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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intravenous Anesthesia

Intervention / Treatment
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* Drug: Fentanyl，Remifentanil
* Drug: Ketamine,Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioid Based Anesthesia(OBA)<br> | Drug: Fentanyl，Remifentanil<br>* 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.<br>|
| Experimental: Opioid Free Anesthesia(OFA)<br> | Drug: Ketamine,Dexmedetomidine<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory depression | Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) <90%) during the first postoperative night's sleep | 24 hours following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting in the recovery room |  | first 2 postoperative hours | 
| Incidence of postoperative nausea and vomiting on day 1 |  | 1st postoperative day | 
| Severity of postoperative pain | Comparison of the severity of postoperative pain in both group using the Face, Legs, Activity, Cry, Consolability scale for children between the ages of 3 months and 7 years. The scale has five criteria, which are each assigned a score of 0, 1 or 2.The scale is scored in a range of 0-10 with 0 representing no pain. | 24 hours | 
| Severity of postoperative pain | Comparison of the severity of postoperative pain in both group using Visual Analogue Scale for children aged 7 years and more. We instruct the patient to point to the position on the line between the faces to indicate how much pain they are currently feeling. The far left end indicates no pain(0) and the far right end indicates worst pain ever.(10) | 24 hours | 
| hemodynamic changes | blood pressure | Intraoperative | 
| hemodynamic changes | heart rate | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid, Ketamine, Dexmedetomidine, Sevoflurane, Perioperative complications