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Recruiting NCT07660380

Oliceridine vs Sufentanil for Cough During Anesthesia Induction

Conditions: Cough, Anesthesia

Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 62
Sponsor: Shiyou Wei

Location: Tianmen First People's Hospital Tianmen Hubei

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07660380). StuddyBuddy aggregates publicly available trial information.