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

The Affiliated Lianyungang Hospital of Xuzhou Medical University

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.

Study Overview

• Status: Recruiting
• Conditions: General Anesthetic Drug Adverse Reaction
• Intervention / Treatment: Drug: Tegilidine; Drug: Sufentanil

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 0.4 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.

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaobao Zhang, Doctor; Phone Number: 18961322507; Email: hotdog100@163.coom

Study Locations

• China
  • Jiangsu
    • Lianyungang, Jiangsu, China
      • Recruiting
      • The Affiliated Lianyungang Hospital of Xuzhou Medical University
      • Contact: Xiaobao Zhang, Doctor; Phone Number: 18961322507
      • Contact: ALHOXM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sufentanil group; 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.	Drug: Sufentanil; Inject Sufentanil in the induction of general anesthesia
Experimental: Tegilidine group; 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.	Drug: Tegilidine; Inject Tegilidine in the induction of general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of choking cough response	Two minutes after administration of the study drugs (Tegilidine/Sufentanil), any clear coughing action is considered an 'occurrence'.	2 minutes after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grading of choking and coughing response	Grading based on the number and duration of coughs: Grade I, no coughing, breathing is even; Grade II, a single mild cough; Grade III, multiple coughs lasting less than 15 seconds; Grade IV, continuous coughing lasting more than 15 seconds	2 minutes after administration
Blood pressure	Blood pressure before and after administration, and before and after intubation	before injection of Tegilidine 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	heart rate before and after administration, and before and after intubation	before injection of Tegilidine 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	such as respiratory depression, vomiting, nausea, itching, etc.)	2 minutes after administration

Collaborators and Investigators

• Sponsor: The First People's Hospital of Lianyungang
• Investigators: Study Director: Xiaobao Zhang, Doctor, Xuzhou Medical University Affiliated Hospital of Lianyungang: Lianyungang No 1 People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): May 16, 2026
• Study Completion (Estimated): June 16, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Fentanyl; Sufentanil
• Other Study ID Numbers: KY-20250815003-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No