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

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Intravenous Anesthesia

Treatments: Drug: Ketamine,Dexmedetomidine; Drug: Fentanyl，Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT04081909

OFA vs OBA

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 3 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Opioid Based Anesthesia(OBA)

Active Comparator group

Treatment:

Drug: Fentanyl，Remifentanil

Opioid Free Anesthesia(OFA)

Experimental group

Treatment:

Drug: Ketamine,Dexmedetomidine