Effects and Safety of Oliceridine in Anesthesia Induction:A Randomised Controlled Trial

NCT07372209 | Completed

• 1 other identifier: 2024-074-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

to investigate whether oliceridine is safe and effective for induction of anesthesia by comparing henodynamic changes before and after endotracheal intubation with sufentanil

Conditions

General Anesthetic; Intubation; Gynecological Laparoscopic Surgery

Outcome Measures

Primary Outcomes (2)

• blood pressure

  baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation

• heart beat

  baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation

Secondary Outcomes (1)

• adverse reactions

  from the administration of sufentanil or oliceridine until discharge from the post-anesthesia care unit (PACU)

Study Arms (2)

sufentanil

ACTIVE COMPARATOR

0.5μg/kg of sufentanil was used for anesthesia induction

Drug: Sufentanil

Oliceridine

EXPERIMENTAL

0.13mg/kg oliceridine was used for anesthesia induction

Drug: Oliceridine

Interventions

Oliceridine DRUG

Oliceridine is diluted to a 1mg/kg injection solution

Oliceridine

Sufentanil DRUG

sufentanil is diluted to a 5μg/ml injection solution

sufentanil

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years;
• American Society of Anesthesiologists (ASA) physical status I-II;
• Elective gynecologic laparoscopic surgery;
• Expected operative time 60-180 minutes;

You may not qualify if:

• Severe cardiovascular instability (e.g., acute decompensated heart failure, acute myocardial infarction, or life-threatening arrhythmia);
• Uncontrolled hypertension;
• Severe renal or hepatic dysfunction;
• Severe mental disorder or psychiatric illness;
• Known allergy or hypersensitivity to opioids;
• History of alcohol abuse or opioid addiction;
• Anticipated difficult airway;
• Pregnancy or lactation;

Sponsors & Collaborators

• Tangshan Maternal and Child Health Hospital: lead

Study Sites (1)

Tangshan Maternal and Child Health Hospital

Tangshan, Hebei, 063000, China

Location

Related Publications (6)

• Simons P, van der Schrier R, van Lemmen M, Jansen S, Kuijpers KWK, van Velzen M, Sarton E, Nicklas T, Michalsky C, Demitrack MA, Fossler M, Olofsen E, Niesters M, Dahan A. Respiratory Effects of Biased Ligand Oliceridine in Older Volunteers: A Pharmacokinetic-Pharmacodynamic Comparison with Morphine. Anesthesiology. 2023 Mar 1;138(3):249-263. doi: 10.1097/ALN.0000000000004473.

  PMID: 36538359 BACKGROUND

• Stahl EL, Schmid CL, Acevedo-Canabal A, Read C, Grim TW, Kennedy NM, Bannister TD, Bohn LM. G protein signaling-biased mu opioid receptor agonists that produce sustained G protein activation are noncompetitive agonists. Proc Natl Acad Sci U S A. 2021 Nov 30;118(48):e2102178118. doi: 10.1073/pnas.2102178118.

  PMID: 34819362 BACKGROUND

• Yang W, Zhou R, Zhou X, Chen X, Zhou D, Zhang X. Effective Dose of Oliceridine Fumarate Co-Administered with Remimazolam in Suppressing Gastroscope Insertion Responses for Adults. Drug Des Devel Ther. 2025 Jun 10;19:5033-5041. doi: 10.2147/DDDT.S527586. eCollection 2025.

  PMID: 40524805 BACKGROUND

• Ma B, Li Y, Leng C, Ji A, Zhang N, Tao X, Cao Q, Wang S. A Comparative Evaluation of the Safety and Efficacy of Oliceridine and Sufentanil in Gastrointestinal Endoscopy: A Single-Center, Randomized Controlled Trial. Drug Des Devel Ther. 2025 Jun 17;19:5111-5121. doi: 10.2147/DDDT.S512529. eCollection 2025.

  PMID: 40546662 BACKGROUND

• Iannuzzi E, Iannuzzi M, Cirillo V, Viola G, Parisi R, Cerulli A, Chiefari M. Peri-intubation cardiovascular response during low dose remifentanil or sufentanil administration in association with propofol TCI. A double blind comparison. Minerva Anestesiol. 2004 Mar;70(3):109-15.

  PMID: 14997083 BACKGROUND

• Teong CY, Huang CC, Sun FJ. The Haemodynamic Response to Endotracheal Intubation at Different Time of Fentanyl Given During Induction: A Randomised Controlled Trial. Sci Rep. 2020 Jun 1;10(1):8829. doi: 10.1038/s41598-020-65711-9.

  PMID: 32483139 BACKGROUND

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle nvestigator

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: January 28, 2026
• Study Start: October 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)