Sufentanil-induced CoughNCT05532449
Dezoxide Suppresses Sufentanil-induced Cough
A study testing Intravenous dizocine in people with Sufentanil-induced Cough, run by Shanghai Zhongshan Hospital.
Trial summary
Dizocine (0.03 mg/kg) or saline followed by sufentanil 0.4ug/kg was administered, and induction was completed with 3 min of observation. Heart rate and mean arterial pressure (MAP) were recorded before induction of anesthesia, before and 1 min after intubation, and side effects during induction, such as vomiting… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sufentanil-induced Cough
- What is being tested?
- Intravenous dizocine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- 12 Sep 2022to 30 Sep 2023
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted for elective valve surgery, artificial vessel replacement or coronary artery bypass graft surgery; Age 18~80 years old; Sex is not limited; ASA class II~III; NYHA Class II-III; Patients or their family members have signed the clinical trial informed consent form
Who cannot join
- Upper respiratory tract infection within the last two weeks; Long history of smoking; chronic obstructive pulmonary disease; Highly reactive airway diseases such as bronchitis and asthma; Presence of high cranial pressure, high eye pressure, pulmonary alveolus; Malignant tumor, hematological disease, severe liver and kidney dysfunction, recent serious infection, etc.
About this study
Official title: Low-dose Dezoxide Suppresses Sufentanil-induced Cough During Induction of General Anesthesia in Patients Undergoing Cardiac Surgery: a Prospective, Randomized, Controlled Trial
Dizocine (0.03 mg/kg) or saline followed by sufentanil 0.4ug/kg was administered, and induction was completed with 3 min of observation. Heart rate and mean arterial pressure (MAP) were recorded before induction of anesthesia, before and 1 min after intubation, and side effects during induction, such as vomiting, hypoxemia (SpO2 <90%), or other expected effects. The number of coughs was recorded in both groups, and the severity of cough was defined as follows: mild, 1-2 coughs; moderate, 3-4 coughs; severe, 5 or more coughs.
- Conditions
- Sufentanil-induced Cough
- Being tested
- Intravenous dizocine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous dizocineDrug
Intravenous dizocine (0.03mg/kg diluted to 5 ml)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| Dezocine | Experimental | intravenous dezocine (0.03mg/kg diluted to 5 ml) Receives: Drug: Intravenous dizocine |
What is being measured
The primary outcome is the main question the study is designed to answer.
sufentanil-induced cough
rate and severity of cough after sufentanil injection
Measured: 2 minutes after intubation
Secondary outcomes (3)
heart rate
heart rate during induction of general anesthesia
Measured: 2 minutes after intubation
mean arterial pressure
mean arterial pressure during induction of general anesthesia
Measured: 2 minutes after intubation
SpO2
SpO2 during induction of general anesthesia
Measured: 2 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start12 Sep 2022 (estimated)
- Primary completion12 Sep 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sufentanil-induced CoughStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532449
- Sponsor's protocol ID
- 2022 Dezocine
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Dezoxide Suppresses Sufentanil-induced Cough During Induction of General Anesthesia in Patients Undergoing Cardiac Surgery: a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05532449
- Acronym / sponsor ID
- 2022 Dezocine
- Conditions
- Sufentanil-induced Cough
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 12 Sep 2022 (estimated)
- Primary completion
- 12 Sep 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 8 Sep 2022 (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.
Dizocine (0.03 mg/kg) or saline followed by sufentanil 0.4ug/kg was administered, and induction was completed with 3 min of observation. Heart rate and mean arterial pressure (MAP) were recorded before induction of anesthesia, before and 1 min after intubation, and side effects during induction, such as vomiting, hypoxemia (SpO2 <90%), or other expected effects. The number of coughs was recorded in both groups, and the severity of cough was defined as follows: mild, 1-2 coughs; moderate, 3-4 coughs; severe, 5 or more coughs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| Dezocine | Experimental | Drug: Intravenous dizocineintravenous dezocine (0.03mg/kg diluted to 5 ml) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted for elective valve surgery, artificial vessel replacement or coronary artery bypass graft surgery; Age 18~80 years old; Sex is not limited; ASA class II~III; NYHA Class II-III; Patients or their family members have signed the clinical trial informed consent form
Key exclusion criteria (1 listed)
- Upper respiratory tract infection within the last two weeks; Long history of smoking; chronic obstructive pulmonary disease; Highly reactive airway diseases such as bronchitis and asthma; Presence of high cranial pressure, high eye pressure, pulmonary alveolus; Malignant tumor, hematological disease, severe liver and kidney dysfunction, recent serious infection, etc.
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 |
|---|---|---|
| Intravenous dizocineIntravenous dizocine (0.03mg/kg diluted to 5 ml) | Drug | Dezocine |
Primary outcome
sufentanil-induced cough
Time frame: 2 minutes after intubation
rate and severity of cough after sufentanil injection
3 secondary outcomes
heart rate
Time frame: 2 minutes after intubation
mean arterial pressure
Time frame: 2 minutes after intubation
SpO2
Time frame: 2 minutes after intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous dizocine in people with Sufentanil-induced Cough, run by Shanghai Zhongshan Hospital.
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 1 inclusion and 1 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 8 Sep 2022. 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.
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?
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?
sufentanil-induced cough (time frame: 2 minutes after intubation). 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 8 Sep 2022.