Oliceridine vs Sufentanil for Cough During Anesthesia Induction (NCT07660380) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Oliceridine vs Sufentanil for Cough During Anesthesia Induction
China62 participantsStarted 2026-06-22
Plain-language summary
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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Cough
Timeframe: Within 2 minutes of study drug injection