CoughPhase 4NCT07660380
Oliceridine vs Sufentanil for Cough During Anesthesia Induction
A Phase 4 study testing Oliceridine and Sufentanil in people with Cough and Anesthesia, run by Shiyou Wei at 1 site in China.
Trial summary
Sufentanil is the most widely used opioid analgesic for general anaesthesia induction; however, rapid intravenous bolus injection frequently triggers sufentanil-induced cough (SIC). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cough, Anesthesia
- What is being tested?
- Oliceridine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2026to 28 Jul 2026
- Phase
- Phase 4
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 99 years.
- American Society of Anesthesiologists (ASA) physical status classification I, II, or III.
- Body mass index (BMI) between 18.5 and 28.0 kg/m².
- Scheduled for elective surgery under general anaesthesia.
- Able to understand the study procedures and provide written informed consent.
Who cannot join
- Preoperative upper respiratory tract infection symptoms (e.g., cough, expectoration, or fever) or a history of bronchial asthma or other conditions associated with increased airway reactivity.
- Severe cardiovascular disease (e.g., uncontrolled hypertension, recent myocardial infarction, or serious arrhythmia) or hepatic or renal dysfunction.
- Long-term opioid use, defined as continuous opioid use for more than 2 weeks within the 3 months prior to surgery.
- Known hypersensitivity to any study drug or anaesthetic agent used in this protocol.
- Anticipated difficult airway requiring awake intubation.
- Pregnancy or breastfeeding.
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
Tianmen First People's Hospital
Tianmen, Hubei, 431700
Jianmang Yu, Doc, 8613094293728, yujianmang@hbust.edu.cn
Zhixiong Xiang, Doc, 86-0728-5237400, 28612363@qq.com
About this study
Official title: Oliceridine vs Sufentanil for Cough During General Anesthesia Induction: A Randomized Controlled Trial
Sufentanil is the most widely used opioid analgesic for general anaesthesia induction; however, rapid intravenous bolus injection frequently triggers sufentanil-induced cough (SIC). In high-risk patients, SIC can cause abrupt elevation of intracranial and intraocular pressure and severe haemodynamic instability, posing a meaningful safety risk during the induction period.
Oliceridine, the first G protein-biased μ-opioid receptor agonist approved by the Food and Drug Administration in 2020, provides analgesia through μ-receptor activation while substantially reducing β-arrestin-2 recruitment. This biased signalling profile is hypothesised to raise the excitation threshold of airway C-fibres and thereby reduce the incidence of cough.
This prospective, single-centre, randomised, double-blind, parallel-group controlled trial directly compares oliceridine with sufentanil for general anaesthesia induction with respect to cough incidence, cough severity, haemodynamic responses, and perioperative safety, with the aim of providing evidence-based guidance for opioid selection during induction.
Read the detailed description
Rapid intravenous bolus injection of sufentanil frequently triggers sufentanil-induced cough (SIC). Although several prophylactic strategies have been described, all rely on adding a pretreatment agent on top of sufentanil - a reactive, patch-based approach that does not address the underlying cause. Oliceridine, a G protein-biased μ-opioid receptor agonist, preserves analgesic efficacy while substantially reducing β-arrestin-2 recruitment. This biased signalling profile is hypothesised to reduce cough risk at its origin by maintaining normal desensitisation of airway C-fibre transient receptor potential vanilloid 1 (TRPV1) channels and preserving β₂-adrenergic receptor-mediated bronchodilatory reserve in airway smooth muscle. Furthermore, oliceridine is formulated as a fumarate salt; because conventional fentanyl-class agents use citrate formulations, this difference eliminates a potential chemical cough stimulus at the formulation level. This prospective, single-centre, randomised, double-blind, parallel-group controlled trial directly compares oliceridine with sufentanil for general anaesthesia induction. A randomisation sequence will be generated by an independent statistician and concealed using sealed opaque envelopes; both the attending anaesthesiologist and the data recorder will remain blinded to group allocation throughout the study. Participants in the oliceridine group will receive intravenous oliceridine 0.05 mg/kg (elderly patients) or 0.06 mg/kg (younger patients) as a 2-second bolus, whereas participants in the sufentanil group will receive intravenous sufentanil 0.25μg/kg (elderly patients) or 0.3 μg/kg (younger patients) as a 2-second bolus. Cough will be observed for 2 minutes after injection, after which anaesthesia induction will be completed with propofol 2.0 mg/kg followed by rocuronium 0.6 mg/kg, and tracheal intubation will be performed. The primary outcome is the incidence of cough within 2 minutes of study drug injection. Secondary outcomes include cough severity (mild, moderate, or severe); haemodynamic variables - heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure - at time points T0 through T5; incidence of haemodynamic adverse events, including bradycardia and hypotension; and opioid-related adverse events, including chest wall rigidity, apnoea, and arterial oxygen saturation below 95%. Assuming a cough incidence of 40% in the sufentanil group and an expected reduction to 10% in the oliceridine group, with a two-sided α of 0.05 and 80% power, 30 participants per group are required; accounting for a 5% dropout rate, 31 participants will be enrolled per group, for a total of 62 participants. The trial will be conducted in the Department of Anaesthesiology, Tianmen First People's Hospital, Tianmen, Hubei, China (a tertiary Grade-A hospital).
