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

NCT04081909 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-09-09

No results posted yet for this study

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.

Conditions

  • Intravenous Anesthesia

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2020-05-04
Completion
2020-10-04

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04081909 on ClinicalTrials.gov