About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Oliceridine
- Sufentanil
Treatment groups
Sponsors and collaborators
Shiyou Wei
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Sponsor institution
Tianmen First People's Hospital
Collaborator