← Back to all trials
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.
Source: ClinicalTrials.gov (NCT07660380). StuddyBuddy aggregates publicly available trial information.