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NCT Number: NCT07323043

Effect of Tegileridine Versus Sufentanil as Analgesic Components on Opioid-Induced Cough During Anesthesia Induction

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Lianyungang Hospital of Xuzhou Medical University

Lianyungang, Jiangsu, China

Location status: Recruiting

Location contact

ALHOXM

CONTACT

Xiaobao Zhang, Doctor

CONTACT

18961322507

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tegilerdine

Drug

Inject Tegilerdine in the induction of general anesthesia

Sufentanil

Drug

Inject Sufentanil in the induction of general anesthesia

Primary outcomes

  1. Incidence of choking cough response

    Time frame: 2 minutes after administration

    Two minutes after administration of the study drugs (Tegilerdine/Sufentanil), any clear coughing action is considered an 'occurrence'.

Secondary outcomes

  1. Grading of choking and coughing response

    Time frame: 2 minutes after administration

    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. 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)

    Blood pressure before and after administration, and before and after intubation

  3. 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)

    heart rate before and after administration, and before and after intubation

  4. Adverse reaction

    Time frame: 2 minutes after administration

    such as respiratory depression, vomiting, nausea, itching, etc.)

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaobao Zhang, Doctor

CONTACT

[email protected]

18961322507

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Lianyungang

Other

Registry information

Official study title

The Affiliated Lianyungang Hospital of Xuzhou Medical University

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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