
- •history of neuromuscular;
- •renal, neurological, hepatic disease;
- •cardiopulmonary diseases;
- •bradycardia
Arms & Interventions
Opioid Based Anesthesia(OBA)
Intervention: Fentanyl，Remifentanil
Opioid Free Anesthesia(OFA)
Intervention: Ketamine,Dexmedetomidine
Outcomes
Primary Outcomes
Respiratory depression
Time Frame: 24 hours following surgery
Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) \<90%) during the first postoperative night's sleep
Secondary Outcomes
- Incidence of postoperative nausea and vomiting in the recovery room(first 2 postoperative hours)
- Severity of postoperative pain(24 hours)
- Incidence of postoperative nausea and vomiting on day 1(1st postoperative day)
- hemodynamic changes(Intraoperative)