ClinicalTrials.gg
RecruitingNCT07323043Updated Jul 8, 2026

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

An interventional study of Tegilerdine and Sufentanil in General Anesthetic Drug Adverse Reaction, sponsored by The First People's Hospital of Lianyungang. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by The First People's Hospital of Lianyungang · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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 0.2-0.4 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.

02

Conditions studied

  • General Anesthetic Drug Adverse Reaction
03

In context

Lead sponsor

The First People's Hospital of Lianyungang is the lead sponsor of 21 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
190 participants (estimated)

Study arms

  • Experimental
    Tegilerdine group

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

    Drug: Tegilerdine

  • Active comparator
    Sufentanil group

    Administer sufentanil 0.2-0.4 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

  • DrugTegilerdine

    Inject Tegilerdine in the induction of general anesthesia

  • Inject Sufentanil in the induction of general anesthesia

06

What researchers measure

Primary outcomes

  1. Incidence of choking cough response

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

    Time frame: 2 minutes after administration

Secondary outcomes

  1. 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

    Time frame: 2 minutes after administration

  2. Blood pressure

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

    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)

  3. Heart rate

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

    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)

  4. Adverse reaction

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

    Time frame: 2 minutes after administration

07

Study locations

1 of 1 sites recruiting
  • The Affiliated Lianyungang Hospital of Xuzhou Medical University
    Lianyungang, Jiangsu, China
    Recruiting
    • Xiaobao Zhang, Doctor · Contact18961322507
    • ALHOXM · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2026 (actual). Primary completion is estimated for Aug 2026, 7 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 23, 2025
First posted
Jan 7, 2026
StartActual
Jan 15, 2026
Primary completionEst.
Aug 16, 2026
CompletionEst.
Oct 13, 2026
Last update
Jul 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07323043
Lead sponsor
The First People's Hospital of Lianyungang
Responsible party
Sponsor
First posted
Jan 7, 2026
Start date
Jan 15, 2026
Primary completion
Aug 16, 2026 (estimated)
Completion
Oct 13, 2026 (estimated)
Last update
Jul 8, 2026

Study contacts

Xiaobao Zhang, Doctor
Contact
hotdog100@163.coom
18961322507
Xiaobao Zhang, Doctor
study director · Xuzhou Medical University Affiliated Hospital of Lianyungang: Lianyungang No 1 People's Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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