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

Phase 4

• Conditions: Intravenous Anesthesia
• Interventions: Drug: Fentanyl，Remifentanil; Drug: Ketamine,Dexmedetomidine

• Registration Number: NCT04081909
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-09-04
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-06
• Last Update Submitted: 2019-09-06
• Study First Posted: 2019-09-09
• Last Update Posted: 2019-09-09
• Primary Completion: 2020-05-04
• Study Completion: 2020-10-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Based Anesthesia(OBA)	Fentanyl，Remifentanil	-
Opioid Free Anesthesia(OFA)	Ketamine,Dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting in the recovery room	first 2 postoperative hours
Severity of postoperative pain	24 hours	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)
Incidence of postoperative nausea and vomiting on day 1	1st postoperative day
hemodynamic changes	Intraoperative	heart rate