CoughNCT07778953
90% Effective Infusion Time of Sufentanil to Prevent Induction Cough: A Biased Coin Sequential Study
A study testing Sufentanil Citrate in people with Cough, run by Shiyou Wei at 1 site in China.
Trial summary
This single-center, prospective biased coin up-and-down sequential study aims to determine the 90% effective infusion time (ET90) of sufentanil to prevent sufentanil-induced cough (SIC) during the induction phase of general anesthesia in adults undergoing endotracheal intubation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cough
- What is being tested?
- Sufentanil Citrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III
- Aged ≥18 ears old
- Scheduled for elective surgery requiring general anesthesia with tracheal intubation
Who cannot join
- Resting vital signs upon operating-room arrival: systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100 mmHg, or heart rate ≥110 beats per minute.
- Anticipated difficult airway, requirement for rapid-sequence induction, or emergency surgery.
- Chronic cough, asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, active pulmonary disease, or upper respiratory tract infection within the preceding 2 weeks.
- Regular opioid use for more than 2 weeks within 6 months before surgery; or recent use of antitussive agents or other medications that may alter the cough reflex.
- Known history of allergy to study drug (sufentanil citrate).
- Pregnancy, lactation, psychiatric disorders, or individuals unable to communicate appropriately.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shaoyang University Affiliated First Hospital
Shaoyang, Hunan, 422000
Yadan Liu, 18229421255, lyd26897@163.com
About this study
Official title: Determination of the 90% Effective Infusion Time of Sufentanil to Prevent Sufentanil-Induced Cough During General Anesthesia Induction in Young and Elderly Patients: A Biased Coin Design Up-and-Down Sequential Study
This single-center, prospective biased coin up-and-down sequential study aims to determine the 90% effective infusion time (ET90) of sufentanil to prevent sufentanil-induced cough (SIC) during the induction phase of general anesthesia in adults undergoing endotracheal intubation. Two age cohorts are studied separately: younger adults (<65 years) and older adults (≥65 years). The trial does not test superiority or between-group differences as the primary objective.
All participants receive sufentanil via a peripheral intravenous pump. The total sufentanil dose is fixed within each age cohort (young: 0.40 μg/kg; elderly: 0.30 μg/kg), while the pump injection time is adjusted using the biased coin up-and-down allocation method. SIC success is defined as no audible cough within a prespecified observation window from the start of the infusion until 2 minutes after infusion ends.
The primary outcome is the ET90 of sufentanil and its 95% confidence interval for each age cohort, estimated using centered isotonic regression with bootstrap confidence intervals. Approximately 120 patients will be screened to obtain at least 54 evaluable participants per cohort.
Read the detailed description
This is a single-center, prospective sequential study using a biased coin up-and-down allocation approach to determine the 90% effective infusion time (ET90) of sufentanil during the induction phase of general anesthesia to prevent sufentanil-induced cough (SIC). The study evaluates two age groups separately: younger adults (<65 years) and older adults (≥65 years).
Sufentanil will be administered intravenously via a infusion pump. Within each age cohort, the total sufentanil dose is predetermined, while the infusion time (rate) is adjusted based on the previous participant's outcome according to the biased coin up-and-down rule.
The primary success criterion is the absence of SIC during a prespecified observation period that starts at sufentanil infusion initiation and ends shortly after infusion completion during the induction phase. The primary outcome is the ET90, estimated for each age cohort with an appropriate statistical model using the observed infusion times and SIC outcomes.
Participants are screened before surgery based on age and general anesthesia requirements, and key comorbidities and contraindications are considered to reduce confounding. Safety is monitored throughout the induction phase and perioperative period, with attention to potential adverse events including hemodynamic instability and respiratory depression.
Approximately 120 patients are planned for enrollment to obtain sufficient evaluable participants in each cohort for ET90 estimation.
