Awake Tracheal IntubationPhase 4NCT02673723
The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation
A Phase 4 study testing Docozine and Saline in people with Awake Tracheal Intubation, run by The First Affiliated Hospital of Anhui Medical University at 4 sites in China.
Trial summary
Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to find a safe and effective method for intubation. Awake tracheal intubation which is used to retain spontaneous breathing is one of the important measures to ensure the safety of the patients with difficult airway in anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Awake Tracheal Intubation
- What is being tested?
- Docozine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 4 sitesChina
- Study dates
- Mar 2016to Dec 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent；
- Selective surgery and general anesthesia patients；
- Age 18-65 yrs；
- Anesthesia Society of American (ASA) Scale I~II；
Who cannot join
- Mallampatis Ⅲ-Ⅳ；
- Heat rate < 50 beats/minutes；
- II-III Atrioventricular block；
- Use of alpha agonist or antagonist within two weeks；
- Use of opioid within 24 hours；
- Serious heart, liver, kidney disease and cerebrovascular disease；
Show all 10Show fewer
- Allergic to the trial drug and other anesthesia drug contraindication；
- Factors existed that affect language communication；
- Any respiratory disease；
- Unsuccessful intubation for 3 times or drop out during intubation.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Anqing Municipal Hospital
Anqing, Anhui, 231402
Chaohu Affiliated Hospital of Anhui Medical University
Chaohu, Anhui, 238000
Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
The second People's Hospital of Wuhu
Wuhu, Anhui, 241000
About this study
Official title: The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation-a Multiple Center, Randomized, Controlled，Double Blinded Clinical Trial
Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to find a safe and effective method for intubation. Awake tracheal intubation which is used to retain spontaneous breathing is one of the important measures to ensure the safety of the patients with difficult airway in anesthesia.
Sufentanil is used to provide good analgesia and can effectively inhibit the reaction of awake tracheal intubation, however, the outstanding problem is serious respiratory depression after intravenous sufentanil injection. Few study showed that dezocine is a kappa opioid antagonist related to mild respiratory depression and can prevents sufentanil-induced cough during general anesthesia induction.It is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dezocine prevents sufentanil-induced respiratory depression and whether dezocine combined sufentanil is a safe and effective method for awake tracheal intubation.
- Conditions
- Awake Tracheal Intubation
- Being tested
- Docozine, Saline
- Keywords
- docozine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocozineDrug
dezocine（Dez A：0.05 mg/kg，Dez B：0.1 mg/kg and Dez C：0.15 mg/kg, diluted to 5 ml respectively) is given for 10 seconds after surface anesthesia
SalineDrug
The same amount of saline is given for 10 seconds after surface anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Dezocine | Experimental | Dezocine（Dez A：0.05 mg/kg，Dez B：0.1 mg/kg and Dez C：0.15 mg/kg, diluted to 5 ml respectively) is given for 10 seconds after surface anesthesia Receives: Drug: Docozine |
| Controlled | Placebo comparator | The same amount of saline is given for 10 seconds after surface anesthesia Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation assessment
Observer's assessment of alertness/sedation(OAA/S) scale is used to assess the depth of sedation during anesthesia induction
Measured: anesthesia induction
The occurrence of cough response
The cough scale is used to assess cough response the during anesthesia induction
Measured: anesthesia induction
The variation of blood pressure
The variation of blood pressure（mmHg) during anesthesia induction
Measured: anesthesia induction
The variation of heart rate
The variation of heart rate(bpm）during anesthesia induction
Measured: anesthesia induction
The variation of pulse oxygen saturation
The variation of pulse oxygen saturation(%) during anesthesia induction
Measured: anesthesia induction
Secondary outcomes (2)
The occurrence of cardiovascular events
The incidence of hypertension, hypotension, tachycardia and bradycardia from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery is recorded
Measured: from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery
The occurrence of treatment-related adverse events
The incidence of treatment-related adverse events as assessed by CTCAE v4.0
Measured: from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awake Tracheal IntubationStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinqi Cheng, The First Affiliated Hospital of Anhui Medical University
- Investigators
- Wei Er Gu, PhD,MD, Principal investigator, First affiliated Hospital of Anhui Medical University Locations: China,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673723
- Sponsor's protocol ID
- FirstHAnhuiMU
- Status last verified
- Feb 2019
- First submitted
- 23 Jan 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Docozine Combined With Sufentanil for Awake Tracheal Intubation-a Multiple Center, Randomized, Controlled，Double Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT02673723
- Acronym / sponsor ID
- FirstHAnhuiMU
- Conditions
- Awake Tracheal Intubation
- Keywords
- docozine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 4 Feb 2016 (estimated)
- 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.
