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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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041