Effect of oliceridine on stress response in mechanically ventilated ICU patients

ISRCTN	ISRCTN65709956
DOI	https://doi.org/10.1186/ISRCTN65709956
Sponsor	Wu Jieping Medical Foundation
Funder	Wu Jieping Medical Foundation

Submission date: 14/08/2026
Registration date: 28/08/2026
Last edited: 28/08/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Wan-Jie Gu
Public, Scientific, Principal investigator

The First Affiliated Hospital of Jinan University, 613 Huangpu Avenue West
Guangzhou
510630
China

ORCID ID	0000-0003-4923-8282
Phone	+86 (0)15850546835
Email	guwanjie@jnu.edu.cn

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Effect of oliceridine on stress response in mechanically ventilated ICU patients: a randomized controlled trial
Study objectives	This study aims to investigate the efficacy and safety of oliceridine, a novel G-protein–biased μ-opioid receptor agonist, for analgesia in mechanically ventilated ICU patients.
Ethics approval(s)	Approved 27/08/2025, Scientific Research Ethics Committee of the First Affiliated Hospital of Jinan University (The First Affiliated Hospital of Jinan University, 613 Huangpu Avenue West, Guangzhou, 510632, China; +86 (0)38688217; ofyyllbgs@jnu.edu.cn), ref: KY-2025-205
Health condition(s) or problem(s) studied	Pain in mechanically ventilated patients
Intervention	This is a prospective, randomized, active-controlled, parallel-group interventional study. Participants are randomly assigned in a 1:1 ratio to receive either oliceridine fumarate (intervention group) or remifentanil hydrochloride (control group). Randomization is performed using a computer-generated random number table, with participants allocated to one of the two treatment arms in a 1:1 ratio. In the intervention group, oliceridine fumarate is administered intravenously, with a loading dose of 0.03 mg/kg followed by a continuous maintenance infusion starting at 0.0018 mg/kg/min. The infusion rate may be titrated within a range of 0.0006 to 0.045 mg/kg/min according to clinical requirements. In the control group, remifentanil hydrochloride is administered intravenously, with a loading dose of 1 μg/kg followed by a continuous maintenance infusion starting at 0.06 μg/kg/min. The infusion rate may be titrated within a range of 0.02 to 0.15 μg/kg/min as clinically indicated. The study duration is from intubation to extubation.
Intervention type	Drug
Phase	Phase III/IV
Drug / device / biological / vaccine name(s)	Oliceridine, remifentanil
Primary outcome measure(s)	Total cortisol level measured using enzyme-linked immunosorbent assay (ELISA) at baseline and 1-2 days post-intervention, twice a day, at 8:00 AM and 4:00 PM
Key secondary outcome measure(s)	Inflammatory biomarkers, including IL-1β, IL-6, TNF-α, measured using enzyme-linked immunosorbent assay (ELISA) at baseline and 1-2 days post-intervention Duration of mechanical ventilation measured using the duration of mechanical ventilation from intubation to extubation at during mechanical ventilation Length of stay measured using patient records at end of stay Mortality measured using patient records at until hospital discharge or in-hospital death Gastrointestinal dysfunction measured using the timing and frequency of flatulence, dry mouth, dyspepsia, diarrhea, and constipation using patient records at duration of treatment
Completion date	01/06/2028

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	1. Adult ICU patients requiring endotracheal intubation with mechanical ventilation, and expected to need sedation and analgesia for >24 hours after randomization 2. Target sedation level within a Richmond Agitation-Sedation Scale (RASS) score of –3 to 0 3. Age ≥18 years and <80 years, regardless of sex 4. Body mass index (BMI) between 18 and 30 kg/m² 5. Patients or their legally authorized representatives fully understand the purpose and significance of the study, voluntarily agree to participate, and provide written informed consent
Key exclusion criteria	1. Known hypersensitivity or allergy to opioids or related agents 2. Receipt of sedation and analgesia for more than 3 consecutive days prior to informed consent, either in the ICU or on a general ward before ICU admission 3. Patients with any of the following medical histories or evidence of increased risk related to sedation/analgesia during the screening period: 3.1. Neuropsychiatric disorders: Psychiatric diseases (e.g., schizophrenia, depression) or cognitive impairment; history of psychiatric or anesthetic drug abuse; history of alcohol abuse within 3 months prior to screening; history of illicit drug use; long-term use of psychotropic medications 3.2. Severe hepatic or renal impairment, including patients on dialysis 3.3. Neurological conditions: Status epilepticus, convulsions; traumatic brain injury, intracranial hypertension, cerebral aneurysm; Glasgow Coma Scale (GCS) score ≤12; high spinal cord injury or quadriplegia 3.4. Life expectancy ≤48 hours 4. Pregnant or lactating women 5. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this clinical trial
Date of first enrolment	01/02/2026
Date of final enrolment	01/02/2028

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

14/08/2026: Study's existence confirmed by the Scientific Research Ethics Committee of the First Affiliated Hospital of Jinan University.