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

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ClinicalTrials.gov Identifier: NCT04081909
Recruitment Status : Unknown
Verified September 2019 by Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Recruitment status was:  Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Intravenous Anesthesia Drug: Fentanyl，Remifentanil Drug: Ketamine,Dexmedetomidine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Opioid Free Anaesthesia vs Opioid Based Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
Estimated Study Start Date : September 4, 2019
Estimated Primary Completion Date : May 4, 2020
Estimated Study Completion Date : October 4, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Opioid Based Anesthesia(OBA) 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.
Experimental: Opioid Free Anesthesia(OFA) 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.


Outcome Measures
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Primary Outcome Measures :
  1. Respiratory depression [ Time Frame: 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 :
  1. Incidence of postoperative nausea and vomiting in the recovery room [ Time Frame: first 2 postoperative hours ]
  2. Incidence of postoperative nausea and vomiting on day 1 [ Time Frame: 1st postoperative day ]
  3. Severity of postoperative pain [ Time Frame: 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.

  4. Severity of postoperative pain [ Time Frame: 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)

  5. hemodynamic changes [ Time Frame: Intraoperative ]
    blood pressure

  6. hemodynamic changes [ Time Frame: Intraoperative ]
    heart rate


Eligibility Criteria
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Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04081909


Contacts
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Contact: Yu Sun, MD,PhD 0086-136-1189-5542 dr_sunyu@163.com
Contact: Wenyue Hu, MM 0086-180-1918-0376 huwenyue08@163.com

Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
More Information
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Responsible Party: Yu Sun, Principal Investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT04081909    
Other Study ID Numbers: OFA vs OBA
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
Opioid
Ketamine
Dexmedetomidine
Sevoflurane
Perioperative complications
Additional relevant MeSH terms:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities
Fentanyl
Dexmedetomidine
Ketamine
Remifentanil
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents