RecruitingPhase 4NCT07660380

Oliceridine vs Sufentanil for Cough During Anesthesia Induction

Oliceridine vs Sufentanil for Cough During General Anesthesia Induction: A Randomized Controlled Trial


Sponsor

Shiyou Wei

Enrollment

62 participants

Start Date

Jun 27, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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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Interventions

DRUGOliceridine

Oliceridine is administered as a single intravenous bolus over 2 seconds at a dose of 0.05 mg/kg in elderly patients (aged ≥65 years) or 0.06 mg/kg in younger patients (aged 18-64 years), immediately before propofol and rocuronium for anaesthesia induction.

DRUGSufentanil

Sufentanil is administered as a single intravenous bolus over 2 seconds at a dose of 0.25 μg/kg in elderly patients (aged ≥65 years) or 0.3 μg/kg in younger patients (aged 18-64 years), immediately before propofol and rocuronium for anaesthesia induction.


Locations(1)

Tianmen First People's Hospital

Tianmen, Hubei, China

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NCT07660380


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