- Conditions
- Cough, Anesthesia
- Being tested
- Oliceridine, Sufentanil
- Keywords
- Oliceridine, Sufentanil, Sufentanil-induced cough, G protein-biased agonist, Anesthesia induction
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OliceridineDrug
Also called TRV130, Oliceridine Fumarate
Oliceridine is administered as a single intravenous bolus over 2 seconds at a dose of 0.05 mg/kg in elderly patients (aged ≥65 years) or 0.06 mg/kg in younger patients (aged 18-64 years), immediately before propofol and rocuronium for anaesthesia induction.
SufentanilDrug
Also called Sufentanil Citrate
Sufentanil is administered as a single intravenous bolus over 2 seconds at a dose of 0.25 μg/kg in elderly patients (aged ≥65 years) or 0.3 μg/kg in younger patients (aged 18-64 years), immediately before propofol and rocuronium for anaesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Oliceridine Group | Experimental | Participants will receive intravenous oliceridine 0.05 mg/kg (elderly patients aged ≥65 years) or 0.06 mg/kg (younger patients aged 18-64 years), administered as a 2-second bolus injection. Cough will be observed for 2 minutes after injection, after which anaesthesia induction will be completed with propofol and rocuronium , followed by tracheal intubation. Receives: Drug: Oliceridine |
| Sufentanil Group | Active comparator | Participants will receive intravenous sufentanil 0.25 μg/kg (elderly patients aged ≥65 years) or 0.3 μg/kg (younger patients aged 18-64 years), administered as a 2-second bolus injection. Cough will be observed for 2 minutes after injection, after which anaesthesia induction will be completed with propofol and rocuronium , followed by tracheal intubation. Receives: Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Cough
The proportion of participants who cough at least once within 2 minutes of study drug injection. Cough is defined as a sudden, forceful expiratory effort occurring after drug administration and assessed by direct observation.
Measured: Within 2 minutes of study drug injection
Secondary outcomes (4)
Cough Severity
Cough severity is graded on a three-point scale: mild (1-2 coughs), moderate (3-4 coughs or sustained cough lasting <5 seconds), or severe (≥5 coughs or sustained cough lasting ≥5 seconds).
Measured: Within 2 minutes of study drug injection.
Heart rate
Heart rate recorded at baseline, immediately after drug injection, and at 1, 2, 3, and 5 minutes after injection .
Measured: From entry into the operating room to 10 minutes after administration of the study drug.
Blood pressure
Systolic blood pressure, diastolic blood pressure, and mean arterial pressure recorded at baseline, immediately after drug injection, and at 1, 2, 3, and 5 minutes after injection .
Measured: From entry into the operating room to 10 minutes after administration of the study drug.
Opioid-related Adverse Events
Incidence of chest wall rigidity, apnoea, and arterial oxygen saturation below 92% occurring after study drug injection and before tracheal intubation.
