An interventional study of Sufentanil Citrate in Cough, sponsored by Shiyou Wei. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Shiyou Wei · Not applicable, Interventional, and Prevention
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.
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.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Shiyou Wei is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Sufentanil Citrate
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.
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.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Peri-induction hemodynamic changes
Hemodynamic changes recorded during sufentanil infusion observation window.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Hypotension
Hypotension is defined as systolic blood pressure \< 90 mmHg or mean arterial pressure (MAP) \< 60 mmHg.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Bradycardia
Bradycardia is defined as heart rate \< 50 beats per minute.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Injection pain
Pain induced by drug injection, assessed immediately after intravenous drug administration.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Chest wall rigidity
Chest wall rigidity is defined as opioid-induced increased tone of thoracic and abdominal muscles leading to reduced chest-wall compliance and difficulty with manual or mechanical ventilation.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Respiratory depression
Respiratory depression is defined as the presence of at least one of the following: respiratory rate (RR) \< 8 breaths per minute in adults; arterial oxygen saturation (SpO₂) \< 90 mmHg despite oxygen supplementation; shallow, slow and ineffective ventilation accompanied by somnolence or reduced level of consciousness (excessive sedation); arterial blood gas showing PaCO₂ \>50 mmHg together with pH \<7.30.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Allergic reaction
Allergic reaction is defined as drug-mediated hypersensitivity manifestations occurring after intravenous injection, including skin rash, urticaria, flushing, bronchospasm, hypotension or other immune-mediated adverse events.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Dizziness
Dizziness is defined as a subjective sensation of light-headedness or unsteadiness reported by the subject following study drug administration.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Palpitation
Palpitation is defined as the subject-reported unpleasant awareness of abnormal or forceful heartbeats after study drug injection.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Hypoxemia
Peripheral oxygen saturation SpO₂ \<92% on pulse oximetry.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Pruritus
Subject reports generalized or local pruritus after sufentanil administration.
Time frame: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Plan to share: No
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Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.
Of 78 non-industry interventional studies with no phase under Cough, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 1 month is below that.
Counting every sponsor, half of 86 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sufentanil
Shiyou Wei