Intravenous AnesthesiaPhase 4NCT04081909
Opioid Based Anaesthesia vs Opioid Free Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
A Phase 4 study testing Fentanyl，Remifentanil and Ketamine,Dexmedetomidine in people with Intravenous Anesthesia, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Intravenous Anesthesia
- What is being tested?
- Fentanyl，Remifentanil and Ketamine,Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 4 Sep 2019to 4 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society Anesthesia I, II；
- Age between 3 months and 12 years;
Who cannot join
- allergy to anesthetic and analgesic drugs;
- history of neuromuscular;
- renal, neurological, hepatic disease;
- cardiopulmonary diseases;
- bradycardia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Opioid Free Anaesthesia vs Opioid Based Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
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.
- Conditions
- Intravenous Anesthesia
- Being tested
- Fentanyl，Remifentanil, Ketamine,Dexmedetomidine
- Keywords
- Opioid, Ketamine, Dexmedetomidine, Sevoflurane, Perioperative complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Based Anesthesia(OBA) | Active comparator | Not described Receives: Drug: Fentanyl，Remifentanil |
| Opioid Free Anesthesia(OFA) | Experimental | Not described Receives: Drug: Ketamine,Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory depression
Number of desaturation events (oxygen saturation by pulse oximetry (SPO2) <90%) during the first postoperative night's sleep
Measured: 24 hours following surgery
Secondary outcomes (6)
Incidence of postoperative nausea and vomiting in the recovery room
Measured: first 2 postoperative hours
Incidence of postoperative nausea and vomiting on day 1
Measured: 1st postoperative day
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.
Measured: 24 hours
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)
Measured: 24 hours
hemodynamic changes
blood pressure
Measured: Intraoperative
hemodynamic changes
heart rate
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start4 Sep 2019 (estimated)
- Primary completion4 May 2020 (estimated)
- Study completion4 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous AnesthesiaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Sun, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081909
- Sponsor's protocol ID
- OFA vs OBA
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free Anaesthesia vs Opioid Based Anesthesia in Cleft Lip, Palate ,Alveolus Surgery.
- ClinicalTrials.gov ID
- NCT04081909
- Acronym / sponsor ID
- OFA vs OBA
- Conditions
- Intravenous Anesthesia
- Keywords
- Opioid, Ketamine, Dexmedetomidine, Sevoflurane, Perioperative complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 4 Sep 2019 (estimated)
- Primary completion
- 4 May 2020 (estimated)
- Study completion
- 4 Oct 2020 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Based Anesthesia(OBA) | Active comparator | Drug: Fentanyl，Remifentanil |
| Opioid Free Anesthesia(OFA) | Experimental | Drug: Ketamine,Dexmedetomidine |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society Anesthesia I, II；
- Age between 3 months and 12 years;
Key exclusion criteria (5 listed)
- allergy to anesthetic and analgesic drugs;
- history of neuromuscular;
- renal, neurological, hepatic disease;
- cardiopulmonary diseases;
- bradycardia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl，RemifentanilPatients 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 | Opioid Based Anesthesia(OBA) |
| Ketamine,DexmedetomidinePatients 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. | Drug | Opioid Free Anesthesia(OFA) |
Primary outcome
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
6 secondary outcomes
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
Severity of postoperative pain
Time frame: 24 hours
hemodynamic changes
Time frame: Intraoperative
hemodynamic changes
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl，Remifentanil and Ketamine,Dexmedetomidine in people with Intravenous Anesthesia, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Sun, MD,PhD (0086-136-1189-5542, dr_sunyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory depression (time frame: 24 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.