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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

Tracking Information
First Submitted Date  ICMJE September 5, 2019
First Posted Date  ICMJE September 9, 2019
Last Update Posted Date September 9, 2019
Estimated Study Start Date  ICMJE September 4, 2019
Estimated Primary Completion Date May 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
  • Incidence of postoperative nausea and vomiting in the recovery room [ Time Frame: first 2 postoperative hours ]
  • Incidence of postoperative nausea and vomiting on day 1 [ Time Frame: 1st postoperative day ]
  • 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.
  • 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)
  • hemodynamic changes [ Time Frame: Intraoperative ]
    blood pressure
  • hemodynamic changes [ Time Frame: Intraoperative ]
    heart rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Based Anaesthesia vs Opioid Free Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
Official Title  ICMJE Opioid Free Anaesthesia vs Opioid Based Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Intravenous Anesthesia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Opioid Based Anesthesia(OBA)
    Intervention: Drug: Fentanyl,Remifentanil
  • Experimental: Opioid Free Anesthesia(OFA)
    Intervention: Drug: Ketamine,Dexmedetomidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 6, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 4, 2020
Estimated Primary Completion Date May 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04081909
Other Study ID Numbers  ICMJE OFA vs OBA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Study Sponsor  ICMJE Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP