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

NCT07323043 | Recruiting DMC

• 1 other identifier: KY-20250815003-01
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

General Anesthetic Drug Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Grading of choking and coughing response

  2 minutes after administration

• Blood pressure

  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

  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

  2 minutes after administration

Study Arms (2)

Tegilidine group

EXPERIMENTAL

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

Sufentanil group

ACTIVE COMPARATOR

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

Interventions

Tegilidine DRUG

Inject Tegilidine in the induction of general anesthesia

Tegilidine group

Sufentanil DRUG

Inject Sufentanil in the induction of general anesthesia

Sufentanil group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Lianyungang: lead

Study Sites (1)

The Affiliated Lianyungang Hospital of Xuzhou Medical University

Lianyungang, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

Sufentanil

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiaobao Zhang, Doctor

  Xuzhou Medical University Affiliated Hospital of Lianyungang: Lianyungang No 1 People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaobao Zhang, Doctor

CONTACT

18961322507; hotdog100@163.coom

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: January 7, 2026
• Study Start: January 15, 2026
• Primary Completion: May 16, 2026
• Study Completion (Estimated): June 16, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

CN (1)