drugset / Trial / NCT07660380

Oliceridine vs Sufentanil for Cough During Anesthesia Induction

NCT07660380

Phase 4 Not yet recruiting 62 enrolled Shiyou Wei Tianmen First People's Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-06-22
Primary completion
2026-07-01
Completion
2026-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Oliceridine Other / unclassified 0.05 mg/kg Intravenous
Subject Oliceridine Other / unclassified 0.06 mg/kg Intravenous
Comparator Sufentanil Other / unclassified 0.4 ug/kg Intravenous
Comparator Sufentanil Other / unclassified 0.5 ug/kg Intravenous

Indications

No indication recorded.