General Anesthetic Drug Adverse ReactionNCT07323043
Effect of Tegileridine Versus Sufentanil as Analgesic Components on Opioid-Induced Cough During Anesthesia Induction
A study testing Tegilerdine and Sufentanil in people with General Anesthetic Drug Adverse Reaction, run by The First People's Hospital of Lianyungang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthetic Drug Adverse Reaction
- What is being tested?
- Tegilerdine and Sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 13 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30;
- ASA grade I ~ III;
- Scheduled elective surgery under general anesthesia with tracheal intubation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Lianyungang Hospital of Xuzhou Medical University
Lianyungang, Jiangsu
Xiaobao Zhang, Doctor, 18961322507
ALHOXM
About this study
Official title: The Affiliated Lianyungang Hospital of Xuzhou Medical University
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.
- Conditions
- General Anesthetic Drug Adverse Reaction
- Being tested
- Tegilerdine, Sufentanil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegilerdineDrug
Inject Tegilerdine in the induction of general anesthesia
SufentanilDrug
Inject Sufentanil in the induction of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Tegilerdine group | Experimental | 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. Receives: Drug: Tegilerdine |
| Sufentanil group | Active comparator | 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. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of choking cough response
Two minutes after administration of the study drugs (Tegilerdine/Sufentanil), any clear coughing action is considered an 'occurrence'.
Measured: 2 minutes after administration
Secondary outcomes (4)
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
Measured: 2 minutes after administration
Blood pressure
Blood pressure before and after administration, and before and after intubation
Measured: 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
heart rate before and after administration, and before and after intubation
Measured: 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）
Adverse reaction
such as respiratory depression, vomiting, nausea, itching, etc.)
Measured: 2 minutes after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start15 Jan 2026
- Primary completion16 Aug 2026 (estimated)
- Study completion13 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthetic Drug Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Lianyungang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaobao Zhang, Doctor, Study director, Xuzhou Medical University Affiliated Hospital of Lianyungang: Lianyungang No 1 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323043
- Sponsor's protocol ID
- KY-20250815003-01
- Status last verified
- Jul 2026
- First submitted
- 23 Nov 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Affiliated Lianyungang Hospital of Xuzhou Medical University
- ClinicalTrials.gov ID
- NCT07323043
- Acronym / sponsor ID
- KY-20250815003-01
- Conditions
- General Anesthetic Drug Adverse Reaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- The First People's Hospital of LianyungangUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 16 Aug 2026 (estimated)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tegilerdine group | Experimental | Drug: TegilerdineAdminister 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. |
| Sufentanil group | Active comparator | Drug: SufentanilAdminister 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years, 18 ≤ BMI (kg/m²) ≤ 30;
- ASA grade I ~ III;
- Scheduled elective surgery under general anesthesia with tracheal intubation.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TegilerdineInject Tegilerdine in the induction of general anesthesia | Drug | Tegilerdine group |
| SufentanilInject Sufentanil in the induction of general anesthesia | Drug | Sufentanil group |
Primary outcome
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'.
4 secondary outcomes
Grading of choking and coughing response
Time frame: 2 minutes after administration
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）
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）
Adverse reaction
Time frame: 2 minutes after administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaobao Zhang, Doctor study director
Xuzhou Medical University Affiliated Hospital of Lianyungang: Lianyungang No 1 People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegilerdine and Sufentanil in people with General Anesthetic Drug Adverse Reaction, run by The First People's Hospital of Lianyungang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaobao Zhang, Doctor (18961322507, hotdog100@163.coom), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of choking cough response (time frame: 2 minutes after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.