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90% Effective Infusion Time of Sufentanil to Prevent Induction Cough: A Biased Coin Sequential Study

19 augustus 2026 bijgewerkt door: Shiyou Wei

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Hunan
      • Shaoyang, Hunan, China, 422000
        • Shaoyang University Affiliated First Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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:

  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.
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
90% effective infusion time (ET90) of sufentanil for preventing sufentanil-induced cough (SIC)
Tijdsspanne: 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.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence and severity of sufentanil-induced cough (SIC)
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Peri-induction hemodynamic changes
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Hemodynamic changes recorded during sufentanil infusion observation window.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Hypotension
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Hypotension is defined as systolic blood pressure < 90 mmHg or mean arterial pressure (MAP) < 60 mmHg.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Bradycardia
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Bradycardia is defined as heart rate < 50 beats per minute.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Injection pain
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Pain induced by drug injection, assessed immediately after intravenous drug administration.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Chest wall rigidity
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Respiratory depression
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Allergic reaction
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
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.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Dizziness
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Dizziness is defined as a subjective sensation of light-headedness or unsteadiness reported by the subject following study drug administration.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Palpitation
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Palpitation is defined as the subject-reported unpleasant awareness of abnormal or forceful heartbeats after study drug injection.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Hypoxemia
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Peripheral oxygen saturation SpO₂ <92% on pulse oximetry.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Pruritus
Tijdsspanne: From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)
Subject reports generalized or local pruritus after sufentanil administration.
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Shiyou Wei

Medewerkers

Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China

Onderzoekers

  • Hoofdonderzoeker: Xin Lv, Shanghai Pulmonary Hospital, School of Medicine, Tongji University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

25 december 2026

Studie voltooiing (Geschat)

30 december 2026

Studieregistratiedata

Eerst ingediend

19 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 augustus 2026

Eerst geplaatst (Werkelijk)

21 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

19 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Shaoyang-002

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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