A Phase 4 interventional study of Oliceridine and Sufentanil in Cough and Anesthesia, sponsored by Shiyou Wei. Recruiting at 1 site in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Shiyou Wei · Phase 4, Interventional, and Treatment
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.
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).
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 62 is below the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Shiyou Wei is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Oliceridine
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.
Drug: Sufentanil
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.
Also known as: TRV130, Oliceridine Fumarate
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.
Also known as: Sufentanil Citrate
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.
Time frame: Within 2 minutes of study drug injection
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).
Time frame: 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 .
Time frame: 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 .
Time frame: 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.
Time frame: From study drug injection to completion of tracheal intubation, approximately 10 minutes.
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Jul 2026, 0 months after the start.
Of 20 phase 4 interventional studies under Cough, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 33. This study's planned 0 months is below that.
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Studies of the drug tested here: Oliceridine
Shiyou Wei