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
About this trial
This is an interventional prevention trial for Intravenous Anesthesia focused on measuring Opioid, Ketamine, Dexmedetomidine, Sevoflurane, Perioperative complications
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
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
NCT ID
NCT04081909
First Posted
September 5, 2019
Last Updated
September 6, 2019
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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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