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

Ketamine

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.

Intervention / Treatment

Fentanyl，Remifentanil (DRUG)

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.
Ketamine,Dexmedetomidine (DRUG)

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.

Condition or Disease

Intravenous Anesthesia

Phase

Phase 4

Study Design

Study type:	INTERVENTIONAL
Status:	Unknown status
Study results:	No Results Available
Age:	3 Months to 12 Years
Enrollment:	60 (ESTIMATED)
Funded by:	Other
Allocation:	Randomized
Primary Purpose:	Prevention
Masking DOUBLE: Participant Outcomes Assessor

Clinical Trial Dates

Start date:	Sep 04, 2019	ESTIMATED
Primary Completion:	May 04, 2020	ESTIMATED
Completion Date:	Oct 04, 2020	ESTIMATED
Study First Posted:	Sep 09, 2019	ACTUAL
Results First Posted:	Aug 31, 2020
Last Updated:	Sep 06, 2019

Sponsors / Collaborators

Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Responsible Party: N/A

Participant Groups

No description provided
No description provided

Eligibility Criteria

Sex:	All
Maximum Age:	12
Age Groups:	Child
Healthy Volunteers:	Yes

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

Primary Outcomes

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

Secondary Outcomes

Incidence of postoperative nausea and vomiting in the recovery room first 2 postoperative hours
Incidence of postoperative nausea and vomiting on day 1 1st postoperative day
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.
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)
blood pressure
heart rate

More Details

NCT Number:	NCT04081909
Other IDs:	OFA vs OBA
Study URL:	https://clinicaltrials.gov/study/NCT04081909

Last updated: Sep 29, 2023