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

Intravenous Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04081909
• Other study ID #: OFA vs OBA
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 4, 2019
• Est. completion date: October 4, 2020

Study information

• Verified date: September 2019
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Yu Sun, MD,PhD
• Phone: 0086-136-1189-5542
• Email: dr_sunyu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 4, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Intravenous Anesthesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of postoperative nausea and vomiting in the recovery room		first 2 postoperative hours
Secondary	Incidence of postoperative nausea and vomiting on day 1		1st postoperative day
Secondary	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
Secondary	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
Secondary	hemodynamic changes	blood pressure	Intraoperative
Secondary	hemodynamic changes	heart rate	Intraoperative