90% Effective Infusion Time of Sufentanil to Prevent Induction Cough: A Biased Coin Sequential Study
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Shiyou Wei, Doc
- Telefonní číslo: 15601680288
- E-mail: lovewishyou@tongji.edu.cn
Studijní místa
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Hunan
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Shaoyang, Hunan, Čína, 422000
- Shaoyang University Affiliated First Hospital
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Kontakt:
- Yadan Liu
- Telefonní číslo: 18229421255
- E-mail: lyd26897@163.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-III
- Aged ≥18 ears old
- Scheduled for elective surgery requiring general anesthesia with tracheal intubation
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Single Interventional Arm
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:
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. |
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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90% effective infusion time (ET90) of sufentanil for preventing sufentanil-induced cough (SIC)
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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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.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence and severity of sufentanil-induced cough (SIC)
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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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.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Peri-induction hemodynamic changes
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Hemodynamic changes recorded during sufentanil infusion observation window.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Hypotension
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Hypotension is defined as systolic blood pressure < 90 mmHg or mean arterial pressure (MAP) < 60 mmHg.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Bradycardia
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Bradycardia is defined as heart rate < 50 beats per minute.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Injection pain
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Pain induced by drug injection, assessed immediately after intravenous drug administration.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Chest wall rigidity
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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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.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Respiratory depression
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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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.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Allergic reaction
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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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.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Dizziness
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Dizziness is defined as a subjective sensation of light-headedness or unsteadiness reported by the subject following study drug administration.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Palpitation
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Palpitation is defined as the subject-reported unpleasant awareness of abnormal or forceful heartbeats after study drug injection.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Hypoxemia
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Peripheral oxygen saturation SpO₂ <92% on pulse oximetry.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Pruritus
Časové okno: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Subject reports generalized or local pruritus after sufentanil administration.
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From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Xin Lv, Shanghai Pulmonary Hospital, School of Medicine, Tongji University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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