- Conditions
- Cough
- Being tested
- Sufentanil Citrate
- Keywords
- sufentanil-induced cough, general anesthesia induction, endotracheal intubation, infusion time
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sufentanil CitrateDrug
Sufentanil citrate administered via peripheral intravenous syringe pump during general anesthesia induction. Fixed weight-based total dose within each age sub-cohort; infusion time varies according to biased-coin up-and-down sequential rules.
| Study group | Role | What they receive |
|---|---|---|
| Single Interventional Arm | Experimental | All enrolled participants receive sufentanil citrate injection, infused via peripheral intravenous syringe pump during general anesthesia induction.
Two independent age-defined sequential sub-cohorts are included within this single arm:
1. Younger adult sub-cohort (<65 years): fixed sufentanil total dose 0.40 μg/kg actual body weight.
2. Older adult sub-cohort (≥65 years): fixed sufentanil total dose 0.30 μg/kg actual body weight.
Within each sub-cohort, the sufentanil infusion time is adjusted sequentially by biased-coin up-and-down rule according to the previous participant's sufentanil-induced cough (SIC) outcome. No other prophylactic anti-cough medications are given during the SIC observation window. After completion of the observation period, standard general anesthesia induction will be performed according to institutional routine. Receives: Drug: Sufentanil Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
90% effective infusion time (ET90) of sufentanil for preventing sufentanil-induced cough (SIC)
ET90 is defined as the shortest sufentanil infusion time achieving no SIC in 90% of participants, estimated separately for younger adults (<65 years) and older adults (≥65 years) using centered isotonic regression with bootstrap 95% confidence intervals. SIC is defined as any audible cough within the predefined observation window.
Measured: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Secondary outcomes (1)
Incidence and severity of sufentanil-induced cough (SIC)
SIC severity graded: mild (1-2 coughs), moderate (3-4 coughs), severe (≥5 coughs). Count of cough episodes and SIC incidence at each infusion-time level, reported separately for two age sub-cohorts.
Measured: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Nov 2026 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a biased-coin up-and-down sequential design study. Two independent sequential cohorts are enrolled separately: younger adults (\<65 years) and older adults (≥65 years). Within each cohort, infusion time is adjusted sequentially according to the prior participant's SIC outcome. No separate control arm is included.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiyou Wei
- Sponsor type
- University, hospital or other
- Collaborators
- Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China
- Responsible party
- Sponsor-investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Xin Lv, Principal investigator, Shanghai Pulmonary Hospital, School of Medicine, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778953
- Sponsor's protocol ID
- Shaoyang-002
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the 90% Effective Infusion Time of Sufentanil to Prevent Sufentanil-Induced Cough During General Anesthesia Induction in Young and Elderly Patients: A Biased Coin Design Up-and-Down Sequential Study
- ClinicalTrials.gov ID
- NCT07778953
- Acronym / sponsor ID
- Shaoyang-002
- Conditions
- Cough
- Keywords
- sufentanil-induced cough, general anesthesia induction, endotracheal intubation, infusion time
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Collaborators
- Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Aug 2026 (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.
This single-center, prospective biased coin up-and-down sequential study aims to determine the 90% effective infusion time (ET90) of sufentanil to prevent sufentanil-induced cough (SIC) during the induction phase of general anesthesia in adults undergoing endotracheal intubation. Two age cohorts are studied separately: younger adults (<65 years) and older adults (≥65 years). The trial does not test superiority or between-group differences as the primary objective.
All participants receive sufentanil via a peripheral intravenous pump. The total sufentanil dose is fixed within each age cohort (young: 0.40 μg/kg; elderly: 0.30 μg/kg), while the pump injection time is adjusted using the biased coin up-and-down allocation method. SIC success is defined as no audible cough within a prespecified observation window from the start of the infusion until 2 minutes after infusion ends.
The primary outcome is the ET90 of sufentanil and its 95% confidence interval for each age cohort, estimated using centered isotonic regression with bootstrap confidence intervals. Approximately 120 patients will be screened to obtain at least 54 evaluable participants per cohort.
