Comparison of Cough Response Between Tegilidine and Sufentanil as Pre-induction Agents in General Anesthesia

The First People's Hospital of Lianyungang

Status: Enrolling

Conditions: General Anesthetic Drug Adverse Reaction

Treatments: Drug: Tegilidine; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT07323043

KY-20250815003-01

Details and patient eligibility

About

In patients undergoing general anesthesia with planned tracheal intubation , a prospective, randomized, controlled, double-blind study was conducted to record the occurrence of cough 2 minutes after injection of Sufentanil or tegilidine. 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.

Full 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 0.4 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30;
2. ASA grade I ~ III;
3. Scheduled elective surgery under general anesthesia with tracheal intubation.

Exclusion criteria

1. Patients with chronic cough (cough lasting >8 weeks) or asthma;
2. Patients with a history of allergy to the drugs used during the study;
3. Patients with severe cardiovascular disease, intracranial lesions, eye lesions, or lung lesions.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups

Tegilidine group

Experimental group

Description:

Administer 20-50ug/kg of Tegilidine before induction of general anesthesia, and record the patient's coughing episodes 2 minutes after administration. Then proceed with anesthesia induction.

Treatment:

Drug: Tegilidine

Sufentanil group

Active Comparator group

Description:

Administer sufentanil 0.4 µg/kg before the induction of general anesthesia, and record the patient's coughing episodes 2 minutes after administration. Then proceed with anesthesia induction.

Treatment:

Drug: Sufentanil