Status:

COMPLETED

A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal

Lead Sponsor:

Jiangsu HengRui Medicine Co., Ltd.

Conditions:

Pain

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Able and willing to provide a written informed consent
  • Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal
  • Male or female
  • Meet the body mass index standard
  • Conform to the ASA Physical Status Classification
  • Exclusion Criteria
  • Subjects with a history of difficult airway
  • Subjects with a history of mental illness
  • Subjects with a history of cognitive impairment epilepsy
  • Subjects with a history of myocardial infarction or unstable angina pectoris
  • Subjects with atrioventricular block or cardiac insufficiency
  • Subjects with a history of ischemic stroke or transient ischemic attack
  • Subjects with poor blood pressure control after medication
  • Subject with a history of substance abuse and drug abuse
  • Abnormal values in liver function
  • Subjects with an oxygen saturation below 90% on room air
  • Allergic to drugs that may be used during the study
  • Pregnant or nursing women
  • No birth control during the specified period of time
  • Participated in clinical trials of other drugs (received experimental drugs)
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial

Exclusion

    Key Trial Info

    Start Date :

    May 13 2021

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 22 2021

    Estimated Enrollment :

    228 Patients enrolled

    Trial Details

    Trial ID

    NCT04852003

    Start Date

    May 13 2021

    End Date

    July 22 2021

    Last Update

    February 10 2022

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    West China Hospital of Sichuan University

    Chengdu, Sichuan, China, 610041