Oliceridine vs Sufentanil for Cough During Anesthesia Induction

NCT07660380 | Recruiting Phase 4 DMC

• 1 other identifier: Tianmen20260009
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cough; Anesthesia

Keywords

Oliceridine; Sufentanil; Sufentanil-induced cough; G protein-biased agonist; Anesthesia induction

Outcome Measures

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.

  Within 2 minutes of study drug injection

Secondary Outcomes (4)

• Cough Severity

  Within 2 minutes of study drug injection.

• Heart rate

  From entry into the operating room to 10 minutes after administration of the study drug.

• Blood pressure

  From entry into the operating room to 10 minutes after administration of the study drug.

• Opioid-related Adverse Events

  From study drug injection to completion of tracheal intubation, approximately 10 minutes.

Study Arms (2)

Oliceridine Group

EXPERIMENTAL

Participants will receive intravenous oliceridine 0.05 mg/kg (elderly patients aged ≥65 years) or 0.06 mg/kg (younger patients aged 18-64 years), administered as a 2-second bolus injection. Cough will be observed for 2 minutes after injection, after which anaesthesia induction will be completed with propofol and rocuronium , followed by tracheal intubation.

Drug: Oliceridine

Sufentanil Group

ACTIVE COMPARATOR

Participants will receive intravenous sufentanil 0.25 μg/kg (elderly patients aged ≥65 years) or 0.3 μg/kg (younger patients aged 18-64 years), administered as a 2-second bolus injection. Cough will be observed for 2 minutes after injection, after which anaesthesia induction will be completed with propofol and rocuronium , followed by tracheal intubation.

Drug: Sufentanil

Interventions

Oliceridine DRUG

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.

Also known as: TRV130, Oliceridine Fumarate

Oliceridine Group

Sufentanil DRUG

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.

Also known as: Sufentanil Citrate

Sufentanil Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shiyou Wei: lead
• Tianmen First People's Hospital: collaborator

Study Sites (1)

Tianmen First People's Hospital

Tianmen, Hubei, 431700, China

RECRUITING

MeSH Terms

Conditions

Cough

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Sufentanil

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shiyou Wei

  Tongji University Affiliated Shanghai Pulmonary Hospital

  STUDY CHAIR

Central Study Contacts

Shiyou Wei, MD.

CONTACT

15601680288; lovewishyou@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study drugs will be prepared by an unblinded nurse. Participants, the attending anaesthesiologist, and the outcomes assessor will remain blinded to group allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology

Model Details: A two-arm parallel-group design comparing oliceridine with sufentanil during general anaesthesia induction.

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 22, 2026
• Study Start: June 27, 2026
• Primary Completion: July 25, 2026
• Study Completion: July 28, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)