90% Effective Infusion Time of Sufentanil to Prevent Induction Cough: A Biased Coin Sequential Study
ConditionCough
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorShiyou Wei
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status I-III
Aged ≥18 ears old
Scheduled for elective surgery requiring general anesthesia with tracheal intubation
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Sufentanil Citrate
DrugSufentanil 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Single Interventional ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)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.
Time frame
From start of sufentanil infusion until 2 minutes after the end of sufentanil infusion (anesthesia induction period)Other outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shiyou Wei
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Sponsor institution
Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China
Collaborator
Source ClinicalTrials.gov
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