Measured: From study drug injection to completion of tracheal intubation, approximately 10 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start27 Jun 2026
- Primary completion25 Jul 2026 (estimated)
- Study completion28 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A two-arm parallel-group design comparing oliceridine with sufentanil during general anaesthesia induction.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiyou Wei
- Sponsor type
- University, hospital or other
- Collaborators
- Tianmen First People's Hospital
- Responsible party
- Sponsor-investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Shiyou Wei, Study chair, Tongji University Affiliated Shanghai Pulmonary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660380
- Sponsor's protocol ID
- Tianmen20260009
- Status last verified
- Jul 2026
- First submitted
- 14 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oliceridine vs Sufentanil for Cough During General Anesthesia Induction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07660380
- Acronym / sponsor ID
- Tianmen20260009
- Conditions
- Cough, Anesthesia
- Keywords
- Oliceridine, Sufentanil, Sufentanil-induced cough, G protein-biased agonist, Anesthesia induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Collaborators
- Tianmen First People's Hospital
- Study start
- 27 Jun 2026 (actual)
- Primary completion
- 25 Jul 2026 (estimated)
- Study completion
- 28 Jul 2026 (estimated)
- First posted
- 22 Jun 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.
Sufentanil is the most widely used opioid analgesic for general anaesthesia induction; however, rapid intravenous bolus injection frequently triggers sufentanil-induced cough (SIC). In high-risk patients, SIC can cause abrupt elevation of intracranial and intraocular pressure and severe haemodynamic instability, posing a meaningful safety risk during the induction period.
Oliceridine, the first G protein-biased μ-opioid receptor agonist approved by the Food and Drug Administration in 2020, provides analgesia through μ-receptor activation while substantially reducing β-arrestin-2 recruitment. This biased signalling profile is hypothesised to raise the excitation threshold of airway C-fibres and thereby reduce the incidence of cough.
This prospective, single-centre, randomised, double-blind, parallel-group controlled trial directly compares oliceridine with sufentanil for general anaesthesia induction with respect to cough incidence, cough severity, haemodynamic responses, and perioperative safety, with the aim of providing evidence-based guidance for opioid selection during induction.
Detailed description
Rapid intravenous bolus injection of sufentanil frequently triggers sufentanil-induced cough (SIC). Although several prophylactic strategies have been described, all rely on adding a pretreatment agent on top of sufentanil - a reactive, patch-based approach that does not address the underlying cause. Oliceridine, a G protein-biased μ-opioid receptor agonist, preserves analgesic efficacy while substantially reducing β-arrestin-2 recruitment. This biased signalling profile is hypothesised to reduce cough risk at its origin by maintaining normal desensitisation of airway C-fibre transient receptor potential vanilloid 1 (TRPV1) channels and preserving β₂-adrenergic receptor-mediated bronchodilatory reserve in airway smooth muscle. Furthermore, oliceridine is formulated as a fumarate salt; because conventional fentanyl-class agents use citrate formulations, this difference eliminates a potential chemical cough stimulus at the formulation level. This prospective, single-centre, randomised, double-blind, parallel-group controlled trial directly compares oliceridine with sufentanil for general anaesthesia induction. A randomisation sequence will be generated by an independent statistician and concealed using sealed opaque envelopes; both the attending anaesthesiologist and the data recorder will remain blinded to group allocation throughout the study. Participants in the oliceridine group will receive intravenous oliceridine 0.05 mg/kg (elderly patients) or 0.06 mg/kg (younger patients) as a 2-second bolus, whereas participants in the sufentanil group will receive intravenous sufentanil 0.25μg/kg (elderly patients) or 0.3 μg/kg (younger patients) as a 2-second bolus. Cough will be observed for 2 minutes after injection, after which anaesthesia induction will be completed with propofol 2.0 mg/kg followed by rocuronium 0.6 mg/kg, and tracheal intubation will be performed. The primary outcome is the incidence of cough within 2 minutes of study drug injection. Secondary outcomes include cough severity (mild, moderate, or severe); haemodynamic variables - heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure - at time points T0 through T5; incidence of haemodynamic adverse events, including bradycardia and hypotension; and opioid-related adverse events, including chest wall rigidity, apnoea, and arterial oxygen saturation below 95%. Assuming a cough incidence of 40% in the sufentanil group and an expected reduction to 10% in the oliceridine group, with a two-sided α of 0.05 and 80% power, 30 participants per group are required; accounting for a 5% dropout rate, 31 participants will be enrolled per group, for a total of 62 participants. The trial will be conducted in the Department of Anaesthesiology, Tianmen First People's Hospital, Tianmen, Hubei, China (a tertiary Grade-A hospital).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A two-arm parallel-group design comparing oliceridine with sufentanil during general anaesthesia induction.
