Oliceridine vs Sufentanil for Cough During Anesthesia Induction

ConditionsCoughAnesthesia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorShiyou Wei

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

62 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Shiyou Wei

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Sponsor institution

Tianmen First People's Hospital

Collaborator