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

Primary Purpose

Intravenous Anesthesia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Fentanyl,Remifentanil
Ketamine,Dexmedetomidine
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intravenous Anesthesia focused on measuring Opioid, Ketamine, Dexmedetomidine, Sevoflurane, Perioperative complications

Eligibility Criteria

3 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Opioid Based Anesthesia(OBA)

    Opioid Free Anesthesia(OFA)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Respiratory depression
    Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) <90%) during the first postoperative night's sleep

    Secondary Outcome Measures

    Incidence of postoperative nausea and vomiting in the recovery room
    Incidence of postoperative nausea and vomiting on day 1
    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.
    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)
    hemodynamic changes
    blood pressure
    hemodynamic changes
    heart rate

    Full Information

    First Posted
    September 5, 2019
    Last Updated
    September 6, 2019
    Sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04081909
    Brief Title
    Opioid Based Anaesthesia vs Opioid Free Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
    Official Title
    Opioid Free Anaesthesia vs Opioid Based Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 4, 2019 (Anticipated)
    Primary Completion Date
    May 4, 2020 (Anticipated)
    Study Completion Date
    October 4, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intravenous Anesthesia
    Keywords
    Opioid, Ketamine, Dexmedetomidine, Sevoflurane, Perioperative complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Opioid Based Anesthesia(OBA)
    Arm Type
    Active Comparator
    Arm Title
    Opioid Free Anesthesia(OFA)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl,Remifentanil
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine,Dexmedetomidine
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Respiratory depression
    Description
    Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) <90%) during the first postoperative night's sleep
    Time Frame
    24 hours following surgery
    Secondary Outcome Measure Information:
    Title
    Incidence of postoperative nausea and vomiting in the recovery room
    Time Frame
    first 2 postoperative hours
    Title
    Incidence of postoperative nausea and vomiting on day 1
    Time Frame
    1st postoperative day
    Title
    Severity of postoperative pain
    Description
    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.
    Time Frame
    24 hours
    Title
    Severity of postoperative pain
    Description
    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)
    Time Frame
    24 hours
    Title
    hemodynamic changes
    Description
    blood pressure
    Time Frame
    Intraoperative
    Title
    hemodynamic changes
    Description
    heart rate
    Time Frame
    Intraoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu Sun, MD,PhD
    Phone
    0086-136-1189-5542
    Email
    dr_sunyu@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wenyue Hu, MM
    Phone
    0086-180-1918-0376
    Email
    huwenyue08@163.com

    12. IPD Sharing Statement

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

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