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NOT YET RECRUITING
NCT07660380
PHASE4

Oliceridine vs Sufentanil for Cough During Anesthesia Induction

Sponsor: Shiyou Wei

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2026-06-22

Completion Date

2026-07-01

Last Updated

2026-06-23

Healthy Volunteers

No

Conditions

Interventions

DRUG

Oliceridine

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.

DRUG

Sufentanil

Sufentanil is administered as a single intravenous bolus over 2 seconds at a dose of 0.4 μg/kg in elderly patients (aged ≥65 years) or 0.5 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