Intravenous Anesthesia
Conditions
Keywords
Opioid, Ketamine, Dexmedetomidine, Sevoflurane, Perioperative complications
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.
Interventions
DRUGFentanyl，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.
DRUGKetamine,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.
Sponsors
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory depression | 24 hours following surgery | Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) \<90%) during the first postoperative night's sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 24 hours | 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. |
| hemodynamic changes | Intraoperative | blood pressure |
Contacts
Primary ContactYu Sun, MD,PhD
Backup ContactWenyue Hu, MM
Outcome results
None listed