Mortality associated with difficult airway in anesthesia is up to 30%. So, it is urgent to find a safe and effective method for intubation. Awake tracheal intubation which is used to retain spontaneous breathing is one of the important measures to ensure the safety of the patients with difficult airway in anesthesia.
Sufentanil is used to provide good analgesia and can effectively inhibit the reaction of awake tracheal intubation, however, the outstanding problem is serious respiratory depression after intravenous sufentanil injection. Few study showed that dezocine is a kappa opioid antagonist related to mild respiratory depression and can prevents sufentanil-induced cough during general anesthesia induction.It is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dezocine prevents sufentanil-induced respiratory depression and whether dezocine combined sufentanil is a safe and effective method for awake tracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dezocine | Experimental | Drug: DocozineDezocine（Dez A：0.05 mg/kg，Dez B：0.1 mg/kg and Dez C：0.15 mg/kg, diluted to 5 ml respectively) is given for 10 seconds after surface anesthesia |
| Controlled | Placebo comparator | Drug: SalineThe same amount of saline is given for 10 seconds after surface anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent；
- Selective surgery and general anesthesia patients；
- Age 18-65 yrs；
- Anesthesia Society of American (ASA) Scale I~II；
Key exclusion criteria (10 listed)
- Mallampatis Ⅲ-Ⅳ；
- Heat rate < 50 beats/minutes；
- II-III Atrioventricular block；
- Use of alpha agonist or antagonist within two weeks；
- Use of opioid within 24 hours；
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 |
|---|---|---|
| Docozinedezocine（Dez A：0.05 mg/kg，Dez B：0.1 mg/kg and Dez C：0.15 mg/kg, diluted to 5 ml respectively) is given for 10 seconds after surface anesthesia | Drug | Dezocine |
| SalineThe same amount of saline is given for 10 seconds after surface anesthesia | Drug | Controlled |
Primary outcome
Sedation assessment
Time frame: anesthesia induction
Observer's assessment of alertness/sedation(OAA/S) scale is used to assess the depth of sedation during anesthesia induction
The occurrence of cough response
Time frame: anesthesia induction
The cough scale is used to assess cough response the during anesthesia induction
The variation of blood pressure
Time frame: anesthesia induction
The variation of blood pressure（mmHg) during anesthesia induction
The variation of heart rate
Time frame: anesthesia induction
The variation of heart rate(bpm）during anesthesia induction
The variation of pulse oxygen saturation
Time frame: anesthesia induction
The variation of pulse oxygen saturation(%) during anesthesia induction
2 secondary outcomes
The occurrence of cardiovascular events
Time frame: from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery
The occurrence of treatment-related adverse events
Time frame: from beginning of the anesthesia to the time the patients discharge, up to 3rd day after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: Undecided
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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.
Wei Er Gu, PhD,MD principal investigator
First affiliated Hospital of Anhui Medical University Locations: China,
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Docozine and Saline in people with Awake Tracheal Intubation, run by The First Affiliated Hospital of Anhui Medical University at 4 sites in China.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation assessment (time frame: anesthesia induction). The study lists 5 primary outcomes in all. 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 15 Feb 2019.