NCT04081909

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 5, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2020

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

8 months

First QC Date

September 5, 2019

Last Update Submit

September 6, 2019

Conditions

Intravenous Anesthesia

Keywords

OpioidKetamineDexmedetomidineSevofluranePerioperative complications

Outcome Measures

Primary Outcomes (1)

  • Respiratory depression

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

    24 hours following surgery

Secondary Outcomes (6)

  • 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

  • Severity of postoperative pain

    24 hours

  • Severity of postoperative pain

    24 hours

  • hemodynamic changes

    Intraoperative

  • +1 more secondary outcomes

Study Arms (2)

Opioid Based Anesthesia(OBA)

ACTIVE COMPARATOR
Drug: Fentanyl，Remifentanil

Opioid Free Anesthesia(OFA)

EXPERIMENTAL
Drug: Ketamine,Dexmedetomidine

Interventions

Fentanyl，RemifentanilDRUG

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.

Opioid Based Anesthesia(OBA)
Ketamine,DexmedetomidineDRUG

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.

Opioid Free Anesthesia(OFA)

Eligibility Criteria

Age3 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • American Society Anesthesia I, II；
  • Age between 3 months and 12 years;

You may not qualify if:

  • allergy to anesthetic and analgesic drugs;
  • history of neuromuscular;
  • renal, neurological, hepatic disease;
  • cardiopulmonary diseases;
  • bradycardia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

KetamineDexmedetomidine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Yu Sun, MD,PhD

CONTACT

0086-136-1189-5542dr_sunyu@163.com

Wenyue Hu, MM

CONTACT

0086-180-1918-0376huwenyue08@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 9, 2019

Study Start

September 4, 2019

Primary Completion

May 4, 2020

Study Completion

October 4, 2020

Last Updated

September 9, 2019

Record last verified: 2019-09