Effect of Tegileridine Versus Sufentanil as Analgesic Components on Opioid-Induced Cough During Anesthesia Induction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tegilerdine, Sufentanil.
- Who it may be relevant to
- Registry conditions: General Anesthetic Drug Adverse Reaction. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Affiliated Lianyungang Hospital of Xuzhou Medical University
Overview
In patients undergoing general anesthesia with planned tracheal intubation , a prospective, randomized, controlled study was conducted to record the occurrence of cough 2 minutes after injection of Sufentanil or Tegilerdine. The cough was graded based on the frequency and duration: Grade I, no cough; Grade II, a single mild cough; Grade III, multiple coughs with duration \<1 second; Grade IV, continuous coughing with a duration \>15 seconds.
Detailed description
Using a computer-generated randomized number table, patients were divided into two groups: the experimental group receiving Tiliglitidine (T group) at 20-50ug/kg, and the control group receiving Sufentanil (S group) at 0.2-0.4 μg/kg. After patients arrived in the operating room, routine monitoring including non-invasive blood pressure, electrocardiogram, and oxygen saturation was performed, and intravenous access was established. Patients were oxygenated and given the study drug before anesthesia induction. No other drugs were administered to the patients before giving the study drug. During anesthesia induction, patients received intravenous injection of Tiliglitide or Sufentanil according to their group. The severity of coughing was graded based on the number of coughing episodes: graded by the number and duration of coughs: Grade I, no cough, breathing regular; Grade II, a single mild cough; Grade III, multiple coughs, lasting less than 15 seconds; Grade IV, continuous coughs, lasting more than 15 seconds.
Interventions
- Drug Tegilerdine
Inject Tegilerdine in the induction of general anesthesia - Drug Sufentanil
Inject Sufentanil in the induction of general anesthesia
Primary outcome measures
- Incidence of choking cough response [Time frame: 2 minutes after administration]
Secondary outcome measures (4)
- Grading of choking and coughing response [Time frame: 2 minutes after administration]
- Blood pressure [Time frame: before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4）]
- Heart rate [Time frame: before injection of Tegilerdine or Sufentanil (T0), 2 minutes after injection (T1), 1 minute before intubation (T2), 1 minute after intubation (T3), and 3 minutes after intubation (T4）]
- Adverse reaction [Time frame: 2 minutes after administration]
Eligibility criteria
Inclusion criteria
- Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30;
- ASA grade I \~ III;
- Scheduled elective surgery under general anesthesia with tracheal intubation.
Exclusion criteria
- Patients with chronic cough (cough lasting >8 weeks) or asthma;
- Patients with a history of allergy to the drugs used during the study;
- Patients with severe cardiovascular disease, intracranial lesions, eye lesions, or lung lesions.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
China · 1 center
- The Affiliated Lianyungang Hospital of Xuzhou Medical University — Lianyungang
Identifiers
NCT: NCT07323043 · KY-20250815003-01