| Arm | Type | Receives |
|---|---|---|
| Oliceridine Group | Experimental | Drug: OliceridineParticipants will receive intravenous oliceridine 0.05 mg/kg (elderly patients aged ≥65 years) or 0.06 mg/kg (younger patients aged 18-64 years), administered as a 2-second bolus injection. Cough will be observed for 2 minutes after injection, after which anaesthesia induction will be completed with propofol and rocuronium , followed by tracheal intubation. |
| Sufentanil Group | Active comparator | Drug: SufentanilParticipants will receive intravenous sufentanil 0.25 μg/kg (elderly patients aged ≥65 years) or 0.3 μg/kg (younger patients aged 18-64 years), administered as a 2-second bolus injection. Cough will be observed for 2 minutes after injection, after which anaesthesia induction will be completed with propofol and rocuronium , followed by tracheal intubation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 99 years.
- American Society of Anesthesiologists (ASA) physical status classification I, II, or III.
- Body mass index (BMI) between 18.5 and 28.0 kg/m².
- Scheduled for elective surgery under general anaesthesia.
- Able to understand the study procedures and provide written informed consent.
Key exclusion criteria (6 listed)
- Preoperative upper respiratory tract infection symptoms (e.g., cough, expectoration, or fever) or a history of bronchial asthma or other conditions associated with increased airway reactivity.
- Severe cardiovascular disease (e.g., uncontrolled hypertension, recent myocardial infarction, or serious arrhythmia) or hepatic or renal dysfunction.
- Long-term opioid use, defined as continuous opioid use for more than 2 weeks within the 3 months prior to surgery.
- Known hypersensitivity to any study drug or anaesthetic agent used in this protocol.
- Anticipated difficult airway requiring awake intubation.
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 |
|---|---|---|
| OliceridineAlso: TRV130, Oliceridine FumarateOliceridine is administered as a single intravenous bolus over 2 seconds at a dose of 0.05 mg/kg in elderly patients (aged ≥65 years) or 0.06 mg/kg in younger patients (aged 18-64 years), immediately before propofol and rocuronium for anaesthesia induction. | Drug | Oliceridine Group |
| SufentanilAlso: Sufentanil CitrateSufentanil is administered as a single intravenous bolus over 2 seconds at a dose of 0.25 μg/kg in elderly patients (aged ≥65 years) or 0.3 μg/kg in younger patients (aged 18-64 years), immediately before propofol and rocuronium for anaesthesia induction. | Drug | Sufentanil Group |
Primary outcome
Incidence of Cough
Time frame: Within 2 minutes of study drug injection
The proportion of participants who cough at least once within 2 minutes of study drug injection. Cough is defined as a sudden, forceful expiratory effort occurring after drug administration and assessed by direct observation.
4 secondary outcomes
Cough Severity
Time frame: Within 2 minutes of study drug injection.
Heart rate
Time frame: From entry into the operating room to 10 minutes after administration of the study drug.
Blood pressure
Time frame: From entry into the operating room to 10 minutes after administration of the study drug.
Opioid-related Adverse Events
Time frame: From study drug injection to completion of tracheal intubation, approximately 10 minutes.
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 21 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Shiyou Wei study chair
Tongji University Affiliated Shanghai Pulmonary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oliceridine and Sufentanil in people with Cough and Anesthesia, run by Shiyou Wei 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 5 inclusion and 6 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 21 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shiyou Wei, MD. (15601680288, lovewishyou@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Cough (time frame: Within 2 minutes of study drug injection). 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 21 Jul 2026.