Detailed description
This is a single-center, prospective sequential study using a biased coin up-and-down allocation approach to determine the 90% effective infusion time (ET90) of sufentanil during the induction phase of general anesthesia to prevent sufentanil-induced cough (SIC). The study evaluates two age groups separately: younger adults (<65 years) and older adults (≥65 years).
Sufentanil will be administered intravenously via a infusion pump. Within each age cohort, the total sufentanil dose is predetermined, while the infusion time (rate) is adjusted based on the previous participant's outcome according to the biased coin up-and-down rule.
The primary success criterion is the absence of SIC during a prespecified observation period that starts at sufentanil infusion initiation and ends shortly after infusion completion during the induction phase. The primary outcome is the ET90, estimated for each age cohort with an appropriate statistical model using the observed infusion times and SIC outcomes.
Participants are screened before surgery based on age and general anesthesia requirements, and key comorbidities and contraindications are considered to reduce confounding. Safety is monitored throughout the induction phase and perioperative period, with attention to potential adverse events including hemodynamic instability and respiratory depression.
Approximately 120 patients are planned for enrollment to obtain sufficient evaluable participants in each cohort for ET90 estimation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a biased-coin up-and-down sequential design study. Two independent sequential cohorts are enrolled separately: younger adults (<65 years) and older adults (≥65 years). Within each cohort, infusion time is adjusted sequentially according to the prior participant's SIC outcome. No separate control arm is included.
| Arm | Type | Receives |
|---|---|---|
| Single Interventional Arm | Experimental | Drug: Sufentanil CitrateAll enrolled participants receive sufentanil citrate injection, infused via peripheral intravenous syringe pump during general anesthesia induction. Two independent age-defined sequential sub-cohorts are included within this single arm: 1. Younger adult sub-cohort (<65 years): fixed sufentanil total dose 0.40 μg/kg actual body weight. 2. Older adult sub-cohort (≥65 years): fixed sufentanil total dose 0.30 μg/kg actual body weight. Within each sub-cohort, the sufentanil infusion time is adjusted sequentially by biased-coin up-and-down rule according to the previous participant's sufentanil-induced cough (SIC) outcome. No other prophylactic anti-cough medications are given during the SIC observation window. After completion of the observation period, standard general anesthesia induction will be performed according to institutional routine. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I-III
- Aged ≥18 ears old
- Scheduled for elective surgery requiring general anesthesia with tracheal intubation
Key exclusion criteria (6 listed)
- Resting vital signs upon operating-room arrival: systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100 mmHg, or heart rate ≥110 beats per minute.
- Anticipated difficult airway, requirement for rapid-sequence induction, or emergency surgery.
- Chronic cough, asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, active pulmonary disease, or upper respiratory tract infection within the preceding 2 weeks.
- Regular opioid use for more than 2 weeks within 6 months before surgery; or recent use of antitussive agents or other medications that may alter the cough reflex.
- Known history of allergy to study drug (sufentanil citrate).
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 |
|---|---|---|
| Sufentanil CitrateSufentanil citrate administered via peripheral intravenous syringe pump during general anesthesia induction. Fixed weight-based total dose within each age sub-cohort; infusion time varies according to biased-coin up-and-down sequential rules. | Drug | Single Interventional Arm |
Primary outcome
90% effective infusion time (ET90) of sufentanil for preventing sufentanil-induced cough (SIC)
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
ET90 is defined as the shortest sufentanil infusion time achieving no SIC in 90% of participants, estimated separately for younger adults (<65 years) and older adults (≥65 years) using centered isotonic regression with bootstrap 95% confidence intervals. SIC is defined as any audible cough within the predefined observation window.
1 secondary outcome
Incidence and severity of sufentanil-induced cough (SIC)
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Xin Lv principal investigator
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sufentanil Citrate in people with Cough, run by Shiyou Wei at 1 site 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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyou Wei, Doc (15601680288, lovewishyou@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90% effective infusion time (ET90) of sufentanil for preventing sufentanil-induced cough (SIC) (time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)). 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 21 Aug 2026.