Cough
Conditions
Keywords
sufentanil-induced cough, general anesthesia induction, endotracheal intubation, infusion time
Brief 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. 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.
Interventions
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.
Sponsors
Shiyou Wei
Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90% effective infusion time (ET90) of sufentanil for preventing sufentanil-induced cough (SIC) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of sufentanil-induced cough (SIC) | 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. |
Countries
China
Contacts
CONTACTShiyou Wei, Doc
PRINCIPAL_INVESTIGATORXin Lv
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
Outcome results
None listed