Oliceridine vs Sufentanil for Cough During Anesthesia Induction
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Oliceridine
DrugOliceridine 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.
Sufentanil
DrugSufentanil 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Oliceridine GroupExperimental treatment 1 intervention
Group B: Sufentanil GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Cough
The proportion of participants who cough at least once within 2 minutes of study drug injection. Cough is defined as a sudden, forceful expiratory effort occurring after drug administration and assessed by direct observation.
Time frame
Within 2 minutes of study drug injectionSecondary outcomes
1
Cough Severity
Cough severity is graded on a three-point scale: mild (1-2 coughs), moderate (3-4 coughs or sustained cough lasting \<5 seconds), or severe (≥5 coughs or sustained cough lasting ≥5 seconds).
Time frame
Within 2 minutes of study drug injection.2
Heart rate
Heart rate recorded at baseline, immediately after drug injection, and at 1, 2, 3, and 5 minutes after injection .
Time frame
From entry into the operating room to 10 minutes after administration of the study drug.3
Blood pressure
Systolic blood pressure, diastolic blood pressure, and mean arterial pressure recorded at baseline, immediately after drug injection, and at 1, 2, 3, and 5 minutes after injection .
Time frame
From entry into the operating room to 10 minutes after administration of the study drug.4
Opioid-related Adverse Events
Incidence of chest wall rigidity, apnoea, and arterial oxygen saturation below 92% occurring after study drug injection and before tracheal intubation.
Time frame
From study drug injection to completion of tracheal intubation, approximately 10 minutes.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shiyou Wei
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Sponsor institution
Tianmen First People's Hospital
Collaborator
Source ClinicalTrials.gov