Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07323043

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

Led by The First People's Hospital of Lianyungang · Updated on 2026-02-04

190

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the cough response in patients undergoing general anesthesia with planned tracheal intubation. This prospective, randomized, controlled, double-blind study compares the occurrence of cough two minutes after injection of either Tegilidine or Sufentanil. The study aims to grade coughing severity based on frequency and duration to better understand drug reactions during anesthesia induction. Patients are randomly assigned to one of two groups: an experimental group receiving Tegilidine at a dose of 20-50 µg/kg, or a control group receiving Sufentanil at 0.4 µg/kg. After arriving in the operating room, patients undergo routine monitoring including blood pressure, electrocardiogram, and oxygen saturation measurements. The assigned study drug is administered intravenously before anesthesia induction, and no other drugs are given prior to this. Coughing episodes are recorded and graded two minutes after drug administration. Participants will be monitored for blood pressure and heart rate at multiple time points before and after drug administration and intubation. The main outcome measured is the incidence of coughing two minutes after drug injection. Secondary outcomes include the severity grading of coughing, vital signs at specified intervals, and monitoring for any adverse reactions. The study involves elective surgery patients aged 18 to 65 years and includes careful observation during anesthesia induction and intubation periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years with a body mass index (BMI) between 18 and 30 kg/m²
  • ASA grade I to III
  • Scheduled for elective surgery under general anesthesia with tracheal intubation
Not Eligible

You will not qualify if you...

  • Chronic cough lasting more than 8 weeks or asthma
  • History of allergy to drugs used in the study
  • Severe cardiovascular disease, intracranial lesions, eye lesions, or lung lesions

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day during surgery

Participants receive an injection of either Tegilidine or Sufentanil before induction of general anesthesia. Coughing response and vital signs are monitored shortly after administration and during anesthesia induction.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

The Affiliated Lianyungang Hospital of Xuzhou Medical University

Lianyungang, Jiangsu, China

Actively Recruiting

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Research Team

X

Xiaobao Zhang, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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