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

January 25, 2026 updated by: Yu Zhang, Tangshan Maternal and Child Health Hospital

Study of Effects and Underlying Mechanisms of Analgesic Drugs on Inflammatory Pathways and Immune Function in Patients With Endometrial Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Tangshan, Hebei, China, 063000
        • Tangshan Maternal and Child Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sufentanil
0.5μg/kg of sufentanil was used for anesthesia induction
Drug: Sufentanil
sufentanil is diluted to a 5μg/ml injection solution
Experimental: Oliceridine
0.13mg/kg oliceridine was used for anesthesia induction
Drug: Oliceridine
Oliceridine is diluted to a 1mg/kg injection solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood pressure
Time Frame: baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation
baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation
heart beat
Time Frame: baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation
baseline, at the moment of intubation, right after intubation, 1 minute、3 minutes, and 5 minutes after intubation

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse reactions
Time Frame: from the administration of sufentanil or oliceridine until discharge from the post-anesthesia care unit (PACU)
from the administration of sufentanil or oliceridine until discharge from the post-anesthesia care unit (PACU)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tangshan Maternal and Child Health Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Actual)

December 15, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

September 3, 2025

First Submitted That Met QC Criteria

January 25, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-074-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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