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

• ClinicalTrials.gov Identifier: NCT04081909
• Recruitment Status: Unknown
• First Posted: September 9, 2019
• Last Update Posted: September 9, 2019
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Information provided by (Responsible Party): Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Tracking Information

• First Submitted Date: September 5, 2019
• First Posted Date: September 9, 2019
• Last Update Posted Date: September 9, 2019
• Estimated Study Start Date: September 4, 2019
• Estimated Primary Completion Date: May 4, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.

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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Intravenous Anesthesia

Intervention

• 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

• Active Comparator: Opioid Based Anesthesia(OBA)
  Intervention: Drug: Fentanyl，Remifentanil
• Experimental: Opioid Free Anesthesia(OFA)
  Intervention: Drug: Ketamine,Dexmedetomidine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 6, 2019): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 4, 2020
• Estimated Primary Completion Date: May 4, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Months to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04081909
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Study Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Verification Date: September 2019